Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 304-990-8 | CAS number: 94313-91-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
The reproductive/developmental toxicity screening study is waived in accordance with Annex VIII, 8.7.1 column 2 of the REACH regulation. A testing proposal has been submitted to ECHA for the conduct of a developmental toxicity study on a structurally related substance (methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate; CAS 10595-49-0).
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reproductive effects observed:
- not specified
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
A testing proposal has been submitted to ECHA for an oral developmental toxicity study in rats on a structurally related substance (methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate;
CAS 10595-49-0). The results of this study will be read-across to this substance.Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned (based on read-across)
- Study period:
- Study planned to start within 6 months of final confirmation from ECHA
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
- It should be noted that no new animal testing has been proposed for this substance. A new study on an analogue substance has been proposed and will be used for read-across to this substance when available.
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 3-Lauramidopropyl trimethyl ammonium methyl sulfate (CAS No. 10595-49-0)
- Name of the substance for which the testing proposal will be used: trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate
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 particular compared to the option of read-across from an analogue substance.
- In vitro methods: Not sufficiently robust for developmental toxicity, in particular compared to the option of read-across from an analogue substance.
- Weight of evidence: No developmental toxicity studies available
- Grouping and read-across: A pre-natal developmental toxicity study has already been proposed on an analogue substance (methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate; CAS 10595-49-0) which has already been used as a source substance for read-across. Therefore in order to make maximum use of the proposed study, it will also be used for read-across to this substance.
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable
- Other reasons: 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:
- It should be noted that no new animal testing has been proposed for this substance. A new study on an analogue substance has been proposed and will be used for read-across to this substance when 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 by the oral dose route - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Species:
- rat
- Route of administration:
- oral: gavage
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available (further information necessary)
- Quality of whole database:
- There is a testing proposal for an oral developmental toxicity study in rats on a structurally related substance.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
There is currently no evidence available to indicate that the substance is toxic to reproduction and therefore classification is not justified. A developmental study in the rat by the oral dose route is planned on a structural analogue. When the results are available they will be evaluated and the classification reviewed.
Additional information
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.
