Registration Dossier

Administrative data

Description of key information

Repeated oral dose toxicity was performed in accordance with the method:Method B.26 Sub-Chronic Oral Toxicity Test: Repeated Dose 90-day Oral Toxicity Study in Rodents, Council Regulation (EC) No. 440/2008, Published in O.J. L142, 2008
GLP study

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
400 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Additional information

The value of NOAEL (No Observed Adverse Effect Level) for males and females is 400 mg/kg/day. The value was established on the basis of haematology, urinalysis and histopathological examination.

No studies on repeated dose dermal toxicity and repeated dose inhalation toxicity of test substance are available.

Justification for classification or non-classification

The data from Study No. 3/10/8: Ashes (residues) – Biomass Combustion-Repeated Dose 90-day Oral Toxicity Study are of acceptable quality for classification of substances for STOT RE.

The values of NOAEL was used in weight of evidence approach based on a comparison with classification criteria.

The Guidance Values (dose/concentration) for STOT RE Category 1 is C ≤ 10 mg/kg body weight/day, the Value Ranges (dose/concentration) for STOT RE Category 2 is 10 < C ≤ 100 mg/kg body weight/day for oral route exposure (Regulation (EC) No.1272/2008).

The lowest value of NOAEL (400 mg/kg body weight/day) is above the Guidance Values and Range (C).