Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

There are no oral, inhalation or dermal reproductive toxicity studies available for 3-[tris(acetoxy)silyl]propyl methacrylate. Information on the reproductive toxicity of acetic acid indicates that no effects on fertility would be expected from the production of acetic acid by the hydrolysis of 3-[tris(acetoxy)silyl]propyl methacrylate. Data waivers are in place for this endpoint.

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

In accordance with Section 2 of REACH Annex VIII a screening for reproductive toxicity (required in Section 8.6), using a validated test method and relevant guidelines, will be omitted because it is technically not feasible. This is due to the known corrosive effects of the hydrolysis product acetic acid, which were clearly evident in the range-finding study for the OECD 422 study for the read across substance triacetoxyethylsilane (CAS 17689-77-9). The corrosivity could affect the lining of the stomach, giving rise to hyperplasia and a subsequent reduced food intake. All of this would make the interpretation of any systemic findings difficult.

Acetic acid

Information on the reproductive toxicity of acetic acid is available (SIAR, 2005). No effects on fertility were observed following exposure of mice to 0.025% sodium acetate in drinking water for one week prior to breeding, during 9-day breeding period and during pregnancy, lactation and until the offspring were weaned at 3 weeks of age. Acetic acid had no effects on implantation or on maternal survival in rats, mice or rabbits dosed via gavage during gestation days 6-19 at doses up to 1600 mg/kg bw/day. Sodium acetate had no effect on pregnant mice when mice were administered 1000 mg/kg bw/day, by gavage on days 8-12 of gestation.

Effects on developmental toxicity

Description of key information

There are no oral, inhalation or dermal developmental toxicity studies available for 3-[tris(acetoxy)silyl]propyl methacrylate. Information on the developmental toxicity of acetic acid indicates that no effects on development would be expected from the production of acetic acid by the hydrolysis of 3-[tris(acetoxy)silyl]propyl methacrylate. Data waivers are in place for this endpoint.

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

In accordance with Section 2 of REACH Annex VIII a screening for developmental toxicity (required in Section 8.6), using a validated test method and relevant guidelines, will be omitted because it is technically not feasible. This is due to the known corrosive effects of the hydrolysis product acetic acid, which were clearly evident in the range-finding study for the OECD 422 study for the read across substance triacetoxyethylsilane (CAS 17689-77-9). The corrosivity could affect the lining of the stomach, giving rise to hyperplasia and a subsequent reduced food intake. All of this would make the interpretation of any systemic findings difficult.

Acetic acid

Information on the reproductive toxicity of acetic acid is available (SIAR, 2005). Following exposure of mice to 0.025% sodium acetate in drinking water for one week prior to breeding, during 9-day breeding period and during pregnancy, lactation and until the offspring were weaned at 3 weeks of age, the male offspring were given the same solution until they were 5-7 weeks old and were then examined in a 24-hour activity test. No overt deformities were observed and pup weights were normal at day 1 and day 21. The activity of offspring of the treated group was lower than that of controls during the first 12 hours but was similar during the second 12 hours. It is unknown if the decreased activity observed in the sodium acetate treated group to was a result of exposure in utero and/or post-weaning, since the pups were exposed during both time periods.

Acetic acid had no effects on fetal survival in rats, mice or rabbits dosed via gavage during gestation days 6-19 at doses up to 1600 mg/kg/day. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring in the controls.

Sodium acetate had no effect on pregnant mice or offspring when mice were administered 1000 mg/kg bw, by gavage on days 8-12 of gestation.



Justification for classification or non-classification

Based on the available information, the registered substance does not require classification for reproductive or developmental toxicity according to Regulation (EC) No 1272/2008.