Registration Dossier

Administrative data

Endpoint:
developmental toxicity
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 Developmental toxicity / teratogenicity endpoint.

- Available non-GLP studies
Literature search was conducted and no non-GLP studies were found for Developmental toxicity / teratogenicity endpoint.

- Historical human data
Literature search was conducted and no historical human data was found for Developmental toxicity / teratogenicity endpoint.

- (Q)SAR
According to ECHA’s guidance on the information requirements and chemical safety assessment, chapter R7a, a negative result from current QSAR models predicting that the substance has not a particular property, cannot be interpreted as demonstrating the absence of a reproductive hazard unless there is other supporting evidence. Another limitation of QSAR modelling is that dose response information, for example the N(L)OAEL, required for risk assessment is not provided.
We have tried VEGA (Q)SAR platform and the Danish QSAR database. All the results are negative or inconclusive and the predicted compound is outside the Applicability Domain of the model. We have tried also OECD QSAR toolboxv4.1, the result from DART scheme v1.0 is ‘ Not known precedent reproductive and developmental toxic potential’.
In summary, QSAR could not be applied for Developmental toxicity / teratogenicity endpoint for this substance.

- In vitro methods
There are no available in vitro data of Developmental toxicity / teratogenicity endpoint.
In accordance with ECHA’s guidance on the information requirements and chemical safety assessment, chapter R7a, there are no validated alternative in vitro test methods and accepted for regulatory for Developmental toxicity / teratogenicity endpoint.
In vitro methods could not be applied for Developmental toxicity / teratogenicity 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 Developmental toxicity / teratogenicity 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).There were no available Developmental toxicity / teratogenicity for the two similar compounds. Grouping and read-across could not be applied for Developmental toxicity / teratogenicity 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 Developmental toxicity / teratogenicity 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 414 (Prenatal Developmental Toxicity Study)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion