Registration Dossier

Administrative data

Description of key information

The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.Therefore the test subsatnce is to be considered as non-irritant to the skin of rabbits.

The primary-irritation index, which serves as a measure of the acute eye irritation, was found to be 0 for the cornea, 0 for the iris and 0.2 for the conjunctivae. The findings were reversible within 2 days.

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Qualifier:
according to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2-3 kg
- Housing: single housing in V2A wire cages
- Diet: NAFAG (Gossau SG, rabbit food), ad libitum
- Water: ad libitum
Type of coverage:
occlusive
Preparation of test site:
other: shaved and slightly scarified on the left side
Vehicle:
other: Polyethylene glycol (PEG 400)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
- Concentration: 50 % polyethylene glycol suspension
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6 (3 males / 3 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5*2.5 cm (on both sides)
- Type of wrap if used: The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h and 72 h after application
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h and 72 h after application
Score:
0
Max. score:
4
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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Species:
rabbit
Strain:
other: Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: single housing in V2A wire cages
- Diet: NAFAG (Gossau SG) rabbit food ad libitum
- Water: ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 g
Duration of treatment / exposure:
single treatment (30 seconds)
Observation period (in vivo):
The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days.
Number of animals or in vitro replicates:
3 males, 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The treated eyes of three rabbits were each rinsed with 10 mL lukewarm water about 30 seconds after treatment.

SCORING SYSTEM:
on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO.

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: days 1,2,3,4,7 after application
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
other: days 1,2,3,4,7 after application
Score:
0
Max. score:
10
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: days 1,2,3,4,7 after application
Score:
0.2
Max. score:
20
Reversibility:
fully reversible within: 48 h
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

The skin irritation/corrosion potential of the test substance was assessed in an equivalent to OECD 404 study. The test was conducted to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound on the skin of the rabbits. The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Six rabbits (3 males/3 females) of the Russian strain were shaved on the whole back and flanks two days before treatment with an electric clipper.

The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. The test substance was-applied to each side in quantities of 0.5 g. Before application a 50% polyethylene glycol suspension (PEG 400) was made. The gauze patches were removed 24 hours after the application. The primary irritation index as the measure of the acute skin irritation provoked by the substance is defined as the average of all the ratings found after 24 and 72 hours on the intact and slightly scarified skin. The erythema and edema score was 0, respectively.

Additionally, the potential of the test substance to induce eye irritation was determined in a study equivalent to OECD 405. The substance was tested for its irritating effect on the eyes of 6 rabbits (3 males/3 females) of the Russian strain. The procedure adopted was the technique described in the"Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 mL lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO. The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 0 for the cornea, 0 for the iris and 0.2 for the conjunctivae. The findings were reversible within 2 days.

Justification for classification or non-classification

Based on the available information classification for skin or eye irritation is not warranted in accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation No. 1272/2008.