Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Acute oral toxicity: LD50 890 mg/kg bw, OECD Guideline 401, GLP compliant (Dow Corning Corporation, 1985).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
890 mg/kg bw
Quality of whole database:
The study was conducted according to an 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 study available

Additional information

According to the integrated testing strategy, no data are required for acute toxicity due to the corrosive nature of [2-(perfluorobutyl)ethyl]dichloro(methyl)silane. Acute toxicity studies were already available for the substance and these are included in the dossier for completeness.

[2-(Perfluorobutyl)ethyl]dichloro(methyl)silane has been tested for acute oral toxicity according to OECD 401 and in compliance with GLP (Dow Corning Corporation, 1985). The study is considered to be reliability 2 because only two rats were treated per dose level, and the reporting is limited. Undiluted test material was administered by gavage to one male and one female rat per dose at 316, 630, 1260 and 2520 mg/kg bw. All animals administered 1260 and 2520 mg/kg bw died, the females on day 0 and the males on day 2. It is concluded that the LD50 is 890 mg/kg bw under the conditions of the test. This study was selected as key because, although it is of lower reliability and older than the other available study, it gives a more conservative estimate of the LD50.

A second acute oral toxicity study is available in which [2-(perfluorobutyl)ethyl]dichloro(methyl)silane was tested according to OECD 401 and in compliance with GLP (TNO, 1986). The test substance was diluted with maize oil prior to administration by gavage to six groups of 5 male and 5 female rats. Doses ranged from 2500 to 5190 mg/kg bw. Some rats at the lowest doses and all rats dosed with 3600 mg/kg bw lost consciousness within an hour of dosing. Later, clinical signs including coma were observed. No gross abnormalities were observed on autopsy of rats that died and of survivors. Animals that survived recovered gradually. Deaths occurred in all dose groups, and weight loss or growth retardation were observed in some rats. The LD50 was determined to be 2593 mg/kg bw.


Justification for classification or non-classification

[2-(Perfluorobutyl)ethyl]dichloro(methyl)silane is classified Acute Toxicity Category 4 - oral, with hazard statement H302: 'Harmful if swallowed' according to Regulation (EC) No 1272/2008.