Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Sex:
male/female
Details on test animals 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 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 substances and substances containing the same groups, 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 dyes of this class have acute toxicity discriminating dose > 2000 mg/kg and the similar substances reviewed fall into this category.

 

There is limited evidence that this type of substance is significantly absorbed by dermal contact due to the high molecular weight. Assessments of smaller molecules containing the same functional groups suggest low dermal toxicity.

 

It is not considered justifiable to perform further acute oral toxicity testing on CR SB32N2 in view of the similarity with other dyes assessed in this report.