Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Oral: LD = 1400 mg/kg body weight leading to classification into CLP Acute Toxicity Hazard Category 4
Dermal: LD50 > 2000 mg/kg body weight leading to not classification according to CLP
Inhalation: no information available

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
1 400 mg/kg bw
Quality of whole database:
Only one study is available. This study is similar to OECD TG 401 and is reliable with restrictions.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
Only one study is available. This study is similar to OECD TG 402 and reliable with restrictions. .

Additional information

- oral toxicity:

The substance 4'-methylacetophenone is slightly acutely toxic when applied via oral route. The LC50 value is 1400 mg/kg body weight (Kretchmar 1971).

- dermal toxicity:

The substance 4'-methylacetophenone is not acutely toxic in a reliable and valid acute dermal toxicity study in rabbits. LD50 value > 2000 mg/kg body weight (Kretchmar 1971).

- inhalation toxicity:

Information about the acute inhalation toxicity of the substance is not available.

Dermal and oral routes of exposure are considered to be the most likely routes of human exposure to this fragrance substance. Overall, the registration item exhibits acute toxicity via oral route and no acute toxicity via dermal route.


Justification for selection of acute toxicity – oral endpoint
Only one study is available.

Justification for selection of acute toxicity – dermal endpoint
Only one study is available

Justification for classification or non-classification

- oral toxicity:

The observed acute oral toxicity of 4'-methylacetophenone and the derived LD50 values fall into the range between 300 and 2000 mg/kg bw. Accordingly 4'-methylacetophenone needs to be classified as "R22 Harmful if swallowed" according to Council Directive 2001/59/EC (28th ATP of Directive 67/548/EEC) and Category 4, "Warning - H302: Harmful if swallowed" according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.

- dermal toxicity:

Based on the above stated assessment of the acute dermal toxicity, 4'-methylacetophenone 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.

- inhalation toxicity:

No inhalation studies are available.