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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Justification for type of information:
data is from experimental reports

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

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).
Principles of method if other than guideline:
To measure of the acute irritation provoked by the test chemical on the skin of the rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- IUPAC name: Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts
- Common name: C.I. Pigment Red 169
- Molecular formula: C62H58Cu3FeN10O6
- Substance type:Organic
- Physical state: Solid

Test animals

Species:
rabbit
Strain:
other: Russian breed
Details on test animals and environmental conditions:
TEST ANIMALS
- Sex: Male/female
- Weight at study initiation: 1.5 to 2 kgs
- Housing: In order to prevent injuries by bites the rabbits were kept separately in V2A wire cages.
- Diet (e.g. ad libitum): food (NAFAG, Gossau SG, rabbit food) ad libitum
- Water (e.g. ad libitum): ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
C.I. Pigment Red 169 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:
24 hrs and 72 hrs
Number of animals:
Six rabbits (3 males/3 females)
Details on study design:
PROCEDURE:
Six rabbits (3 males/3 females) of the Russian breed were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment.

TEST SITE
- Area of exposure: A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin
- Type of wrap if used: The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.

REMOVAL OF TEST SUBSTANCE
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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The primary irritation index of C.I. Pigment Red 169 was 0.

Any other information on results incl. tables

Evaluation of Skin reactions:

Animal number, sex

Skin reaction

24 hours after application

72 hours after application

Intact skin

Scarified skin

Intact skin

Scarified skin

1, male

Erythema

 

 

 

 

Edema

 

 

 

 

2, male

Erythema

0

0

0

0

Edema

0

0

0

0

3, male

Erythema

0

0

0

0

Edema

0

0

0

0

4, female

Erythema

0

0

0

0

Edema

0

0

0

0

5, female

Erythema

0

0

0

0

Edema

0

0

0

0

6, female

Erythema

0

0

0

0

Edema

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Conclusions:
The Primary Irritation Index of test chemical was 0. Hence, the test chemical can be considered to be not irritating to rabbit skin.
Executive summary:

The purpose of the test was to determine the primary-irritation index, which serves as a reassure of the acute irritation, provoked by test chemical 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" (19 59) of the US Association of Food and Drug Officials (AFDO). Six rabbits (3 males/3 females) of the Russian breed, were shaved on the whole back and flanks two days before treatment with an electric clipper. 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. The chemical was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The patch was kept intact till 24 hours. The reaction of the skin was appraised upon removal and 72 hours after patch removal. The observed reactions were scored and Primary Irritation Index was calculated. The Primary Irritation Index of test chemical was 0. Hence, the test chemical can be considered to be not irritating to rabbit skin.