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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
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:
not specified
Principles of method if other than guideline:
Irritation potency of FAT 40062/A in the rabbit eyes of both sexes observed over a period of 7 days by treating with 0.1 g of the test substance.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Details on test material:
- Name of test material (as cited in study report): FAT 40062/A

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Huntsman/ Ciba-Geigy
- Housing: Kept separately in V2A wire mesh cages
- Diet: NAFAG, Gossau SG (Rabbit food) ad libitum
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 males / 3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 10 ml lukewarm water
- Time after start of exposure: 30 seconds

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
Eyes rinsed and eyes not rinsed
Basis:
mean
Remarks:
6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Remarks:
Eyes rinsed and eyes not rinsed
Basis:
mean
Remarks:
6 rabbitts
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
Eyes rinsed and eyes not rinsed
Basis:
mean
Remarks:
6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The irritation index was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40062/A is to be considered as non-irritant to the eye of rabbits.
Executive summary:

FAT 40062/A, was evaluated for primary eye irritation after instillation of 0.1 g of the test substance into the conjunctival sac of the left eye of 6 rabbits (3 males/ 3 females) of the Russian breed, which were kept separately in V2A wire mesh cages. After application, the eyelids were held open for a few seconds. The right eye served as a control. Only rabbits showing normal ophthalmic findings were included in the test. The eyes of 3 of these 6 rabbits were rinsed with 10 ml of lukewarm water about 30 seconds after treatment. The treated eyes of all animals (washed and unwashed) were evaluated after 24 h 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 for the conjunctivae.

Therefore, FAT 40062/A is to be considered as non-irritant to the eye of rabbits.