Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: gavage

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion