Registration Dossier

Administrative data

Description of key information

The key study for acute oral toxicity determined an LD50 in the rat of >2000 mg/kg bw in a reliable study conducted in compliance with the now deleted OECD 401 but without GLP status (Hüls AG, 1989).
The key study for acute dermal toxicity determined an LD50 in the rabbit of 2.52 mg/kg bw (2293 mg/kg bw based on a relative density of 0.91) in a reliable study similar to OECD 402, with limited information and without GLP (Mellon Institute, 1956). Corrosive effects on the skin were apparent.
There are no reliable inhalation studies.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
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:
adverse effect observed
Dose descriptor:
LD50
Value:
2 293 mg/kg bw

Additional information

There are two acute oral toxicity studies available for 3-(diethoxymethylsilyl)propylamine. Although neither study was conducted to GLP, the study that was chosen as the key study appeared to be more comparable with OECD TG 401, and was better reported. The key study (Hüls AG, 1989) reported an LD50 in the rat of >2000 mg/kg bw in a study conducted according to a test protocol appropriate for the time but without GLP. One male and one female died between 5 minutes and 48 hours after treatment. Clinical signs included adoption of a prone or squatting position, ruffled fur, altered mobility, diarrhoea or nasal bleeding. All survivors were symptom-free after 48 hours.

There is one reliable study for the dermal route, although this has limitations in the level of detail reported, it is deemed to be comparable to an OECD TG 402 study. This key study, similar to OECD 402 but not conducted according to GLP, reported an LD50 of 2.52 ml/kg bw (2293 mg/kg bw based on a relative density of 0.91). Animals treated at 4.0 ml/kg bw died within four days of exposure; one animal in the 2.0 ml/kg bw group died on day three after exposure. Corrosive effects to the skin were apparent.

There are no reliable data for the inhalation route. In accordance with Column 2 of REACH Annex VIII, an acute inhalation toxicity study (required in Section 8.5.2) does not need to be conducted as the substance is classified as corrosive.


Justification for selection of acute toxicity – oral endpoint
The selected study was the best quality acute oral toxicity study that was available for the registration substance. It was conducted according to a protocol similar to the now-deleted OECD 401, but was not compliant with GLP.

Justification for selection of acute toxicity – inhalation endpoint
No reliable acute inhalation toxicity data are available.

Justification for selection of acute toxicity – dermal endpoint
The selected study is the only available acute dermal toxicity study for the registration substance. It was conducted according to a protocol similar to OECD 402 but was not compliant with GLP.

Justification for classification or non-classification

Based on the available information on the registered substance, no classification is proposed for acute toxicity in accordance with Regulation (EC) No 1272/2008.