Registration Dossier

Administrative data

Description of key information

Oral:  LD50 rat = 738 mg/kg bw
Dermal: LD50 rat/rabbit > 2000 mg/kg bw
Inhalation: DNEL (inhalation, short-term, systemic effects) = 0.0518 mg/m3

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
738 mg/kg bw

Acute toxicity: via dermal route

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

Additional information

An acute oral LD50 study in the rat demonstrated that the test material was moderately toxic (LD50 = 738 mg/kg) when administered via the oral route (Jones 1983). The LD50 was >2000 when applied to rats or rabbits via the dermal route, indicating the test material has dermal toxicity (Allen 1993; Nelson et al., 1977). An acute inhalation study is not warranted because an acute inhalation DNEL may be derived from the chronic oral toxicity study by Ciafalo (1992).

Justification for classification or non-classification

The GHS criteria for classifying a substance as Category 4 acute toxicity hazard is triggered when the acute toxicity estimate is between 300 and 2000 mg/kg body weight. Since the LD50 is 738 mg/kg body weight, the test material is within range for classification as a Category 4 acute toxicity hazard. See: Regulation (EC) No 1272/2008; See Official Journal of the European Union, (2008) Vol. L353, pp. 1-1355, at p. 81.

The GHS criteria for classifying a substance as a Category 4 acute toxicity hazard via the dermal route are between 1000 and 2000 mg/kg body weight. Since the LD50 via the dermal route was greater than 2000 mg/kg body weight, the test substance does not meet the criteria necessary for classification as an acute toxicity hazard via the dermal route. See: Regulation (EC) No 1272/2008; See Official Journal of the European Union, (2008) Vol. L353, pp. 1-1355, at p. 81