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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Referenceopen allclose all

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:
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
Reference
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
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