1,4-dimethylpiperazine

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

experimental study planned

Study period:

to be determined by ECHA

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 : 1, 4-dimethylpiperazine

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies : there are no GLP studies available with the test substance
- Available non-GLP studies : there are no non-GLP studies available with the test substance
- Historical human data: no data available
- (Q)SAR : No (Q)SAR data can be used in a stand alone approach to assess the developmental toxicity potential. According to ECHA guidance document R.7a (Dec 2016), QSAR approaches are currently not fitted-for-purpose for reproductive toxicity and not all necessary aspects can be covered by a QSAR prediction
- In vitro methods : No in vitro method is available. Some in vitro test methods have been developed; however, according to ECHA guidance document R.7a (Dec 2016) these in vitro methods have not yet reach regulatory acceptance and do not provide stand alone, equivalent information.
- Weight of evidence: No data is available which would allow a weight of evidence approach
- Grouping and read-across : No chemical grouping or read-across approach was identified
- 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:
- This test proposal is fully compliant with the ECHA guidance document R.7a (Dec 2016). It is not possible to waive the study based on column 2 adaptations of the REACH regulation.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- No additional information

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Test material information

Constituent 1

Reference substance name:

1,4-dimethylpiperazine

EC Number:

203-412-0

EC Name:

1,4-dimethylpiperazine

Cas Number:

106-58-1

Molecular formula:

C6H14N2

IUPAC Name:

1,4-dimethylpiperazine

Details on test material:

- Name of test material (as cited in study report): Jeffcat DMP

Test animals

Species:

rat

Administration / exposure

Route of administration:

oral: gavage