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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:
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
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
None

Test animals / tissue source

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: separately in V2A wire cages and fed on NAFAG, Gossau SG.
- Diet: ad libitum
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g

Duration of treatment / exposure:
One application
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6 rabbits (3 males and 3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): 30 seconds after treatment
- Time after start of exposure: after 24 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
24/48/72 h
Score:
0.17
Max. score:
3
Reversibility:
fully reversible within: 48h
Remarks on result:
other: Animal no. 4 and 5 whose eyes were not rinsed after exposure had slight irritation at 24h observsation.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 males and 3 females
Time point:
24/48/72 h
Score:
0.11
Max. score:
4
Reversibility:
fully reversible within: 48h
Remarks on result:
other: Animal no. 4 and 5 whose eyes were not rinsed after exposure had slight irritation at 24h observsation.
Other effects:
No other effects reported.

Any other information on results incl. tables

The irritation index was found to be 0 for the cornea, 0 for the iris and 0.5 for the conjunctivae.

Evaluation of the Eye Reactions

Eyes rinsed:

Animal No

Observation time (Hr)

Cornea

Iris

 Conjunctivae

Rabbit 1

24

0

0

 0

48

0

0

 0

72

0

0

 0

Rabbit 2

24

0

0

 0

48

0

0

 0

72

0

0

 0

Rabbit 3

24

0

0

 0

48

0

0

 0

72

0

0

 0

 

Eyes not rinsed:

Animal No

Observation time (Hr)

Cornea

Iris

 Conjunctivae

Rabbit 4

24

0

0

 6

48

0

0

 0

72

0

0

 0

Rabbit 5

24

0

0

 8

48

0

0

 0

72

0

0

 0

Rabbit 6

24

0

0

 0

48

0

0

 0

72

0

0

 0

 

Applicant's summary and conclusion

Interpretation of results:
Category 2B (mildly irritating to eyes) based on GHS criteria
Conclusions:
FAT 40061 is considered to be as a minimal irritant to the eye of rabbits.
Executive summary:

To assess the acute eye irritation potential of FAT 40061 when exposed to rabbit eye, a study was performed in accordance to the procedure mentioned in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (19 59) of the AFDO. The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed. Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, their 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. Animal no. 4 and 5 whose eyes were not rinsed after exposure had slight irritation with conjunctiva at 24h observsation, which got reversed by 48h. No other irritation reactions were seen. 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 0.5 for the conjunctivae. Therefore FAT 40061/A is considered to be as a minimal irritant to the eye of rabbits.