Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study planned
Study period:
Awaiting for ECHA approval
Justification for type of information:
CONSIDERATIONS OF ALTERNATIVE METHODS ON TESTING PROPOSALS IN YOUR REGISTRATION


Public substance name: 5,5'-dithiobis-1,3,4-thiadiazole-2(3H)-thione
EC Number: 276-763-0
CAS Number: 72676-55-2

Date of considerations: 3 April 2020


Hazard endpoint for which vertebrate testing was proposed:

Reproductive toxicity (oral pre-natal developmental toxicity in rats, OECD TG no. 414) with the registered substance;

Considerations that the general adaptation possibilities of Annex XI of the REACH Regulation were not adequate to generate the necessary information

• available GLP studies: None.

• available non-GLP studies: None.

• historical human data: None.

• (Q)SAR
According to ECHA guidance R.7a (October 2015, page 382), QSAR approaches are currently not well fitted-for-purpose for reproductive toxicity and not all necessary aspects can be covered by a QSAR prediction.

• in vitro methods
In vitro reproduction studies are not available on the test substance.
Some in vitro test methods have been developped, however, according to Chapter R 7a (October 2015, page 381), the regulatory acceptance of these in vitro methods has not been achieved as they do not provide equivalent information.

• weight of evidence: No data is available which allow a weight of evidence approach.

• grouping and read-across: No data is available which allow a read across approach.

• 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) were not applicable:

Test proposal is fully compliant with ECHA guidance R 7.a (Oct 2015, page 373). No specific adaptation possibilities of Annexes VI to X (and column 2 thereof) are applicable.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
GLP compliance:
yes (incl. QA statement)
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
5,5'-dithiodi-1,3,4-thiadiazole-2(3H)-thione
EC Number:
276-763-0
EC Name:
5,5'-dithiodi-1,3,4-thiadiazole-2(3H)-thione
Cas Number:
72676-55-2
Molecular formula:
C4-H2-N4-S6
IUPAC Name:
5-[(5-sulfanylidene-4,5-dihydro-1,3,4-thiadiazol-2-yl)disulfanyl]-2,3-dihydro-1,3,4-thiadiazole-2-thione

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Applicant's summary and conclusion