Registration Dossier

Administrative data

Description of key information

FAT 92348/B is considered to be not an irritant to 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:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Justification for type of information:
None
Qualifier:
according to guideline
Guideline:
other: "Appraisal of the Safety of Chemicals in Poods, Drugs and Cosmetic (1959) of the US Association of Food and Drug Officials (AFDO).
Deviations:
yes
Remarks:
occlusive testing conditions, abraded testing conditions used
Principles of method if other than guideline:
Guideline followed
GLP compliance:
no
Specific details on test material used for the study:
None
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,
- Housing: kept separately in V2A wire mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
not specified
Controls:
no
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
24 hr
Observation period:
72 hr
Number of animals:
6 (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: back and flanks
- % coverage: gauze patch size was 2.5 x 2.5 cm
- Type of wrap if used: patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: 24 hr
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hr
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hr
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Remarks:
No effects observed
Remarks on result:
other: animal 4 & 5 showed edima score 1 on sacrified skin. The effects were full reversable at the end of 72 hr
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hr
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hr
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritant / corrosive response data:
All animals except animal #4 and #5 showed no effects. Animal 4 & 5 showed edema score 1 on sacrified skin. The effects were fully reversible after 72 hrs. The primary irritation index of FAT 40065/A was 0.1.
Other effects:
None

Table 1: Skin irritation – individual scores

Animal No.

Sex

Skin reaction

2 4 h after application

72 h after application

intact skin

scarified skin

intact skin

scarified skin

1

female

erythema

0

0

0

0

edema

0

0

0

0

2

female

erythema

0

0

0

0

edema

0

0

0

0

3

female

erythema

0

0

0

0

edema

0

0

0

0

4

male

erythema

0

0

0

0

edema

0

1

0

0

5

male

erythema

0

0

0

0

edema

0

1

0

0

6

male

erythema

0

0

0

0

edema

0

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40065/A is considered to be not a skin irritant.
Executive summary:

The purpose of this test was to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by test substance FAT 40065/A 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, 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 mesh 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 40065/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 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 as the measure of the acute irritation to the skin of rabbits was found to be 0.1. Rabbit # 4 and 5 had only observation of edema scored as 1 at 24 h observation, which was found to reverse at 72 h observation. No other findings were recorded. Hence, the scoring does not meet the threshold scores for classification as proposed by Regulation EC No. 1272/2008. Hence, FAT 40065/A is considered to be not a skin irritant.

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
Justification for type of information:
None
Qualifier:
according to guideline
Guideline:
other: "Appraisal of the Safety of Chemicals in Poods, Drugs and Cosmetic (1959) of the US Association of Food and Drug Officials (AFDO).
Principles of method if other than guideline:
Guideline followed
GLP compliance:
no
Specific details on test material used for the study:
None
Species:
rabbit
Strain:
other: Russian breed,
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: kept separately in V2A wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right eye served as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g
Duration of treatment / exposure:
The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.
Observation period (in vivo):
24 hours and after 2, 3, 4 and 7 days
Number of animals or in vitro replicates:
6 rabbits (3 males/3 females)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.
- Time after start of exposure: 24 hr, 2 day, 3 day, 4day and 7 day

SCORING SYSTEM:

TOOL USED TO ASSESS SCORE: hand-slit lamp
Irritation parameter:
cornea opacity score
Remarks:
irritation index for cornea
Basis:
mean
Time point:
7 d
Score:
0
Irritation parameter:
iris score
Remarks:
irritation index for iris
Basis:
mean
Time point:
7 d
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
irritation index for conjunctivae
Basis:
mean
Time point:
7 d
Score:
2.5
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
The irritation index was found to be 0 for the cornea, 0 for the iris and 2.5 for the conjunctivae.
Other effects:
None

Table 1: Eye irritation – individual scores (eyes rinsed)

Days after appl.

Rabbit 1 (male)

Rabbit 2 (male)

Rabbit 3 (male)

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

1

0

0

0

0

0

8

0

0

0

2

0

0

0

0

0

6

0

0

0

3

0

0

0

0

0

0

0

0

0

4

0

0

0

0

0

0

0

0

0

7

0

0

0

0

0

0

0

0

0

 

Table 2: Eye irritation – individual scores (eyes not rinsed)

Days after appl.

Rabbit 4 (female)

Rabbit 5 (female)

Rabbit 6 (female)

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

Cornea

Iris

Conjunctiva

1

0

0

12

0

0

12

0

0

12

2

0

0

8

0

0

10

0

0

8

3

0

0

0

0

0

0

0

0

0

4

0

0

0

0

0

0

0

0

0

7

0

0

0

0

0

0

0

0

0

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40065/A is considered to be not an eye irritant.
Executive summary:

FAT 40065/A was subjected to eye irritation test. 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). The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed, which were kept separately in V2A wire mesh cages and fed on NAFAG, Gossau SG, rabbit food and water ad libitum. Only rabbits showing normal ophthalmic findings were included in the test.

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 2.5 for the conjunctivae. Therefore FAT 40065/A is to be considered as a minimal irritant to the eye of rabbits. However the scoring does not meet the threshold scores for classification as proposed by Regulation EC No. 1272/2008. Hence, FAT 40065/A is considered to be not an eye irritant.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation:

FAT 40065/A was tested for the primary-irritation on the skin of the rabbits using the 0.5 g concentration. 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 as the measure of the acute irritation to the skin of rabbits was found to be 0.1. Therefore FAT 40063/A is to be considered as a mild irritant to the skin of rabbits. Nevertheless, according to today’s standards, results from tests performed on the abraded skin should not be taken into account for hazard assessment. Therefore based on the results available on the intact skin the substance is considered as not irritant.

Eye irritation:

FAT 40065/A was subjected to eye irritation test. 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). The substance was tested on 6 rabbits (3 males/3 females). Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. 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 2.5 for the conjunctivae. However the scoring does not meet the threshold scores for classification as proposed by Regulation (EC) No. 1272/2008. Hence, FAT 40065/A is considered to be not an eye irritant.

Justification for classification or non-classification

Based on the available data, substance is considered as not to be an irritant to skin and eyes. Hence, the results do not warrant classification according to EU CLP.