[3-(triethoxysilyl)propyl]urea

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Type of information:

other: read-across from ongoing study with structural analogue substance

Adequacy of study:

other information

Study period:

The testing proposal on the read-across substance was accepted by ECHA (TPE-D-2114321095-60-01/F) on 03.03.2016 and the deadline to submit the required information is by 12.03.2018.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Materials and methods

Test guideline

Qualifier:

according to guideline

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. Once the data is available it will be read-across to [3-(triethoxysilyl)propyl]urea (CAS 23779-32-0).

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 03.03.2016 and the deadline to submit the required information is by 12.03.2018. Hence, the study has been initiated at BSL Bioservice, Behringstr. 6/8, 82152 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

Test material information

Constituent 1

Reference substance name:

116912-64-2

Cas Number:

116912-64-2

IUPAC Name:

116912-64-2

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