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Diss Factsheets

Administrative data

Description of key information

The test substance is non-irritant to rabbit skin and eyes.

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:
03 October 1974
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
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
Species:
rabbit
Strain:
other: Russian breed
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs
- Diet: (NAFAG, Gossau SG, rabbit food ad libitum.
- Water: ad libitum
Type of coverage:
occlusive
Preparation of test site:
shaved
Remarks:
electric clipper
Vehicle:
other: 50 % polyethylene glycol trituration (PEG 400)
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 h
Observation period:
24 and 72 h
Number of animals:
3 male and 3 female
Irritation parameter:
erythema score
Remarks:
intact and scarified skin
Basis:
mean
Remarks:
6 animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
intact and scarified skin
Basis:
mean
Remarks:
6 animal
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
6 anaimal
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Non irritant.
Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20044/A is non-irritant to rabbit skin.
Executive summary:

The purpose of this test with FAT 20044/A was 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 breed were used in the study. FAT 20044/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it, based on the evaluation scheme. The erythema and edema score in all the animals was '0', so based on the study results, FAT 20044/A is non-irritant to rabbit skin.

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:
03 October 1974
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to guideline
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
Species:
rabbit
Strain:
other: Russian breed
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing:
separately in V2A wire mesh cages
- Diet: NAFAG, Gossau SG, rabbit food and water ad libitum.
- Water: ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
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.
Observation period (in vivo):
24 hours and after 2, 3, 4 and 7 days
Number of animals or in vitro replicates:
3 male and 3 female
Irritation parameter:
cornea opacity score
Remarks:
Eyes rinsed and unrinsed
Basis:
mean
Remarks:
6 animal
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 unrinsed
Basis:
mean
Remarks:
6 animal
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 unrinsed
Basis:
mean
Remarks:
6 animal
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 animal
Time point:
24/48/72 h
Remarks on result:
not measured/tested
Irritant / corrosive response data:
The test substance is non-irritant to the eye of rabbits.
Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20044/A is non-irritant to the eye of rabbits.
Executive summary:

An acute eye irritation study was carried out with FAT 20044/A according to Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) of the US Association of Food and Drug Officials (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, 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 irritation score was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae. Therefore, FAT 20044/A is to be considered as non-irritant to the eye of rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In-vivo Skin Irritation:


The purpose of this test with FAT 20044/A was 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 breed were used in the study. FAT 20044/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it, on the basis of the following evaluation scheme. The erythema and edema score in all the animals was '0', so based on the study results, FAT 20044/A is non-irritant to rabbit skin.


 


In-vivo Eye Irritation:


An acute eye irritation study was carried out with FAT 20044/A according to Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) of the US Association of Food and Drug Officials (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, 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 irritation score was found to be 0 for the cornea, 0 for the iris and 0 for the conjunctivae. Therefore FAT 20044/A is to be considered as non-irritant to the eye of rabbits.

Justification for classification or non-classification

Based on the findings in the skin and eye irritation study, the test substance does not considered to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 to be irritating to the skin as well as eyes.