Registration Dossier

Administrative data

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 : Reaction mass of Di-μ-thio-[{bis(2-ethylhexyl)carbamato-S,S’}oxo molybdenum(V)], Di-μ-thio-[{(2-ethylhexyl)carbamato-S,S’}{(branched ditridecyl)carbamato-S,S’}oxo molybdenum(V)] and Di-μ-thio-[{bis(branched ditridecyl)carbamato-S,S’}oxo molybdenum(V)]


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 : OECD 421, OECD 407
- Available non-GLP studies : none
- Historical human data : none
- (Q)SAR : none
- In vitro methods : no method available
- Weight of evidence : not sufficient data
- Grouping and read-across : not sufficient data
- Substance-tailored exposure driven testing [if applicable] : not applicable
- Approaches in addition to above [if applicable] : not applicable
- Other reasons [if applicable] : none

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:
The substance did not exhibit significant toxicity in the available mammalian studies. However, the effect on body weight development in the OECD 421 study indicates that the substance could be systemically available after oral dosing. Therefore, performance of the OECD 414 study is proposed according to the REACH Regulation Annex IX.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Version / remarks:
2018
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion