Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

According to Annex VIII, a fertility study is required for compounds with an average tonnage band > 10t/a. However, the study can be waived because a pre-natal developmental toxicity study is already proposed. When the OECD 414 study is completed, the information will be used to fill data requirements of this endpoint.

Up to now, no reprotoxic effects are known/seen for benzylated diethylenetriamine and triethylenetetramine.

Therefore, after receiving the results of the 90-day repeated dose toxicity study and the results of the OECD 414 study this toxicological endpoint will re-evaluate.

Link to relevant study records

Referenceopen allclose all

Endpoint:
extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the extended one-generation reproductive toxicity study does not need to be conducted because there are no results from available repeated dose toxicity studies that indicate adverse effects on reproductive organs or tissues, or reveal other concerns in relation with reproductive toxicity
other:
Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Effect on fertility: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

According to Annex IX a study for the endpoint developmental toxicity is required. An oral OECD 414 study with rats for the test material is proposed.

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
experimental study planned
Justification for type of information:
There are no GLP, non-GLP studies nor any historical human data for the registered substance available. Application of grouping, read-across and (Q)SAR is difficult due to the complex composition of the material (UVCB). Furthermore, the registrant is not aware of any In vitro method which can fulfil data requirements for this endpoint. There are no studies which can be used in combination to fullfil data requirements using weight of evidence approach. Substance-tailored exposure driven testing is not applicable for the registered substance and relevant uses.
According to Annex VIII, the OECD 414 prenatal toxicity study is required for compounds with an average tonnage band of >=100 t. Hence, we propose an oral OECD 414 study with rats.
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Species:
rat
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification