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Administrative data

Description of key information

-Acute oral: several studies are available. The study of 1992 was choosen as key study because DOTE with a purity of 90% was used in this study (the others studies "klimisch 2" used DOTE with a purity smaller than 90% or DOTC).
-Acute dermal : two key studies were available.
-No information on acute inhalation toxicity was available.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
discriminating dose
2 000 mg/kg bw

Additional information

Acute oral :

A robust acute oral toxicity rat study (OECD guideline 401) was carried out with a mixture of DOT (2 -EHMA) and MOT(2 -EHMA) (90:10%). Two doses of 1000 and 2000 mg/kg bw were tested (single dose) with a 14 -days observation period. Animals in both dose groups exhibited clinical signs of toxicity and effects on mortality were observed. The LD50 was lower than 2000 mg/kg for female rats, the overall LD50 for males and females was 2000 mg/kg bw (lower 95% confidence limit= 1265 mg/kg/bw) ('Acute toxicity category 4' / H302, harmful if swallowed according to GHS).

Acute dermal :

A robust acute dermal toxicity rat study (OECD guideline 402) was carried out with a mixture of DOT(2 -EHMA) and Octyltin tris(2-EHMA) (90:10 % w/w).The test dose was 2000 mg/kg bw; the dose volume applied was 2  ml/kg bw.  After 24 hours, the exposed skin was cleaned and the area of application was observed for 14 days. Due to the lack of observed mortality, the 14-day acute dermal LD50s of the test substance were reported as: LD50 (both sexes) >2000 mg/kg bw.

An other study was carried out with a mixture of DOT (2 -EHMA) and MOT(2 -EHMA) (70:30%), the same result is observed : LD50 > 2000 mg/kg bw.

Acute inhalation : no study

Justification for classification or non-classification

Acute oral :

Based on the observed oral LD50 value, DOT(2 -EHMA) is classified with R22 according to Directive 67/548/EEC and 'Acute toxicity category 4' (H302, harmful if swallowed) according to Regulation EC No.1272/2008 (CLP). Justification : LD50 = 2000 mg/kg bw.

Acute dermal :

Based on the acute dermal toxicity study, classification is not warranted according to Directive 67/548/EEC and Regulation EC No.1272/2008 (CLP).

Justification : LD50> 2000 mg/kg bw.

Acute Inhalation : not classified be because no study