Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

NOAEL reproductive toxicity Tris(ethyl acetoacetato-O1',O3)aluminium= 239 mg/ kg bw/day

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
239 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Studies conducted according to internationally accepted testing guidelines.
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

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

NOEL reproductive toxicity > 1000 mg/kg bw/day (males) and NOEL= 225 mg/kg bw/day (females) for similar substance 1 and recalculated for Tris(ethyl acetoacetato-O1',O3)aluminium, considering the lowest value for females, is 239 mg/kg bw/day.

NOAEL reproductive toxicity for similar substance 2 is 27 mg/kg bw/day and recalculated for Tris(ethyl acetoacetato-O1',O3)aluminium is 414 mg/kg bw/day.

Based on precautionary principle the lowest value of NOAEL, i.e. NOAEL (reproductive toxicity) = 239 mg/kg bw/day, was chosen to assess the reproductive toxicity of Tris(ethyl acetoacetato-O1',O3)aluminium.

Effects on developmental toxicity

Description of key information

NOAEL developmental toxicity Tris(ethyl acetoacetato-O1',O3)aluminium= 239 mg/ kg bw/day

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
239 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Studies conducted according to internationally accepted testing guidelines.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

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

NOEL developmental toxicity = 225 mg/kg bw/day for similar substance 1 and recalculated for Tris(ethyl acetoacetato-O1',O3)aluminium is 239 mg/kg bw/day.

NOAEL developmental toxicity for similar substance 2 is 26 mg/kg bw/ day and recalculated for Tris(ethyl acetoacetato-O1',O3)aluminium is 400 mg/kg bw/day.

Based on precautionary principle the lowest value of NOAEL, i.e. NOAEL (developmental toxicity) = 239 mg/kg bw/day, was chosen to assess the developmental toxicity of Tris(ethyl acetoacetato-O1',O3)aluminium.

Justification for classification or non-classification

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

Additional information