4'-methylacetophenone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study following principles similar to those of OECD TG 402

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4'-methylacetophenone

EC Number:

204-514-8

EC Name:

4'-methylacetophenone

Cas Number:

122-00-9

Molecular formula:

C9H10O

IUPAC Name:

1-(4-methylphenyl)ethanone

Details on test material:

- Name of test material (as cited in study report): RIFM-UF-P70
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation: 2.50-3.10 kg
- Fasting period before study: no
- Housing: individually in hanging rabbit cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least seven days prior to testing

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: backs
- % coverage: 30 % of the total body surface area
- Type of wrap if used: impervious plastic sheeting

REMOVAL OF TEST SUBSTANCE
- Washing (if done): all residual test material was removed
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg bw

Duration of exposure:

24 hours

Doses:

2.0 g/kg bw

No. of animals per sex per dose:

2

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily and initial and final body weights were recorded
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died during the observation period of 14 days.

Clinical signs:

No untoward behavioral reactions were exhibited by any of the animals following dermal exposure to the samples of fragrance raw material.

Gross pathology:

No gross pathologic alterations were noted.

Other findings:

- Other observations: Pale red erythema and slight edema were noted after 24 hours. By seven days, dryness was evident. Dryness persisted to the end of the 14-day observation period.

Any other information on results incl. tables

Test material: RIFM-UF-P70

Acute Dermal Toxicity – Albino Rats

Mortality and Body Weight Data

Dose (g/kg)	Animal Number and Sex	Individual Body Weight (kg) Test Day Number:		Number Dead/Number Tested	Percent Dead
		0	14
2.0	1-M	2.60	2.82	0/4	0
	2-M	3.10	3.50
	3-F	2.84	2.78
	4-F	3.04	3.22

 

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance was acutely non toxic to rabbits in an acute dermal toxicity test with an LD50 value >2.0 g/kg bw. The substance is not classified according to CLP.

Executive summary:

The acute dermal toxicity of the test substance 4'-methylacetophenone was studied in a non-GLP test according to principles slightly deviating from those of current guidelines. Group of four animals (two males and two females) was exposed to single dermal dose of 2.0 g/kg bw. Animals were observed during a period of 14 days. No mortality was observed under this dosing regime. The LD50 value was calculated as >2.0 g/kg bw. Local skin reactions were pale red erythema and slight edema after 24 hours, as well as dryness, which persisted to the end of the 14 -day observation period.