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Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

There are no key reproductive toxicity data available for trimethoxy(octyl)silane (CAS 3069-40-7). In the available 90-day oral repeated dose toxicity study with trimethoxy(octyl)silane, conducted according to OECD Test Guideline 408 and in compliance with GLP (BSL Bioservice, 2020), no treatment-related effects were observed in the examined reproductive organs and tissues during macroscopic and histopathology examinations. In addition, no effects were noted on the thyroid hormone levels. There is an ongoing prenatal developmental toxicity study with the registered substance in line with ECHA final decision No TPE-D-2114455992-37-01/F. Further testing for reproductive toxicity will be considered when the results from the ongoing study are 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

There are no key reproductive toxicity data available for trimethoxy(octyl)silane (CAS 3069-40-7). In the available 90-day oral repeated dose toxicity study with trimethoxy(octyl)silane, conducted according to OECD Test Guideline 408 and in compliance with GLP (BSL Bioservice, 2020), no treatment-related effects were observed in the examined reproductive organs and tissues during macroscopic and histopathology examinations. In addition, no effects were noted on the thyroid hormone levels. There is an ongoing prenatal developmental toxicity study with the registered substance in line with ECHA final decision No TPE-D-2114455992-37-01/F. Further testing for reproductive toxicity will be considered when the results from the ongoing study are available.

In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with trimethoxy(octyl)silane, conducted according to OECD Test Guideline 422 and in compliance with GLP, a NOAEL of 300 mg/kg bw/day was concluded for reproduction toxicity based on no effects on estrous cyclicity, litter data, litter weight data, precoital interval and duration of gestation, pre- and post-natal data, reproductive indices, pup survival data, anogenital distance and nipple retention, pup thyroid weight and thyroid hormone analysis in parental males and pups sacrificed on PND 13 and male sacrificed at the end of recovery period and pup external findings in all dose groups for which data could be obtained (Eurofins Munich / BSL Munich 2018). This study is included as supporting information but is not considered to be key due to certain methodological deficiencies, which are described in more detail in the IUCLID dataset.

Effects on developmental toxicity

Description of key information

There are no key developmental toxicity data available for trimethoxy(octyl)silane (CAS 3069-40-7). Therefore, there is an ongoing prenatal developmental toxicity study with the registered substance in line with ECHA final decision No TPE-D-2114455992-37-01/F. The study results will be submitted at a later date.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
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

There are no key developmental toxicity data available for trimethoxy(octyl)silane (CAS 3069-40-7). Therefore, there is an ongoing prenatal developmental toxicity study with the registered substance in line with ECHA final decision No TPE-D-2114455992-37-01/F. The study results will be submitted at a later date.

In the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with trimethoxy(octyl)silane, conducted according to OECD Test Guideline 422 and in compliance with GLP, a NOAEL of 300 mg/kg bw/day was concluded for developmental toxicity based on no effects on litter data, litter weight data, pup survival data, anogenital distance and nipple retention, pup thyroid weight and thyroid hormone analysis and pup external findings in all dose groups for which data could be obtained (Eurofins Munich / BSL Munich 2018). This study is included as supporting information but is not considered to be key due to certain methodological deficiencies, which are described in more detail in the IUCLID dataset.

Justification for classification or non-classification

Based on the lack of data, trimethoxy(octyl)silane is not classified for adverse effects to reproduction or development according to Regulation (EC) No 1272/2008.

Additional information