Disodium [N-[7-hydroxy-8-[(2-hydroxy-5-mesylphenyl)azo]-1-naphthyl]acetamidato(2-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(2-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

Justification for read across is detailed in the report attached to the IUCLID section 13.

Cross-reference

Reason / purpose for cross-reference:

read-across source

Reference

Endpoint:

skin irritation / corrosion, other

Remarks:

points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

Justification for read across is detailed in the report attached to the IUCLID section 13.

Reason / purpose for cross-reference:

read-across source

Qualifier:

no guideline available

Principles of method if other than guideline:

None

GLP compliance:

no

Specific details on test material used for the study:

None

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

None

Type of coverage:

semiocclusive

Preparation of test site:

other: abraded and intact

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.5 g of the solid was mixed to a paste with 0.5 ml of water before application to each treatment site.

Duration of treatment / exposure:

None

Observation period:

24 hours

Number of animals:

6 animals

Details on study design:

None

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Irritant / corrosive response data:

There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings .

Other effects:

None

None

Interpretation of results:

other: not classified

Remarks:

Classification criteria according to the CLP Regulation 1272/2008 and its amendments

Conclusions:

Non-irritant to the skin of rabbits.

Executive summary:

A study was performed to determine the acute irritation, provoked by the Similar substance 01, on the skin of the rabbits according to the procedure employed was that prescribed by The Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 & 191 .11).

6 rabbits (3 males and 3 females), Albino White breed, were shaved and the test substance applied on abraded and intact skin of the animals. 0.5 g of the solid was mixed to a paste with 0.5ml of water before application to each treatment site. The animals were immobilized with patches secured in place by adhesive tape. The entire trunk of the animal was then wrapped with an impervious material such as rubberized cloth for the 24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances. After 24 hours exposure, the patches were removed and the resulting reactions were evaluated. There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings. Therefore the similar substance 01 is to be considered as a non-irritant to the skin of rabbits.

 

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

None

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Similar substance 01 of Acid Black 213

IUPAC Name:

Similar substance 01 of Acid Black 213

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

None

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

None

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: abraded and intact

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.5 g of the solid was mixed to a paste with 0.5 ml of water before application to each treatment site.

Duration of treatment / exposure:

None

Observation period:

24 hours

Number of animals:

6 animals

Details on study design:

None

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

0

Irritant / corrosive response data:

There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings .

Other effects:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

Classification criteria according to the CLP Regulation 1272/2008 and its amendments

Conclusions:

Non-irritant to the skin of rabbits.

Executive summary:

A study was performed to determine the acute irritation, provoked by the Similar substance 01, on the skin of the rabbits according to the procedure employed was that prescribed by The Food and Drug Administration of the U.S.A. in The Federal Register (17 September 1964 & 191 .11).

6 rabbits (3 males and 3 females), Albino White breed, were shaved and the test substance applied on abraded and intact skin of the animals. 0.5 g of the solid was mixed to a paste with 0.5ml of water before application to each treatment site. The animals were immobilized with patches secured in place by adhesive tape. The entire trunk of the animal was then wrapped with an impervious material such as rubberized cloth for the 24-hour period of exposure. This material aids in maintaining the test patches in position and retards the evaporation of volatile substances. After 24 hours exposure, the patches were removed and the resulting reactions were evaluated. There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings. Therefore the similar substance 01 is to be considered as a non-irritant to the skin of rabbits.