Registration Dossier

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 : 1,1'-[[3-(dimethylamino)propyl]imino]bispropan-2-ol

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies :
A combined repeated dose toxicity study with reproduction/developmental toxicity screening test was performed with the test substance (according to OECD guideline 422; Betancourt Martell A, 2013)

- Available non-GLP studies :
Acute toxicity (oral): Acute oral toxicity study in rats, Auletta CS, 1979, K2
Acute toxicity (dermal): Acute dermal toxicity study in rabbits, Auletta CS, 1979, K2
Skin irritation (in vivo): Primary Dermal Irritation in Rabbits, Moreno OM, 1979, K2
Skin irritation (in vivo): Report on DOT test for material corrosivity in albino rabbits, Moreno OM, 1979, K2
Eye irritation (in vivo): Report on Rabbit Eye Irritation, Moreno OM, 1979, K2

- 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 : Some in vitro methods have been developed; however, according to ECHA Guidance document R.7a (Dec 2016) these in vitro methods have not reached regulatory acceptance and do not provide equivalent information.
- Weight of evidence: No data is available which would allow a weight of evidence approach
- Grouping and read-across: There is an unacceptable level of uncertainty regarding identification and selection of structurally and/or mechanistically related source substances.
- Substance-tailored exposure driven testing: The registered substance is only handled in industrial or commercial installations using closed systems and/or handled only as preparations at low concentrations, a sub-chronic study should be considered.
- Approaches in addition to above: not applicable
- Other reasons: 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:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Details described in study specific records

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Applicant's summary and conclusion