Registration Dossier

Administrative data

Description of key information

FAT 40061/A is considered to be non- irritant to the skin and eyes of rabbits.

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:
1974
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:
yes
Remarks:
occlusive testing conditions applied
GLP compliance:
no
Species:
rabbit
Strain:
other: Russian breed
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Russian breed
- Weight at study initiation: 1.5 to 2 kgs
- Housing: Separately in V2A wire cages.
- Diet: NAFAG, Gossau SG, rabbit food ad libitum
- Water: ad libitum
Type of coverage:
occlusive
Preparation of test site:
shaved
Remarks:
As well as sacrificed skin
Vehicle:
other: 50 % polyethylene glycol trituration (PEG 400)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
FAT 40061/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made.
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
3 males and 3 females
Details on study design:
Six rabbits (3 males/3 females) of the Russian breed, weighing 1.5 to 2 kgs,were shaved on the whole back and flanks two days before treatment with an electric clipper. In order to prevent injuries by bites the rabbits were kept separately in V2A wire cages, where they had access to food (NAFAG, Gossau SG, rabbit food) and water ad libitum. 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. FAT 40061/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 following evaluation scheme.

Evaluation of Skin Reactions

Erythema and eschar formation
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)
 
Edema formation
0: No edema
1: Very slight edema (barely perceptible)
2: Slight edema (edges of area well defined by definite raising)
3: Moderate edema (raised approximately 1 mm)
4: Severe edema (raised more than 1 mm and extending beyond area of exposure)
Irritation parameter:
erythema 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:
edema 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

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. Compounds producing combined averages (primary irritation indexes) of 2 or less are only mildly irritating; whereas those with indexes from 2 to 5 are moderate irritants, and those with scores above 6 are considered severe irritants. The primary irritation index of FAT 40061/A was 0.

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40061/A is to be considered as non-irritant to the skin of rabbits.
Executive summary:

A study was conducted to assess the potential of FAT 40061/A to cause acute irritation on the rabbit skin. 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 occlusive patch test. The rabbits were shaved on the whole back and flanks two days before treatment with an electric clipper. In order to prevent injuries by bites the rabbits were kept separately in V2A wire cages, where they had access to food (NAFAG, Gossau SG, rabbit food) and water ad libitum. 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. FAT 40061/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 2 4 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0. Therefore, FAT 40061/A is to be considered as non-irritant to the skin of rabbits.

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:
1974
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:
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 cages and fed on NAFAG, Gossau SG.
- Diet: ad libitum
- Water: ad libitum
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
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.

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

 

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.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin:

A study was conducted to assess the potential of FAT 40061/A to cause irritation on the rabbit skin. 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 occlusive patch test. The rabbits were shaved on the whole back and flanks two days before treatment with an electric clipper. In order to prevent injuries by bites the rabbits were kept separately in V2A wire cages, where they had access to food (NAFAG, Gossau SG, rabbit food) and water ad libitum. 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. FAT 40061/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 2 4 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0. Therefore FAT 40061/A is to be considered as non-irritant to the skin of rabbits.

Eye:

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 48 h. 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.

Justification for classification or non-classification

Based on the above stated assessment of the skin and eye irritation potential, the substance does not have to be classified for irritation according to CLP (Regulation (EC) No 1272/2008 of the European parliament and of the Council.