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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
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 Sub-chronic toxicity study (90-day) (OECD 408), is ongoing and the audited draft report is not available yet.
The draft report for OECD 408 is estimated for April 2022. See attached justification in this study record.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2022

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
GLP compliance:
yes (incl. QA statement)
Limit test:
no

Test material

Constituent 1
Chemical structure
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

Test animals

Species:
rat
Strain:
Wistar
Details on species / strain selection:
Han Wistar (RccHan: WIST) rat
Sex:
male/female
Details on test animals or test system and environmental conditions:
A study for this endpoint is in progress based on ECHA decision number TPE-D-2114510115-67-01/F. A Sub-chronic toxicity study (90-day) (OECD 408), is ongoing and the audited draft report is not available yet.
The draft report for OECD 408 is estimated for April 2022. See attached justification in this study record.

Administration / exposure

Route of administration:
oral: gavage
Details on route of administration:
A study for this endpoint is in progress based on ECHA decision number TPE-D-2114510115-67-01/F. A Sub-chronic toxicity study (90-day) (OECD 408), is ongoing and the audited draft report is not available yet.
The draft report for OECD 408 is estimated for April 2022. See attached justification in this study record.
Vehicle:
other: Solutol HS 15 / Ethanol / Water = 4:1:5
Analytical verification of doses or concentrations:
yes
Details on analytical verification of doses or concentrations:
A study for this endpoint is in progress based on ECHA decision number TPE-D-2114510115-67-01/F. A Sub-chronic toxicity study (90-day) (OECD 408), is ongoing and the audited draft report is not available yet.
The draft report for OECD 408 is estimated for April 2022. See attached justification in this study record.
Frequency of treatment:
According to study plan: once daily at approx. the same time each day
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
7 mg/kg bw/day (nominal)
Dose / conc.:
20 mg/kg bw/day (nominal)
Dose / conc.:
60 mg/kg bw/day (nominal)
No. of animals per sex per dose:
According to study plan 10 females and 10 males
Control animals:
yes, concurrent vehicle

Examinations

Observations and examinations performed and frequency:
A study for this endpoint is in progress based on ECHA decision number TPE-D-2114510115-67-01/F. A Sub-chronic toxicity study (90-day) (OECD 408), is ongoing and the audited draft report is not available yet.
The draft report for OECD 408 is estimated for April 2022. See attached justification in this study record.

Results and discussion

Results of examinations

Details on results:
A study for this endpoint is in progress based on ECHA decision number TPE-D-2114510115-67-01/F. A Sub-chronic toxicity study (90-day) (OECD 408), is ongoing and the audited draft report is not available yet.
The draft report for OECD 408 is estimated for April 2022. See attached justification in this study record.

Effect levels

Remarks on result:
other: A study for this endpoint is in progress based on ECHA decision number TPE-D-2114510115-67-01/F. A Sub-chronic toxicity study (90-day), is ongoing and the audited draft report is not available yet. The draft report for OECD 408 is estimated for April 2022

Target system / organ toxicity

Critical 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 Sub-chronic toxicity study (90-day) (OECD 408), is ongoing and the audited draft report is not available yet.
The draft report for OECD 408 is estimated for April 2022. 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 Sub-chronic toxicity study (90-day) (OECD 408), is ongoing and the audited draft report is not available yet.
The draft report for OECD 408 is estimated for April 2022. See attached justification in this study record.