Registration Dossier

Administrative data

Description of key information

In the key acute oral toxicity study, conducted to the now-deleted OECD 401 Test Guideline and in compliance with GLP, an LD50 value of greater than 2000 mg/kg bw was reported (Dow Corning Corporation 1990a).

In the key acute dermal toxicity study, conducted according to an appropriate OECD 402 Test Guideline and in compliance with GLP, an LD50 value of greater than 2000 mg/kg bw was reported (Dow Corning Corporation, 1990b).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 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 to the now-deleted OECD 401 Test Guideline and in compliance with GLP, an LD50 value of > 2000 mg/kg bw was reported (Dow Corning Corporation, 1990a).

Following a single oral gavage administration of 2000 mg/kg bw to 5 male and 5 female rats of undiluted test material, no test substance-related mortality, clinical signs of toxicity or body weight changes occurred. Nor were any gross macroscopic abnormalities noted. One female died prior to end of the observation period and its death was considered to be related to gavage treatment.

In the key acute dermal toxicity study, conducted according to an appropriate OECD 402 Test Guideline and in compliance with GLP, an LD50 value of greater than 2000 mg/kg bw was reported (Dow Corning Corporation, 1990b).

Following a 24-hour dermal application of 2000 mg/kg bw undiluted test material to the dorsal area of 5 male and 5 female rabbits,

no test substance-related mortality, clinical signs of toxicity or body weight changes occurred. No gross macroscopic abnormalities were noted.

Justification for classification or non-classification

Based on the available data, no classification is required for Reaction Mass of trimethoxy(aminoalkyl)silanes and modified alkylether oligomers for acute toxicity according to Regulation (EC) No. 1272/2008.