Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

There are no oral, inhalation or dermal reproductive toxicity studies available for trichloro(propyl)silane. Data waivers are in place for this endpoint.

Limited data are available regarding the reproduction and development of animals following oral, dermal or inhalation exposure to hydrogen chloride or hydrochloric acid, however, protons and chloride ions both exist as normal constituents of body fluid in animals, hence low concentrations of hydrogen chloride appear not to cause adverse effects in animals. Therefore hydrochloric acid would not contribute to any reproductive toxicity (fertility or developmental) effects at the dose levels tested.

Link to relevant study records
Reference
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:
other:
Effect on fertility: via oral route
Endpoint conclusion:
no study available
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

There is an ongoing pre-natal developmental toxicity study, according to OECD TG 414 and in compliance with GLP, with the registered substance CAS 141-57-1. The study is expected to be finalised by January 2020, when the substance will be updated with the study results.

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Study period:
The test is ongoing. The report is expected in March 2020 and a dossier update will be submitted by the end of May 2020.
Data waiving:
other justification
Justification for data waiving:
other:
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
Additional information

Dose range-finding studies for prenatal developmental toxicity studies (OECD 414) have also been conducted for another two chlorosilanes: dichloro(methyl)phenylsilane (CAS 149-74-6) and dichlorocyclohexylmethylsilane (CAS 5578-42-7). These dose range-finding studies have been added to this dataset to demonstrate consistency of effects among chlorosilane substances. For additional details please see the expert report attached to Section 13 of IUCLID (Weber, 2019). The summary also includes findings from a dose range-finding study for a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422) with tert-butylchlorodimethylsilane (CAS 18162-48-6), which has not been added to the dataset

Justification for classification or non-classification

The available data indicate that trichloro(propyl)silane does not need to be classified for toxicity to reproduction (fertility or developmental toxicity) according to Regulation (EC) No 1272/2008.

Additional information