Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

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

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 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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid
Specific details on test material used for the study:
None

Test animals

Species:
rabbit
Strain:
other: Russian breed,
Details on test animals 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

Test system

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

Results and discussion

In vivo

Resultsopen allclose all
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

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.