Registration Dossier
Registration Dossier
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EC number: 239-343-8 | CAS number: 15306-17-9
Endpoint summary
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
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