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Diss Factsheets

Administrative data

Description of key information

The test item was tested for skin irritation in a GLP study according to OECD 404 in rabbits. The test item is considered to be a non-irritant to the skin of the rabbit.
The test item was tested for eye irritation in a GLP study according to OECD 405 in rabbits. The test item is considered to be a non-irritant to the eye of the rabbit.

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:
1999-01-13 to 1999-04-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant Guideline study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted July 17, 1992
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN, USA
- Age at study initiation: approximately seven weeks
- Weight at study initiation: ranging from 2552 to 2704 g for males and 2220 to 2477 g for females
- Fasting period before study: no
- Housing: individually in suspended stainless steel cages.
- Diet: PMI Certified Rodent Chow® #5322 (Purina Mills, Inc.) ad libitum
- Water: municipal tap water ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18°C to 20°C
- Humidity: 26 to 49%
- Air changes: 10 to 15 air changes per hour
- Photoperiod: 12-hour light / 12-hour dark cycle
Type of coverage:
semiocclusive
Preparation of test site:
other: by animal clipper
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g per animal

VEHICLE
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
approximately 1, 24, 48 and 72 hours after exposure
Number of animals:
6 (3 male and 3 female)
Details on study design:
TEST SITE
- Area of exposure: approximately 1 inch x 1 inch (2.54 x 2.54 cm)
- % coverage: not specified
- Type of wrap if used: a nonirritating tape fixed a gauze patch, both covered by an elastic wrap over the trunk and test area, further secured with adhesive tape around the trunk at the cranial and caudal ends

REMOVAL OF TEST SUBSTANCE
- Washing: using gauze moistened with deionized water, followed by dry gauze
- Time after start of exposure: 4 hours

SCORING SYSTEM: Macroscopic Dermal Grading System based on Draize (erythema /edema score).
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours (mean)
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours (mean)
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours (mean)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24, 48, 72 hours (mean)
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24, 48, 72 hours (mean)
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24, 48, 72 hours (mean)
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 (mean, all animals)
Score:
1
Max. score:
4
Remarks on result:
other: Fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hours (mean all animals)
Score:
0
Max. score:
4
Irritant / corrosive response data:
Based on the Regulation (EC) No 1272/2008 (CLP) , the test item is considered to be a nonirritant to the skin of the rabbit based on both, the erythema and edema score.
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
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
Study period:
1999-01-13 to 1999-04-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant Guideline study.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted February 24, 1987
Deviations:
no
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN, USA
- Weight at study initiation: 2.432 g, 2.527 g and 2.704 g (three females)
- Fasting period before study: no
- Housing: individually in suspended stainless steel cages
- Diet: PPMI Certified Rabbit Chow #5322 (Purina Mills, Inc.) ad libitum
- Water: municipal tap water treated by reverse osmosis ad libitum
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature: 18°C to 22°C
- Humidity: 26-46 %
- Air changes: 10 to 15 air changes per hour
- Photoperiod: 12-hour light / 12-hour dark cycle

IN-LIFE DATES: From: 1999-01-29 To: 1999-02-08
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL (determined to be 0.0270 g of processed test item)

Duration of treatment / exposure:
single treatment
Observation period (in vivo):
1, 24, 48 and 72 hours and up to 10 days after dosing
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the treated eyes were not washed after instillation

SCORING SYSTEM:
Ocular Grading System based on Draize. EEC Ocular Scores (Corneal Opacity, Iris Lesions, Conjunctival Redness, Conjunctival Edema)

TOOL USED TO ASSESS SCORE: fluorescein
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 10 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(all animals)
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
Based on the EEC Eye Irritation Evaluation Criteria, the test item is considered to be a nonirritant to the eye of the rabbit.
Interpretation of results:
not irritating
Remarks:
Migrated information 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

Skin irritation/corrosion

The potential irritant and/or corrosive effects of the test item were evaluated in a study according to OECD TG 404 on the skin of New Zealand White rabbits. Each of six rabbits received a 0.5 g dose of the test article as a single dermal application. Each test site was moistened with deionised water to enhance test article contact with the skin. The dose was held in contact with the skin under a semi-occlusive binder for an exposure period of four hours. Following the exposure period, the binder was removed and the remaining test article was wiped from the skin using gauze moistened with deionised water followed by dry gauze. Test sites were subsequently examined and scored for dermal irritation for up to 7 days following patch removal. Exposure to the test article produced very slight to well-defined erythema on 6/6 sites at the 1-hour scoring interval. The dermal irritation resolved completely in all animals by study day 7. Under the conditions of this test, the test item is considered to be a slight irritant to the skin of the rabbit. Based on the criteria laid down in Regulation (EC) No 1272/2008 (CLP), the test item is considered to be a nonirritant to the skin of the rabbit based on both, the erythema and edema score. The Mean Irritation Indices for erythema and edema were 1 and 0.00, respectively.

 

Eye irritation

The potential irritant and/or corrosive effects of the test item were evaluated on the eyes of New Zealand White rabbits in a study according to OECD TG 405. Each of three rabbits received a 0.0270 g (0.1 mL weight equivalent) dose of the test article in the conjunctival sac of the right eye. The contralateral eye of each animal remained untreated and served as a control. Test and control eyes were examined for signs of irritation for up to 10 days following dosing. Exposure to the test article produced conjunctivitis (redness, swelling and/or discharge) in 3/3 test eyes at the 1-hour scoring interval. The individual conjunctivae score were reported as follows: animal 1 score 1 fully reversible within 10 days, for animal 2 score 0.67 fully reversible within 72h and for animal 3 score 0.67 fully reversible within 72h. Based on the criteria laid down in Regulation (EC) No 1272/2008 (CLP), the test item is considered to be a nonirritant to the ocular tissue of the rabbit.


Justification for selection of skin irritation / corrosion endpoint:
Only one GLP and guideline compliant study available.

Justification for selection of eye irritation endpoint:
Only one GLP and guideline compliant study available.

Justification for classification or non-classification

Based on the results of the skin irritation study the test item is not subjected to classification and labelling for skin irritating effects according to Directive 67/548/EEC and Regulation (EC) No 1272/2008.

Based on the results of the eye irritation study the test item is not subjected to classification and labelling for eye irritation effects according to Directive 67/548/EEC and Regulation (EC) No 1272/2008.