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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