Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin irritation-non-irritating for rabbits (similar to OECD TG 404).
Eye irritation-non-irritating for rabbits (similar to OECD TG 406)

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report similar or equivalent to OECD 404. GLP.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
multiple test sites per animal, including abraded test sites and occluded sites. 4h exposure was occluded
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Inc. Denver, PA
- Age at study initiation: young adult
- Weight at study initiation: ~ 2.0-4.0 kg
Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4-hour (occluded) and 24 hours (occluded and non-occluded)
Observation period:
Following the 4 hour exposure, the test sites were evaluated for dermal irritation at 4.5, 28, 52, and 76 hours. Following the 24 hour exposure, clinical observations were recorded at approximately 1 and 4 hours post-dosing and the sites were evaluated for dermal irritation at 26 and 72 hours post-exposure.
Number of animals:
6 animals (3/sex).
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
female
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
female
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
female
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
male
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
male
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
male
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
female
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure effects were fully reversible within 72 hours for all but one animal
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
male
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
female
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
female
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
female
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
male
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
male
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
male
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Irritation parameter:
edema score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: intact skin, 4 hour occlusive exposure
Other effects:
4 hour exposure of abraded skin under occlusive conditions resulted in a combined erythema mean of 0.47 and a combined edema mean of 0.067. Erythema was not fully reversible within 72 hours whereas edema was fully reversible within 48 hours.

24 hour exposure of non-abraded skin under non-occlusive conditions resulted in a combined erythema mean score of 1.0 at 26h and 0.2 at 72h; and a combined edema mean score of 1.0 at 26h and 0 at 72 hours after onset of exposure.

24 hour exposure of intact skin under occlusive conditions resulted in a combined erythema mean of 1.0 and the combined edema mean was 0.75; both the erythema and edema were not fully reversible within 72 hours. 24 hour exposure of abraded skin under occlusive conditions resulted in a combined erythema mean of 1.0 and a combined edema mean of 0.65; both erythema and edema were not fully reversible within 72 hours.

24 hour exposure of intact skin under non-occlusive conditions resulted in a combined erythema mean of 0.6 and the combined edema mean was 0.55; the edema, but not the erythema, was fully reversible within 72 hours. 24 hour exposure of abraded skin under occlusive conditions resulted in a combined erythema mean of 0.85 and a combined edema mean of 0.5; the edema, but not the erythema, was fully reversible within 72 hours.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean erythema and edema scores for the study substance were 0.36 and 0.1 (4 hour occluded), 1.0 and 0.75 (24 hour occluded), and 0.6 and 0.5 (24 hour non-occluded), respectively.This finding does not warrant classification of the study substance as a dermal irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) nor as an R38 skin irritant under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

The study substance was administered to the skin of New Zealand White rabbits. Test sites were selected on both the left and right flank of each animals and designated as anterior (4-hour, occluded), middle (24-hour, occluded), and posterior (24-hour, non-occluded). All sites of the right flank were abraded. 0.5 ml of the study substance was applied to each test site. Following the 4 hour exposure, the test sites were evaluated for dermal irritation at 1/2, 24, 48, and 72 hours according to the Draize method. Following the 24 hour exposures, both test sites were evaluated at 26 and 72 hours. Clinical observations were recorded at approximately 1 and 4 hours post-dosing. Slight to moderate erythema and edema were noted at each test site. Soft stool, decreased fecal output, and decreased food consumption were observed in one or more animals. The mean erythema and edema scores for the study substance were 0.36 and 0.1 (4 hour occluded), 1.0 and 0.75 (24 hour occluded), and 0.6 and 0.5 (24 hour non-occluded), respectively.This finding does not warrant classification of the study substance as a dermal irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) nor as an R38 skin irritant under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report similar or equivalent to OECD 405. GLP.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
last observation timepoint at 72 hr
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hazleton Research Products, Inc (Denver PA)
- Age at study initiation: young adult
- Weight at study initiation: ~ 2.0-4.0 kg

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Single instillation; the eyelids were gently held together for one second
Observation period (in vivo):
Clinical observations were recorded at approximately 1 and 4 hours post-dosing and daily thereafter except on weekends.
Number of animals or in vitro replicates:
3 per sex
Details on study design:
SCORING SYSTEM: Draize method: Evaluations were made at 1, 24, 48, and 72 hours.

