Registration Dossier

Administrative data

Description of key information

A reliable key study for acute oral toxicity reports an LD50 value of 6.17 ml/kg (estimated to be equivalent to 6108 mg/kg bw) in rat conducted according to a protocol equivalent to current guideline but not compliant with GLP (Carnegie-Mellon 1976).  A reliable key study for acute dermal toxicity reports and LD50 value of 2.52 ml/kg (estimated to be equivalent to 2494 mg/kg bw) in rat, conducted according to a protocol equivalent to guideline but not compliant with GLP (Carnegie-Mellon 1976). The acute inhalation toxicity endpoint is waived, since reliable data for the acute oral and dermal endpoints are in place.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
6 108 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:
2 494 mg/kg bw

Additional information

The key study for acute oral toxicity reports an LD50 value of 6.17 ml/kg (estimated to be equivalent to 6108 mg/kg bw) in rat in a reliable study conducted according to a protocol equivalent to guideline (Carnegie-Mellon 1976). In the highest dose group (16 ml/kg) the animals were seen to be sluggish, deep breathing, with tremor-like muscular spasms and loss of coordination. The symptoms progressed to salivation and convulsions followed by the death of all three animals. Similar, but milder clinical signs were evident in the lower dosage groups. In victims, petechial haemorrhages or congestion was observed in the lungs. This was accompanied with mottled livers, slightly speckled and congested kidneys and distended and liquid or gas-filled intestines and stomachs. Nothing remarkable was seen in survivors.

The key study for acute dermal toxicity reports and LD50 value of 2.52 ml/kg (estimated to be equivalent to 2494 mg/kg bw) in rat in a reliable study conducted according to a protocol equivalent to guideline (Carnegie-Mellon 1976). Erythema, ecchymosis, scabs and desquamation were evident at application site with no other reported clinical signs. In victims, livers were paled and mottled, spleens dark and kidneys congested. No remarkable findings were seen in survivors.

No reliable data are available for acute inhalation, however a supporting study to which no reliability could be assigned reported no effects after an 8 hour exposure to 'substantially saturated vapour' (Carnegie-Mellon 1976). 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 – oral endpoint
The selected study is the only acute oral toxicity study available for the registered substance. It was conducted according to a protocol that is similar to OECD test guidelines but pre-dated GLP.

Justification for selection of acute toxicity – dermal endpoint
The selected study is the only acute dermal toxicity study available for the registered substance. It was conducted according to a protocol that is similar to OECD test guidelines but pre-dated GLP.

Justification for classification or non-classification

Based on the available information 3 -(triethoxysilyl)propanethiol is not classified for acute toxicity in accordance with Regulation (EC) No 1272/2008.