Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
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 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Various methods are reporting, but most data is from historical LD50 work although the discriminating dose has been possible to determine.
GLP compliance:
not specified
Test type:
other: Review of various methods
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Doses:
Dose levels up to 5000 mg/kg are reported for some substances

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
> 2 000 mg/kg bw
Based on:
other: estimation
Mortality:
No mortality noted in any of the substances reviewed at dose levels up to 2000 mg/kg
Clinical signs:
Other than post-dosing distress (excessive grooming, subdued behaviour etc) the main clinical sign has been discolouration of the animals
This may in part be due to urine or feaces, but longer term studies confirm absorption and discolouration of skin not due to grooming.
Body weight:
No effects noted
Gross pathology:
Discolouration noted. Liver effects reports in some cases, but these may be adaptive.
Other findings:
Discolouration

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Review of similar substances and publications relating to azo dyes, concluded low oral toxicity
No further animal testing can be justified.
Executive summary:

From assessment of similar sulphonated azo dyes, none are noted as being acutely toxic. From various data sources, it is considered unlikely that the substance will be acutely toxic. 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 as the w/w content of lithium is not significant in the classification of toxicity.

 

There is evidence that the substance is absorbed by ingestion and there are many publications relating to possible metabolic processes [ref]. Discolouration of whole animals is regularly reported suggesting absorption and distribution.

 

Although not full assessed for this low-volume registration, longer term studies have also been reviewed and adverse effects (mainly liver and kidneys) are seen in many azo dyes. However, none of the specific substances reviewed are classified as STOT RE as the adverse effect levels are above threshold for classification. There is also some debate as to whether the liver changes are adaptive and recovery will occur or whether these are ‘adverse’.

 

It is not considered justifiable to perform further acute oral toxicity testing on CJ308 in view of the similarity with other dyes assessed in this report.

Ref: Azo Dyes and Their Metabolites,Farah Maria Drumond Chequer et al, Intechopen.com