Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts

Skin irritation / corrosion

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

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

Test material information

Constituent 1

Reference substance name:

Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts

EC Number:

235-469-2

EC Name:

Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts

Cas Number:

12237-63-7

Molecular formula:

C34H31N8O3Cu3Fe

IUPAC Name:

ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts

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 or test system 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

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Results 2

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.