Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Reference
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
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
Reference
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
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