Registration Dossier
Registration Dossier
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EC number: 234-204-8 | CAS number: 10595-49-0
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- Study period:
- Study planned to start within 6 months of final confirmation from ECHA
- 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 : 3-Lauramidopropyl trimethyl ammonium methyl sulfate
- Name of the substance for which the testing proposal will be used: 3-Lauramidopropyl trimethyl ammonium methyl sulfate
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies : None available
- Available non-GLP studies : None available
- Historical human data : None available
- (Q)SAR : Not sufficiently robust for developmental toxicity
- In vitro methods : Not sufficiently robust for developmental toxicity
- Weight of evidence : No developmental toxicity studies available
- Grouping and read-across : It has not been possible to identify suitable studies on suitable source substances
- 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:
- No suitable adaption possibllities available
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: OECD 414 study in the rat
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate
- EC Number:
- 234-204-8
- EC Name:
- Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate
- Cas Number:
- 10595-49-0
- Molecular formula:
- C19H42N2O5S
- IUPAC Name:
- 3-(dodecanoylamino)-N,N,N-trimethylpropan-1-aminium methyl sulfate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: gavage
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.
