Registration Dossier

Administrative data

Description of key information

In a valid study an oral LD50 (male rats) = 3227 mg/kg bw; LD50 (female rats) = 3860 mg/kg bw) was found. the result is supported by several no assignable studies by a weight of evidence consideration.
In a valid acute dermal toxicity study rats received a single application of 1 ml/kg bw (highest applied dose) for 24 hours. During exposure the application was covered with plaster backed with aluminium foil. The LD50 was > 1.08 mg/kg bw (rat). In 2 not assignable studies (secondary literature) on rabbits a LD 50 > 2165 mg/kg bw and LD50 > 7940 mg/kg bw was determined.
In a valid inhalation study rats were exposed to 4 different concentrations to vapour of o-chlorotoluene for 4 hours. A LC50 = 7719 ppm (ca. 37.517 mg/l), male rats was found. A further valid study on rats and mice was conducted. In both species no death occurred when exposed to 20.583 mg/l air for 1 hours.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
3 227 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
LC50
Value:
37.5 mg/m³

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
discriminating dose
Value:
1.08 mg/kg bw

Additional information

The LD50 for acute oral toxicity is > 3227 mg/kg bw and by a weight of evidence consideration the LD50 for acute dermal toxicity is > 2000 mg/kg bw.

For acute inhalation toxicity a LD50 = 37.5 mg/l (rat, male) was found. In an additional inhalation study male rats and mice were exposed for 1 hour to 20.583 mg/l of the test substance. None of the animals died.

Justification for classification or non-classification

Due to the results of the acute oral and dermal toxicity studies a classification is not justified.

According to Annex I to Directive 67/548/EEC 2-chlorotoluene is classified as Xn, R20 (harmful by inhalation);

GHS: acute tox. 4, H331: Toxic if inhaled.

This classification will be adopted