Registration Dossier
Registration Dossier
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EC number: 219-847-4 | CAS number: 2550-26-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 278 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Only one, but reliable study for acetophenone is available.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
There is no reproductive toxicity data on 4-phenylbutan-2-one.
- Justification for read across: Acetophenone is a similar compound to 4-phenylbutan-2-one, having two additional carbons in the substitution chain of benzene ring. The both compounds undergo similar oxidation to aromatic acid and subsequently conjugation pathway, therefore it is possible to use experimental data on acetophenone for read across as described in the Read Across Justification (see section 13).
In a reproduction/developmental screening study with acetophenone (Thorsrud, 2003), NOAEL for reproductive effects was determined at 225 mg/kg bw/day (278 mg/kg bw/day 4-phenylbutan-2-one, conversion factor 1.23). Since the NOAEL for systemic parental toxicity was considered 225 mg/kg bw/day (278 mg/kg bw/day 4-phenylbutan-2-one) as well, it is concluded that acetophenone (4-phenylbutan-2-one) does not need to be classified as reproductive toxicant.
Short description of key information:
Oral: NOAEL (Parental for systemic toxicity and reproductive effects) = 278 mg/kg bw/day 4-phenylbutan-2-one (data derived from acetophenone study with NOAEL = 225 mg/kg bw/day)
Oral: LOAEL (Parental for systemic toxicity and reproductive effects) = 925 mg/kg bw/day 4-phenylbutan-2-one (data derived from acetophenone study with LOAEL= 750 mg/kg bw/day)
Inhalation: no data
Dermal: no data
Justification for selection of Effect on fertility via oral route:
Only one reliable study for acetophenone is available and was taken as read across to 4-phenylbutan-2-one.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of Effect on developmental toxicity: via oral route:
not required
Justification for selection of Effect on developmental toxicity: via inhalation route:
not required
Justification for classification or non-classification
- Reproductive toxicity:
Based on the above stated assessment of the reproduction toxicity potential of 4-phenylbutan-2-one is deemed not to be toxic to the reproduction and accordingly does not need to be classified according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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