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]

Endpoint summary

Description of key information

Repeated dose toxicity:oral

A sub-acute 28-day repeated dose toxicity study is not necessary because a sub-chronic (90 days) study is proposed to be conducted with an appropriate species, dosage, solvent and route of administration.

Repeated dose toxicity:oral (90 day)

A testing proposal for an OECD 408/GLP study in rats has been submitted in the dossier.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records

Reference

Reference 1

Endpoint:

sub-chronic toxicity: oral

Type of information:

experimental study planned

Study period:

After final decision is issued.

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 sub-chronic toxicity oral endpoint.
- Available non-GLP studies: A literature search was conducted and no non-GLP studies were found for the sub-chronic toxicity oral endpoint.
- Historical human/control data: A literature search was conducted and no historical human data was found for the sub-chronic toxicity oral endpoint.
- (Q)SAR: QSAR could not be applied for the sub-chronic toxicity oral 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 sub-chronic toxicity oral 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 sub-chronic toxicity oral 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 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)

GLP compliance:

yes (incl. QA statement)

Species:

rat

Route of administration:

oral: gavage

Reference 2

Endpoint:

short-term repeated dose toxicity: oral

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study does not need to be conducted because a sub-chronic (90 days) or chronic toxicity study is proposed to be conducted with an appropriate species, dosage, solvent and route of administration

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no study available