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Key value for chemical safety assessment

Effects on fertility

Description of key information
No other studies available.
Effect on fertility: via oral route
Dose descriptor:
NOAEL
750 mg/kg bw/day
Additional information

As a result of the reproduction / developmental screening study, the treatment-related effects were observed. However, due to the lack of evidence of adverse effects for these observations, it is reasonable to derive the NOAEL in reproductive and developmental toxicity for triisopropylsilyl acrylate is 750 mg/kg/day in the test condition. It is not possible to derive the separate NOAEL for fertility and developmental/teratogenicity due to the limitation of the study design.

The methodology of the test meets the requirements of OECD Test Guideline 421 and is assigned to be reliability 1 data according to the scoring system of Klimisch et al (Klimisch et al.,1997). This ranking was deemed appropriate because the study was conducted the GLP certified laboratory and was in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.


Short description of key information:
An screening test (OECD TG 421) was conducted to assess reproduction / developmental toxicity for the substance. The oral administration of triisopropylsilyl acrylate to rats by gavage, at dose levels of 750, 150 and 30 mg/kg/day, resulted in treatment-related effects in litters (reduced litter weights, reduced mean bodyweight gains and litter size of offspring) at 750 mg/kg/day, therefore, the ‘No Observed Effect Level’ (NOEL) was considered to be 150 mg/kg/day for reproductive toxicity. No other treatment-related effects were observed neither parental animals or offspring.

Effects on developmental toxicity

Description of key information
An screening test (OECD TG 421) was conducted to assess reproduction / developmental toxicity for the substance. The oral administration of triisopropylsilyl acrylate to rats by gavage, at dose levels of 750, 150 and 30 mg/kg/day, resulted in treatment-related effects in litters (reduced litter weights, reduced mean bodyweight gains and litter size of offspring) at 750 mg/kg/day, therefore, the ‘No Observed Effect Level’ (NOEL) was considered to be 150 mg/kg/day for reproductive toxicity. No other treatment-related effects were observed neither parental animals or offspring.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
750 mg/kg bw/day
Additional information

As a result of the reproduction / developmental screening study, the treatment-related effects were observed. However, due to the lack of evidence of adverse effects for these observations, it is reasonable to derive the NOAEL in reproductive and developmental toxicity for triisopropylsilyl acrylate is 750 mg/kg/day in the test condition. It is not possible to derive the separate NOAEL for fertility and developmental/teratogenicity due to the limitation of the study design.

The methodology of the test meets the requirements of OECD Test Guideline 421 and is assigned to be reliability 1 data according to the scoring system of Klimisch et al (Klimischet al.,1997). This ranking was deemed appropriate because the study was conducted the GLP certified laboratory and was in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Justification for classification or non-classification

The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).

Additional information