Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

In key acute oral and dermal studies conducted according to appropriate guidelines and in compliance with GLP the LD50 was found to be > 2000 mg/kg bw.

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 a GLP study conducted in accordance with the now-deleted OECD TG 401, five male and five female rats were given a single limit dose of 2000 mg/kg bw tetrakis(2-butoxyethyl) orthosilicate by oral gavage. No deaths or clinical signs were observed in any of the animals. Reddening of the small bowel mucosa in one male rat was reported, but there were no macroscopic changes in the other nine animals. The LD50 was therefore >2000 mg/kg bw.

In an OECD 402 study, conducted to GLP, 2000 mg/kg bw tetrakis(2-butoxyethyl) orthosilicate was applied to the shaved, intact skin of five male and five female rats for 24 hours under a semi-occlusive dressing. No deaths or clinical signs were observed in any of the animals. Body weight gains were not affected by treatment and there were no changes to skin and subcutaneous tissues. Two males and one female had swollen and red stomach mucosa glands, and sometimes reddening of the small bowel mucosa. The dermal LD50 in rats is therefore >2000 mg/kg bw.

Justification for classification or non-classification

Based on the available data tetrakis(2-butoxyethyl) orthosilicate does not require classification for acute toxicity according to Regulation (EC) No 1272/2008.