N,N-bis(trimethylsilyl)aminopropylmethyldiethoxysilane

Endpoint summary

Description of key information

In the key acute oral toxicity study, conducted according to OECD TG 423 and in compliance with GLP, the estimated LD₅₀ value was in the range of 500 - 1000 mg/kg bw (Safepharm, 2002).

In the key acute dermal toxicity study, conducted according to OECD TG 402 and in compliance with GLP, the reported LD₅₀ value was greater than 2000 mg/kg bw (Safepharm, 2003).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

In the key acute oral toxicity study, conducted according to OECD TG 423 and in compliance with GLP, the estimated LD₅₀ value was in the range of 500 - 1000 mg/kg bw (Safepharm, 2002).

Following oral gavage exposure of 3 female rats to 2000 mg/kg bw test material in arachis oil BP, two animals were found dead one day after dosing. The observed signs of toxicity included hunched posture, lethargy, ataxia, decreased respiratory rate and laboured respiration. Based on the results from this dose level another 2 groups of 3 females were administered 300 mg/kg bw of test material in arachis oil BP. No deaths occurred after exposure to 300 mg/kg bw test material. No signs of systemic toxicity were noted in any of the animals from these groups.

All the surviving animals showed expected body weight gain except for one animal treated at dose level of 300 mg/kg bw, which showed a body weight loss during the second week of the study. Abnormally red lungs, dark liver and dark kidneys were noted at necropsy in animals that died during the study period. No abnormalities were noted in animals that were killed at the end of the study period.

In the key acute dermal toxicity study, conducted according to OECD TG 402 and in compliance with GLP, the reported LD50 value was greater than 2000 mg/kg bw (Safepharm, 2003).

Following a 24 -hour dermal application of 2000 mg/kg bw of undiluted test material to intact skin of 5 male and 5 female rats, no deaths occurred or signs of systemic toxicity. Well-defined erythema and very slight oedema were noted at the treatment sites of all the animals. Treatment sites appeared normal five to six days after dosing. All animals showed the expected body weight gain. No macroscopic abnormalities were noted at necropsy.

Justification for classification or non-classification

Based on the available data for N,N-bis(trimethylsilyl)aminopropylmethyldiethoxysilane, the test material is classified as Category 4, H302: "Harmful if swallowed" for acute oral toxicity and no classification is required for acute dermal toxicity according to Regulation (EC) No. 1272/2008.