Registration Dossier

Administrative data

Description of key information

The key study for acute oral toxicity, conducted accoding to the appropriate OECD guideline and in compliance with GLP, reports an LD50 value of >5000 mg/kg in female rats (NOTOX 2011).  The key study for acute dermal toxicity, conducted according to the appropriate OECD guideline and in compliance with GLP, reports an LD50 value of >2000 mg/kg in rats (Harlan 2012).  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.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 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
2 000 mg/kg bw

Additional information

An LD50 value of >5000 mg/kg is reported in female rats, in a reliable study conducted accoding to the appropriate OECD guideline and in compliance with GLP (NOTOX 2011). There were no mortalities. All animals showed hunched posture on day 1. Three animals also showed piloerection on day 1. The body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals.

An LD50 value of >2000 mg/kg is reported in a reliable study conducted accoding to the appropriate OECD guideline and in compliance with GLP (Harlan 2012). There were no mortalities. No clinical signs were observed throughout the entire observation period. Slight erythema was observed in one of five males and in one of five females after test item application on test day 2. This sign of skin irritation was reversible in both animals. No local dermal signs were observed in any animal from test day 3 until the end of the observation period. Two females slightly lost body weight after treatment, one of them in the first week after treatment , the second in both weeks after treatment. Otherwise the body wight of the animals was within the range commonly recorded for this strain and age. No abnormalities were found at macroscopic post mortem examination of the animals.


Justification for classification or non-classification

Based on the available information, no classification is required for acute toxicity of 3,3-bis[(dimethyvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane in accordance with Regulation (EC) No 1272/2008.