Registration Dossier

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
[Please provide information for all of the points below. The information should be specific to the endpoint for which testing is proposed. Note that for testing proposals addressing testing on vertebrate animals under the REACH Regulation this document will be published on the ECHA website along with the third party consultation on the testing proposal(s).]

NON-CONFIDENTIAL NAME OF SUBSTANCE:
Tetra(isobutyl)thioperoxydicarbamic acid
EC Number: 221-312-5
CAS Number: 3064-73-1

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
Literature search was conducted and no GLP studies were found for Repeated dose toxicity (90 days) endpoint.

- Available non-GLP studies
Literature search was conducted and no non-GLP studies were found for Repeated dose toxicity (90 days) endpoint.

- Historical human data
Literature search was conducted and no historical human data was found for Repeated dose toxicity (90 days) endpoint.

- (Q)SAR
According to ECHA’s guidance on the information requirements and chemical safety assessment, chapter R7a, compared with some other endpoints, the possibility to use (Q)SAR models for the prediction of repeated dose toxicity in a regulatory context is limited. This limitation is due to the complexity of the systemic interactions and effects involved in repeated dose toxicity studies. This complexity is difficult to predict with computational tools.
We tried QSAR Toolbox V4.1, the result from Repeated dose HESS is ‘Thiocarbamates/Sulfides (Hepatotoxicity) No rank’.
In summary, (Q)SAR could not be applied for Repeated dose toxicity (90 days) endpoint for this substance.

- In vitro methods
There are no available in vitro data for Repeated dose toxicity (90 days) endpoint of this substance.
According to ECHA’s guidance on the information requirements and chemical safety assessment, chapter R7a, data from currently available in vitro tools are not considered adequate to be used on their own for regulatory decision making with respect to risk assessment and C&L for repeated dose toxicity. In vitro methods could not be applied for Repeated dose toxicity (90 days) endpoint for this substance.

- Weight of evidence
Literature search was conducted and no insufficient data was found to be used as Weight of evidence for Repeated dose toxicity (90 days) endpoint.

- Grouping and read-across
Potential candidates for read-across are structurally similar compounds such as 4,4'-methylene bis(dibutyldithiocarbamate)(EC number: 233-593-1 | CAS number: 10254-57-6)and Tetrabutylthioperoxydicarbamic acid (EC number: 216-652-6 | CAS number: 1634-02-2). Only OECD422 test data of 4,4'-methylene bis(dibutyldithiocarbamate) is available. The available OECD422 test data on this substance is not sufficient to cover data requirement on Repeated dose toxicity (90 days) endpoint. Grouping and read-across could not be applied for Repeated dose toxicity (90 days) endpoint for this substance.

- Substance-tailored exposure driven testing [if applicable]
Not applicable

- Approaches in addition to above [if applicable]
Not applicable

- Other reasons [if applicable]
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:
- [free text]
Adaptation options as defined in Annexes VI to X were not applicable for Repeated dose toxicity (90 days) endpoint of this substance.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed [if relevant]
Not relevant.

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion