Registration Dossier

Administrative data

Description of key information

The test substance was not irritating to rabbit skin and minimally irritating to the rabbit 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:
1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adult animals
- Weight at study initiation: about 3 kg
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days
Type of coverage:
occlusive
Preparation of test site:
other: one test site on each animal shaved, the other test site shaved and abraded
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: 0.5 g test substance moistened with 0.5 mL of water

VEHICLE
- Amount applied: 0.5 mL water
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
4 (2 males and 2 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm * 2.5 cm each of the two application sites

- Type of wrap if used: Gauze patches containing test material were secured by thin strips of adhesive tape, the entire trunk was wrapped with impervious plastic sheeting securely taped in place.

SCORING SYSTEM: according to Draize
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h / 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h / 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No dermal reactions at any timepoint.
Interpretation of results:
GHS criteria not met
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:
1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: Federal Hazardous Substances Labeling Act (1964)
Deviations:
no
GLP compliance:
no
Species:
rabbit
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg
Duration of treatment / exposure:
directly after application, the eyelids were held together for a second and eyes were not washed out afterwards
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6 (3 males, 3 females)
Details on study design:
SCORING SYSTEM:
according to "Illustrated Guide for Grading Eye Irritation by Hazardous Substances", issued by the Superintendent of Documents, Govemment Printing Office, Washington, D.C.
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 h /48 h / 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 h /48 h / 72 h
Score:
0.05
Max. score:
2
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h /48 h / 72 h
Score:
< 0.16
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h /48 h / 72 h
Score:
< 0.11
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
After 24 hours, minimal redness and chemosis were observed in three and two animals, respectively. In addition, one animal showed minimal reaction of the iris with a score of 1 after 24 hours. All findings cleared after 48 hours.
Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation

To assess the skin irritation potential of the test substance, a study was conducted using 4 young adult rabbits (2 males and 2 females). 24 hours before dermal application, the backs of the rabbits were shaved free of hair with electric clippers, the shaved area constituting about 10 % of the total body surface-area. On each rabbit two test sites, located at the mid-line of the back about 10 centimeters apart, were used. Immediately before application the left-hand site was abraded by making epidermal abrasions, the right-hand site remained intact. Application to each site was in the form of 2.5 cm square gauze patches containing 0.5 g of test material moistened with 0.5 mL of water. These were secured by thin strips of adhesive tape, and the entire trunk wrapped with impervious plastic sheeting securely taped in place. After 24 hours the binders and patches were removed and the sites separately assessed for both erythema and edema on a graded scale of 0 to 4. 72 hours after application a second similar assessment was made. Scores for individual intact and abraided sites were recorded separately for erythema formation and for edema formation at each of the two time intervals. As a result, reactions were neither observed after 24 h nor after 72 hours (mean score erythema formation: 0, mean score edema formation: 0). The test substance therefore did not cause skin irritation under the test conditions chosen.

Eye irritation

An acute eye irritation study was carried out and interpreted in accordance with the Federal Hazardous Substances Labeling Act and published on September 17th, 1964. Six albino rabbits were used (3 males and 3 females), care being taken to protect them from extraneous materials (e.g. sawdust) that might enter the eye. All rabbits were free from observable eye defects. The test material was placed in one eye of each animal by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was dropped. The lids were then gently held together for a second and the animal released. The eyes were examined, and the grade of ocular reaction recorded at 24, 48 and 72 hours. The grades of response were recorded in accordance with those depicted in the "Illustrated Guide for Grading Eye Irritation by Hazardous Substances", issued by the Superintendent of Documents, Government Printing Office, Washington, D.C.. The following mean scores were calculated: cornea score: 0, iris: 0.05, conjunctivae: 0.16, chemosis 0.11. On the basis of these values the test substance is considered to be non-irritating to the rabbits’ eyes.

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 (CLP). As a result the substance is not considered to be classified for skin or eye irritation under Regulation (EC) No 1272/2008.