Registration Dossier

Administrative data

Description of key information

NOAEL Tris(ethyl acetoacetato-O1',O3)aluminium(repeated oral toxicity rat 28 days) = 798 mg/kg bw/day

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
798 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Study conducted according to internationally accepted testing guidelines.

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

For the assessment of oral repeated dose toxicity of Tris(ethyl acetoacetato-O1',O3)aluminium a read-across approach was used based on the information available for similar substance 1 and for similar substance 2 (see read-across justification in section 13 of this IUCLID dossier).

NOEL similar substance 1 (repeated oral toxicity rat 28 days) = 1000 mg/kg bw /day and recalculated for Tris(ethyl acetoacetato-O1',O3)aluminium is 1062.5 mg/kg bw/day

NOAEL similar substance 2 (repeated oral toxicity rat 28 days) = 52 mg/kg bw/day and recalculated for Tris(ethyl acetoacetato-O1',O3)aluminium is 798 mg/kg bw/day.

Based on precautionary principle the lowest value of NOAEL, i.e. NOAEL (repeated oral toxicity rat 28 days) = 798 mg/kg bw/day, was chosen to assess the oral repeated dose toxicity of Tris(ethyl acetoacetato-O1',O3)aluminium.

Justification for classification or non-classification

Tris(ethyl acetoacetato-O1',O3)aluminium is not classified for repeated dose toxicity according to the CLP Regulation (EC.n.1272/2008). For justification see the results of available studies.