Registration Dossier

Diss Factsheets

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

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Constituent 1
Chemical structure
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

Results and discussion

Applicant's summary and conclusion

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