Registration Dossier

Administrative data

Description of key information

Oral (OECD TG 401), rat: LD50 > 2000 mg/kg bw (limit test)
Dermal: (OECD TG 402), rat: LD50 > 2000 mg/kg bw (limit test)
Inhalation: No measured data are available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

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
Quality of whole database:
The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Additional information

Studies were chosen as key when the available study was of relevance and of sufficient quality for classification, labelling and for risk assessment. 

A key acute oral limit test which was conducted in compliance with GLP and according to the now deleted OECD TG 401 is available on (3-chloropropyl)diethoxymethylsilane. Two out of five males died when dosed at 2000 mg/kg bw and the macroscopic examination of the two perished animals showed the most severe lesions in the stomach and the intestine. The mucosa of these tissues showed hyperaemia and haemorrhages. No macroscopic abnormalities were observed in animals killed on day 14. All animals showed severe clinical symptoms in the first six hours after treatment with the test substance. The symptoms seen were padding movements, gait abnormality; decreased activity and squatting position. 24 and 48 hours after treatment most of the animals showed still the described clinical signs. Only one male and one female showed these signs 72 hours after treatment with the test substance. Milder clinical signs like piloerection were observed until day 7. After 7 days until the end of the observation period there were no more signs of systemic reaction to treatment. The LD50to rats of (3-Chloropropyl)diethoxymethylsilane was found to be > 2000 mg/kg bw (Hüls AG, 1997a).

   

A key acute dermal toxicity study which was conducted in compliance with GLP and according to OECD TG 402 is available on (3-chloropropyl)diethoxymethylsilane, there was no mortality or any systemic effects seen at 2000 mg/kg bw (24 hour exposure). (LD0and LD50> 2000 mg/kg bw) (Hüls AG, 1997b). 

There are no inhalation data available.


Justification for selection of acute toxicity – oral endpoint
The key study was selected for assessment.

Justification for selection of acute toxicity – inhalation endpoint
In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5.2) does not need to be conducted as reliable data via the oral and dermal routes are available.

Justification for selection of acute toxicity – dermal endpoint
The key study was selected for assessment.

Justification for classification or non-classification

The available data on acute toxicity of the registered substance do not meet the criteria for classification according to Regulation 1272/2008 or EU Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.