Registration Dossier

Administrative data

Description of key information

Acute toxicity:
Oral - LD50 - ca. 3200 mg/kg
Dermal - LD50 - > 2000 mg/kg

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
Value:
5 410 mg/kg bw

Acute toxicity: via dermal route

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

Additional information

Acute oral toxicity has been investigated using methods similar to those described in OECD/EU test guidelines. The LD50 following administration of a single oral dose to rats was approximately 3200 mg/kg body weight. A value of 5410 mg/kg body weight is reported, in a peer reviewed handbook.

Acute dermal toxicity has been investigated in accordance with OECD/EU test methods. A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for 24 hours. No toxicity occurred and the lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg.

Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. It is accepted that if >1% of a sample has a particle size <50 μm inhalation testing should be considered as this could be an exposure route of concern. Particle size analysis indicates that no particulate matter in the substance as manufactured and used is of an inhalable size and testing is therefore not justified.

Justification for classification or non-classification

Non classification justified by lack of observed toxicity in acute single exposure studies by oral and dermal routes.