Registration Dossier

Administrative data

Description of key information

The tests were performed according to the following methods: 
Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
Method B.3 Acute Toxicity (Dermal), Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008
Both: GLP study
No data for acute inhalation toxicity are available.

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Acute toxicity: via dermal route

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

Additional information

Acute oral toxicity

The test substance administered at thedose of 2000 mg/kgcaused no death of animals.   No clinical signs of intoxication were observed during study in all six animals. No pathologic macroscopic changes were diagnosed during pathological examination. According to the study results the value of LD50of the test substance for female rats is higher than 2000 mg/kg of body weight.

Acute dermal toxicity

The test substance applied at the dose of 2000 mg/kg of body weight did not cause death of animals. No clinical signs of intoxication were observed in all animals. No macroscopic change was diagnosed during pathological examination in all animals. According to the results of study, the value of LD50 (dermal) of the test substance, Ashes (residues) – Biomass Combustion, for rats of both sexes is higher than 2000 mg/kg of body weight.

Acute inhalation toxicity

The test of acute inhalation toxicity was not carried out by reason that dermal exposure by dust of the test material was more probable than exposure by inhalation.

Justification for classification or non-classification

Based on the test results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations the test substance did not fall into any of quoted categories of toxicity both oral and dermal, and has no obligatory labelling requirement in this respect.