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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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