TOOL USED TO ASSESS SCORE: sodium fluorescein
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
male
Time point:
24 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
male
Time point:
24 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
male
Time point:
24 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #4
Remarks:
female
Time point:
24 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #5
Remarks:
female
Time point:
24 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #6
Remarks:
female
Time point:
24 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
male
Time point:
48 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
male
Time point:
48 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
male
Time point:
48 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #4
Remarks:
female
Time point:
48 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #5
Remarks:
female
Time point:
48 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #6
Remarks:
female
Time point:
48 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
male
Time point:
72 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
male
Time point:
72 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
male
Time point:
72 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #4
Remarks:
female
Time point:
72 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #5
Remarks:
female
Time point:
72 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
cornea opacity score
Basis:
animal #6
Remarks:
female
Time point:
72 h
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
male
Time point:
24 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
male
Time point:
24 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #4
Remarks:
female
Time point:
24 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #5
Remarks:
female
Time point:
24 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #6
Remarks:
female
Time point:
24 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
male
Time point:
48 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
male
Time point:
48 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
male
Time point:
48 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #4
Remarks:
female
Time point:
48 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #5
Remarks:
female
Time point:
48 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #6
Remarks:
female
Time point:
48 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
male
Time point:
72 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
male
Time point:
72 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
male
Time point:
72 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #4
Remarks:
female
Time point:
72 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #5
Remarks:
female
Time point:
72 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
iris score
Basis:
animal #6
Remarks:
female
Time point:
72 h
Max. score:
2
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Remarks:
72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Remarks:
female
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #5
Remarks:
female
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Remarks:
female
Time point:
24 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
male
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
male
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
male
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Remarks:
female
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #5
Remarks:
female
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Time point:
48 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
male
Time point:
72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #4
Remarks:
female
Time point:
72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #5
Remarks:
female
Time point:
72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #6
Remarks:
female
Time point:
72 h
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
male
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
male
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
female
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
female
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #6
Remarks:
female
Time point:
24 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
male
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
male
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
male
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
female
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
female
Time point:
48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #6
Remarks:
female
Time point:
48 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
male
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #4
Remarks:
female
Time point:
72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #5
Remarks:
female
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: 72 hours was the last observation timepoint
Irritant / corrosive response data:
Mean DRAIZE scores for six animals at 24, 48 and 72 hrs respectively:
Corneal Opacity: 0, 0, 0
Iris Lesion: 0, 0, 0
Conjunctivae: 5.7, 3.3, 1.7
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for the study substance were 0, 0, 0.9, and 0.4, respectively. These findings do not warrant classification of the study substance as an ocular irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
Executive summary:

The study substance was administered to one eye of six New Zealand White rabbits to assess for ocular irritation; the other eye was used as a control. Clinical observations were made 1 and 4 hours immediately after treatment and daily thereafter. Ocular damage was assessed and scored according to the Draize method. Mild conjunctival redness and/or swelling were noted in all animals at 24 and/or 48 hours post-dosing. Discharge was noted sporadically throughout the study. The mean corneal opacity, iris lesion, conjunctivae redness, and chemosis scores for the study substance were 0, 0, 0.9, and 0.4, respectively. These findings do not warrant classification of the study substance as an ocular irritant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin: The dermal irritation potential of the study substance has been evaluated under occluded conditions. The results indicate negligible dermal irritation.

 

Eye: The ocular irritation potential of the study substance has been evaluated in a manner similar or equivalent to currently established OECD guidelines. The results indicate negligible ocular irritation.

 

Respiratory: The respiratory tract irritation potential of the study substance is not known, as no data are available for this endpoint.

Justification for classification or non-classification

Based on assessment of the available data for the study substance, classification is not warranted as an eye or skin irritant under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.


There is no evidence of irritation to the respiratory tract warranting classification.