Registration Dossier
Registration Dossier
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EC number: 234-196-6 | CAS number: 10591-84-1
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2021-2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- A study for this endpoint is in progress based on ECHA decision number TPE-D-2114510115-67-01/F. A pre-natal developmental toxicity study in a first species (OECD 414) is ongoing and the audited draft report is not available yet.
The draft report for OECD 414 is estimated for July 2022 at the moment. See attached justification in this study record.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- N,N'-dimethyldiphenylthiuram disulphide
- EC Number:
- 234-196-6
- EC Name:
- N,N'-dimethyldiphenylthiuram disulphide
- Cas Number:
- 10591-84-1
- Molecular formula:
- C16H16N2S4
- IUPAC Name:
- N-methyl-N-phenyl{[methyl(phenyl)carbamothioyl]disulfanyl}carbothioamide
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- RccHan:WIST
Administration / exposure
- Route of administration:
- oral: gavage
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 10 mg/kg bw/day (nominal)
- Dose / conc.:
- 30 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- According to study plan 22 females in main study and 5 in satellite phase
- Control animals:
- yes, concurrent vehicle
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Remarks on result:
- other: A study for this endpoint is in progress based on ECHA decision number TPE-D-2114510115-67-01/F. A pre-natal developmental toxicity study in a first species (OECD 414) is ongoing and the audited draft report is not available yet.
Results (fetuses)
Effect levels (fetuses)
- Remarks on result:
- other: A study for this endpoint is in progress based on ECHA decision number TPE-D-2114510115-67-01/F. A pre-natal developmental toxicity study in a first species (OECD 414) is ongoing and the audited draft report is not available yet.
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- A study for this endpoint is in progress based on ECHA decision number TPE-D-2114510115-67-01/F. A pre-natal developmental toxicity study in a first species (OECD 414) is ongoing and the audited draft report is not available yet.
The draft report for OECD 414 is estimated for July 2022 at the moment. See attached justification in this study record. - Executive summary:
A study for this endpoint is in progress based on ECHA decision number TPE-D-2114510115-67-01/F. A pre-natal developmental toxicity study in a first species (OECD 414) is ongoing and the audited draft report is not available yet.
The draft report for OECD 414 is estimated for July 2022 at the moment. See attached justification in this study record.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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