Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

Toxicity to reproduction (fertility): no data available

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
Additional information

Toxicity to reproduction (fertility)

According to Regulation (EC) No 1907/2006, Annex VIII 8.7.1. Column 2, a screening study for reproductive/developmental toxicity for assessment of reproductive toxicity is not required if a pre-natal developmental toxicity study (Annex IX, 8.7.2) or an Extended One-Generation Reproductive Toxicity Study (Annex IX, Section 8.7.3) is available. A pre-natal developmental toxicity study (rat, oral route) with the source substance (structural analogue or surrogate) Ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters (CAS 116912-64-2) was proposed by the registrant and was accepted by ECHA (TPE-D-2114321095-60-01/F). Therefore, in order to assess the developmental toxicity of [3-(trimethoxysilyl)propyl]urea (CAS 23843-64-3), the ECHA approved GLP-compliant prenatal developmental toxicity study in the rat via the oral route following OECD 414 with the source substance Ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters (CAS 116912-64-2) will be read-across once available. The read-across will be conducted based on an analogue approach, in accordance with the Regulation (EC) 1907/2006 to avoid tests in terms of animal welfare. Details on read across justifications can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.

Effects on developmental toxicity

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
experimental study planned (based on read-across)
Study period:
The testing proposal on the read-across substance was accepted by ECHA (TPE-D-2114321095-60-01/F) on 03 Mar 2016 and the deadline to submit the required information is by 12 Mar 2018.
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters CAS 116912-64-2
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies: No adequate and reliable GLP studies addressing developmental toxicity or reproductive toxicity in general are available with the test substance itself or similar substances defined according to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No. 1907/2006.
- Available non-GLP studies: No adequate and reliable non-GLP studies addressing developmental toxicity or reproductive toxicity in general are available with the test substance or similar substances.
- Historical human data: not available
- (Q)SAR: Currently available Q(SAR) methods are not applicable to assess the full scope of developmental toxicity
- In vitro methods: No validated in vitro methods to assess developmental toxicity are available so far.
- Weight of evidence: So far there is no information (QSAR, in vitro data, repeated dose or fertility data) available which is suitable to assess developmental toxicity in a weight of evidence approach.
- Grouping and read-across: The proposed test is part of a sequential testing strategy program for alkoxysilanes which is developed in close collaboration with ECHA to minimise the need for additional animal testing.
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:
In order to fulfil the standard information requirements, a GLP-compliant pre-natal developmental toxicity study in rats via the oral route following OECD guideline 414 is proposed according to Annex IX, Column 1, Section 8.7.2.
Column 2 adaption possibilities at the Annex IX level where considered and do not apply: Based on the available data the test substance is not regarded as CMR substance. In particular it is not known to be a genotoxic carcinogen or germ cell mutagen. In addition it is not classified for reproductive toxicity Cat 1 or 2 in accordance with Regulation (EC) No. 1272/2008. In addition, there are no toxicokinetic studies available which could justify the absence of systemic absorption.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION: none
Qualifier:
according to
Guideline:
OECD Guideline 414 (Prenatal Developmental Toxicity Study)
Deviations:
no
Principles of method if other than guideline:
There are no data available to assess the developmental toxicity of [3-(triethoxysilyl)propyl]urea. However, a GLP-compliant prenatal developmental toxicity study (OECD 414) with the structural analogue substance ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters (CAS 116912-64-2) has been initiated at a contract research organisation.

The testing proposal for the OECD 414 study with the read-across substance ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters (CAS 116912-64-2) was accepted by ECHA (final decision communication number TPE-D-2114321095-60-01/F) on 03 Mar 2016 and the deadline to submit the required information is by 12 Mar 2018. Hence, the study has been initiated at BSL Bioservice, Planegg/Munich, Germany.

Within the analogue group of alkyl alkoxysilanes containing a urea group, in which [3-(triethoxysilyl)propyl]urea belongs, ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters (CAS 116912-64-2) has been selected as the most appropriate and representative member of the analogue group because of its structural features or chemical functional groups (alkoxysilane moiety and alkyl urea moiety), and therefore will be used to generate data on developmental toxicity (further information can be found in the read across justification document attached in section 7.8.2: Developmental toxicity / teratogenicity). Consequently, read-across of the developmental toxicity data from ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters (CAS 116912-64-2) to [3-(triethoxysilyl)propyl]urea ( CAS 23779-32-0) will be conducted based on an analogue approach, in accordance with the Regulation (EC) 1907/2006 to avoid tests in terms of animal welfare.
GLP compliance:
yes
Species:
rat
Route of administration:
oral: gavage
Abnormalities:
not specified
Developmental effects observed:
not specified
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