Registration Dossier
Registration Dossier
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EC number: 425-620-2 | CAS number: -
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- Wistar
Administration / exposure
- Route of administration:
- oral: gavage
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- ca. 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- changes in number of pregnant
- changes in pregnancy duration
- clinical signs
- dead fetuses
- early or late resorptions
- effects on pregnancy duration
- food consumption and compound intake
- gross pathology
- histopathology: neoplastic
- histopathology: non-neoplastic
- maternal abnormalities
- mortality
- necropsy findings
- number of abortions
- ophthalmological examination
- pre and post implantation loss
- total litter losses by resorption
Maternal abnormalities
- Abnormalities:
- no effects observed
Results (fetuses)
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- ca. 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reduction in number of live offspring
- changes in sex ratio
- fetal/pup body weight changes
- changes in litter size and weights
- external malformations
- skeletal malformations
- visceral malformations
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- no
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.
