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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:
May 1974
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Data is from experimental report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 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).
Principles of method if other than guideline:
The skin irritation study of test chemical was conducted in Russian breed rabbits.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts
EC Number:
235-468-7
EC Name:
Ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts
Cas Number:
12237-62-6
Molecular formula:
[C24N3H28] Cu2Fe(CN)6
IUPAC Name:
ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts
Test material form:
solid
Details on test material:
IUPAC name: ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts
Substance type: Organic
Physical state: Solid
Molecular Formula: [C24N3H28] Cu2Fe(CN)6
Molecular Weight: 697.54 g/mol

Test animals

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Six rabbits (3 males/3 females) of the Russian breed
- Weight at study initiation: 1.5 to 2 kgs
- Housing: V2A wire cages
- Diet (e.g. ad libitum): food (NAFAG, Gossau SG, rabbit food)
- Water (e.g. ad libitum): water ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g (500mg)
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6 (3 males/3 females)
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage: 2.5*2.5 cm
- Type of wrap if used: 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.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data available
- Time after start of exposure: no data available

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : The reaction of the skin was appraised upon removal and 72 hours after it.

SCORING SYSTEM:
- Method of calculation: 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.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
8
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Not Irritating to skin
Other effects:
No Data Available

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
The primary irritation index as the measure of the acute irritation to the skin of rabbits was observed to be 0. Therefore the test chemical can be considered as non-irritant to the skin of rabbits.
Executive summary:

The skin irritation study of test chemical was conducted in Russian breed rabbits. 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. 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 test chemical was applied to each side in quantities of 0.5 g (500mg). 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. The primary irritation index as the measure of the acute skin irritation provoked by the substance was 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 test chemical was evaluated to be 0.0 out of maximum score of 8. Since the treated rabbits did not develop any signs of skin irritation, the test chemical was considered to be not irritating to the skin.