Registration Dossier
Registration Dossier
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EC number: 953-917-1 | CAS number: -
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- Study period:
- Dependent upon feedback from ECHA
- Justification for type of information:
- Testing proposal:
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out:
Hydrocarbons, C18-C22, n-alkanes, n-alkenes (953-917-1)
- Name of the substance for which the testing proposal will be used [if different from tested substance]- not applicable
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 known GLP developmental toxicity studies of any type available on the substance that fulfills the data requirements.
- Available non-GLP studies- There are no known non-GLP developmental toxicity studies of any type available on the substance that fulfills the data requirements.
- Historical human data- There is no known historical human data for developmental toxicity available on the substance.
- (Q)SAR- There is no known validated (Q)SAR information for developmental toxicity available for this substance.
- In vitro methods- There are no known validated in vitro developmental toxicity methods available for this substance.
- Weight of evidence- Sufficient developmental information is not available to conduct a valid weight of evidence evaluation of this substance.
- Grouping and read-across- There is no known grouping or other read-across information available that fully meets the developmental toxicity data requirements for this substance.
- Substance-tailored exposure driven testing [if applicable]- No information available
- 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 specific adaption possibilities of Annex VI to X (and column 2 thereof) are thought to be adequate to generate the necessary information.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]- Will follow standard OECD 414 protocol with rats
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Test material
- Reference substance name:
- Hydrocarbons, C18-C22, n-alkanes, n-alkenes
- EC Number:
- 953-917-1
- Molecular formula:
- not applicable, UVCB
- IUPAC Name:
- Hydrocarbons, C18-C22, n-alkanes, n-alkenes
- Test material form:
- solid: bulk
Constituent 1
Test animals
- Species:
- rat
Results and discussion
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.
