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Diss Factsheets

Administrative data

Description of key information

The potential of the test item to cause damage to skin or eyes was assessed by single application onto skin or into eyes according OECD guideline 404 and 405 under GLP. Irreversible reactions in two out of three animals were observed after single topical application and the test material is considered to be irritating to the skin. No effects were observed after installation into the eye, the test item is therefore not considered to be irritating to the eye.

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
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well documented, according to OECD guideline and GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories, Netherlands
- Age at study initiation: Approx. 3-4 months
- Weight at study initiation: 3.33 kg – 3.64 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/ - 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin sites of the same animal.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4h
Observation period:
Immediately after removal of the patch, approx. 1, 24, 48 and 72 h after removal of the patch and then in weekly intervals up to day 14.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsolateral part of the trunk
- % coverage: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test item was removed at the end of the exposure period with Lutrol® E 400 (= Polyethylenglycol, BASF SE) and Lutrol® / water (1 : 1).

SCORING SYSTEM: according to the quoted guidelines
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
The first animal revealed very slight erythema (grade 1) immediately after removal of the patch until 1 hour after removal of the patch and was free of local skin reactions until hour 48. Thereafter, very slight erythema was observed again at hour 72. This finding increased to moderate erythema (grade 3) and slight edema (grade 2) on day 7. Both findings were noted beyond the application area on day 7. In addition, a yellowish to whitish discolored application area was seen on day 7. On day 14 scaling without any erythema was noted in this animal.
The second animal revealed very slight erythema (grade 1) immediately after removal of the patch until 1 hour, which increased to well-defined erythema (grade 2) at hour 24, but regressed to very slight erythema from hour 48 until hour 72. Thereafter, well-defined erythema was seen again on study day 7, which decreased finally to very slight erythema on day 14. From hour 24 until day 7, erythema was noted beyond the application area.
The third animal revealed very slight erythema at hour 1 after removal of the patch. This finding increased to well-defined erythema from hour 24 until hour 72. On day 7, very slight erythema was noted again. From hour 24 until day 7, erythema was noted beyond the application area, while scaling was seen on day 7.

The cutaneous reactions were reversible in one animal within 14 days after removal of the patch. In the other two animals, very slight erythema or scaling only were still noted at study termination on day 14.

Mean scores over 24, 48 and 72 hours for each animal were 0.3, 1.3 and 2.0 for erythema and 0.0, 0.0 and 0.0 for edema.
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well documented, according to OECD guidelines and GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories, Netherlands
- Age at study initiation: Approx. 3-4 months
- Weight at study initiation: 2.34 kg – 3.20 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/ - 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Observation period (in vivo):
reading 1, 24, 48 and 72 h after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
About (but not less than) 24 hours after application of the test item the treated eye of the animal(s) was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.

SCORING SYSTEM: according to OECD guideline and Commission Directive 67/548/EEC

TOOL USED TO ASSESS SCORE: An additional eye examination was performed 24 h and 48 h after application with the instillation of a fluorescein solution.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritant / corrosive response data:
No corneal and iris lesions were noted in any animal at any examination time point. Even after instillation of fluorescein after 24 and 48 hours no corneal lesions were detectable.

Slight conjunctival redness (grade 1) was noted in all animals at hour 1 after application and persisted in one animal until hour 24.
Slight conjunctival chemosis (grade 1) was noted in two animals at hour 1 after application; in the third animal moderate conjunctival chemosis (grade 2) was noted at the same time point.
Slight discharge (grade 1) was noted in one animal at hour 1 after application. In a second animal obvious discharge (grade 2) was seen at hour 1 after application.
Additional findings like injected scleral vessels in a circular area were noted in two animals at hour 1 after application only.

The ocular reactions were reversible in two animals within 24 hours and in a third animal within 48 hours after application.

Mean scores calculated for each animal over 24, 48 and 72 hours were 0.0, 0.0 and 0.0 for corneal opacity, 0.0, 0.0 and 0.0 for iris lesions, 0.0, 0.3 and 0.0 for redness of the conjunctiva and 0.0, 0.0 and 0.0 for chemosis.
Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The potential of the test item to cause acute dermal irritation or corrosivity was assessed by a single topical application of an amount of 0.5 mL of the test item for 4 hours to the intact skin of three New Zealand White rabbits (stepwise procedure starting with one animal and supplementing two additional animals), using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. Mean scores over 24, 48 and 72 hours for each animal were 0.3, 1.3 and 2.0 for erythema and 0.0, 0.0 and 0.0 for edema. Considering the described cutaneous reactions, the irreversibility in two animals as well as the average score for irritation, the test material shows a skin irritating potential under the test conditions chosen.

The potential of the test item to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 mL of the undiluted test item to one eye of three New Zealand White rabbits (stepwise procedure starting with one animal and supplementing two additional animals). About, and not less than 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application. Additional eye examinations were performed at 24 and 48 h after application with the instillation of a fluorescein solution. Due to a negative finding at the 24 and 48 hour reading (no corneal lesions detectable with fluorescein) no further readings were performed with the aid of fluorescein. No corneal and iris lesions were noted in any animal at any examination timepoint. Considering the described ocular reactions as well as the average score for irritation, the test substance does not show an eye irritating potential under the test conditions chosen.


Effects on skin irritation/corrosion: irritating

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008


The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for eye irritation under Regulation (EC) No. 1272/2008. The substance is considered to be irritanting to the skin and therefore classified as skin irrit. 2, H315.