Registration Dossier
Registration Dossier
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EC number: 403-530-4 | CAS number: 129423-54-7 PV-ECHTGELB HGR
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out
Pigment Yellow 191 nanoform
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies:
there are no valid studies available on this endpoint
- Available non-GLP studies:
there are no valid studies available on this endpoint
- Historical human/control data:
No data available for this endpoint
- (Q)SAR:
Pigments are outside the applicability domain of models
- In vitro methods:
No method available for this endpoint
- Weight of evidence
- Grouping and read-across:
there are no data available for this type of pigment
- Substance-tailored exposure driven testing :
No method available for this endpoint
- Approaches in addition to above:
No method available for this endpoint
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:
- There are no data available fit for a valid read across, weight of evidence, or category approach. Exposure cannot be excluded for workers during production
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Test material form:
- solid: nanoform
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
