2-{[4-({4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfo-1-naphthyl}diazenyl)-(6 or 7)-sulfo-1-naphthyl]diazenyl}benzene-1,4-disulfonic acid, lithium sodium salts

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

2016

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Based on reliable review of literature and assessment of similar sulphonated azo dyes. No further animal testing is justified.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Principles of method if other than guideline:

Methods not always explicit in reviews, but OECD testing principles appear to have been followed in most cases.

GLP compliance:

not specified

Test type:

other: Review of various studies

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sulphonated azo dyes

IUPAC Name:

Sulphonated azo dyes

Test animals

Species:

rat

Sex:

male/female

Details on test animals or test system and environmental conditions:

Mostly rat data, but dermal effects on guinea pigs and rabbits also examined (non-maximised sensitisation studies and dermal irritation)

Administration / exposure

Type of coverage:

not specified

Vehicle:

not specified

Doses:

Up to 2000 mg/kg

Control animals:

not specified

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality reported

Clinical signs:

other: Other than discolouration, no clinical signs

Gross pathology:

No adverse systemic effects reported.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on reliable review of literature and assessment of similar sulphonated azo dyes.
No further animal testing is justified.

Executive summary:

From assessment of similar sulphonated azo dyes, none are noted as being acutely toxic and there is no evidence of dermal absorption. From various data sources, it is considered unlikely that the substance will be acutely toxic by the dermal route. Most azo dyes have acute toxicity discriminating dose > 2000 mg/kg and the similar substances reviewed fall into this category.

 

The impact of lithium is not likely to impact on the toxicity when comparing with sodium salts as dermal toxicity of lithium substances are reported to be low and in view of the minimal % w/w content of lithium, this is not significant in the classification of toxicity.

 

Studies on guinea pigs and rabbits for sensitising and irritancy assessment have not revealed any evidence of adverse systemic effects. Only the maximised sensitising studies (ie injected) appear to give positive results, confirming low levels of dermal absorption. Discolouration of skin will occur and the colour is difficult to wash off.

 

It is not considered justifiable to perform further acute dermal toxicity testing on CJ313 in view of the similarity with other dyes assessed in this report. It should also be noted that some other registrations have indicated waivers for this endpoint.