Registration Dossier
Registration Dossier
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EC number: 835-183-3 | CAS number: 83420-16-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Toxicity to Reproduction (Screening): The study is waived because a testing proposal for an OECD 414/GLP study in rats has been submitted in the dossier.
Extended one-generation reproductive toxicity: The study does not need to be conducted because a 90-day repeated dose toxicity study (OECD 408) in the rat is proposed. When the results are available, this data requirement will be re-considered.
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:
- Endpoint:
- extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
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
Additional information
Toxicity to Reproduction (Screening):
The study is waived because a testing proposal for an OECD 414/GLP study in rats has been submitted in the dossier.
Extended one-generation reproductive toxicity:
The study does not need to be conducted because a 90-day repeated dose toxicity study (OECD 408) in the rat is proposed. When the results are available, this data requirement will be re-considered.
Effects on developmental toxicity
Description of key information
Prenatal developmental toxicity
A testing proposal for an OECD 414/GLP study in rats has been submitted in the dossier.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study planned
- 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: N4,N4'-hexane-1,6-diylbis[N-butyl-6-chloro-N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine]
CAS Number: 83420-16-0
EC Number: 835-183-3
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: A literature search was conducted and no GLP studies were found for the prenatal developmental toxicity study endpoint.
- Available non-GLP studies: A literature search was conducted and no non-GLP studies were found for the prenatal developmental toxicity study endpoint.
- Historical human/control data: A literature search was conducted and no historical human data was found for the prenatal developmental toxicity study endpoint.
- (Q)SAR: QSAR could not be applied for the prenatal developmental toxicity study) endpoint for this substance.
- In vitro methods: Not applicable
- Weight of evidence: A literature search was conducted and no data was found that could be used in a Weight of evidence approach for the prenatal developmental toxicity study endpoint.
- Grouping and read-across: No substances with relevant available studies were found.
- 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:
Adaptation options as defined in Annexes VI to X were not applicable for the prenatal developmental toxicity study endpoint of this substance.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]: Not relevant. - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rat
- Route of administration:
- oral: gavage
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Prenatal developmental toxicity
A testing proposal for an OECD 414/GLP study in rats has been submitted in the dossier.
Justification for classification or non-classification
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.
