Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
a study according to OECD TG 414 (rat, oral) is planned after approval by ECHA
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS:
A study according to OECD TG 414 (rat, oral) is planned after approval by ECHA

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out:
Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts (UVCB)

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: no studies available
- Available non-GLP studies: no studies available
- Historical human data: no historical human data available
- (Q)SAR: not possible, the substance is a complex mixture of phenazine dyes / Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts (UVCB)
- In vitro methods: A pre-natal developmental toxicity study is a standard information requirement, which cannot currently be replaced by in vitro methods
- Weight of evidence: no studies for a weight of evidence consideration are available
- Grouping and read-across: not possible, the substance is a complex mixture of phenazine dyes / Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts (UVCB)
- Substance-tailored exposure driven testing [if applicable] not applicable
- Approaches in addition to above [if applicable] not applicable
- Other reasons [if applicable] not applicable

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- REACH Annex VIII / IX, column 2 offers possibilities for the omission to perform a prenatal developmental toxicity study. None of the criteria of REACH Annex VIII / IX, column 2 applies. Notably, the substance is not known as a genotoxic carcinogen or germ cell mutagen. Human exposure cannot be excluded. The substance is not known to cause developmental toxicity, meeting the criteria for classification as toxic for reproduction category 1A or 1B (H 360).

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion