4'-methylacetophenone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study in accordance with principles similar to those of relevant OECD TG 401

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 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

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:

rat

Strain:

Sprague-Dawley

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: 150-208 g
- Fasting period before study: 16 hour
- Housing: in stock cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

0.6, 0.9, 1.4, 2.0, 3.0 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, at the beginning and at the end
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology.

Statistics:

At the end of the observation period, the acute oral median lethal doses (LD50) of the test materials were calculated using the techniques of Weil, Thompson, and Thompson and Weil.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 400 mg/kg bw

Based on:

test mat.

95% CL:

1 100 - 1 700

Mortality:

In the low-dose group, no animal died during the observation period of 14 days. In 0.9 g/kg bw dose group, one rat male died on day two following oral (gavage) exposure. In 1.4 g/kg bw dose group, one rat male died on day two and one rat female died on day three following oral (gavage) exposure. In 2.0 g/kg bw dose group, two rats males and one female died on day three following oral (gavage) exposure. In 3.0 g/kg bw dose group, two rats males died on day two and two rats females died on day one and on day three following oral (gavage) exposure.

Clinical signs:

In dose groups from 0.6 to 1.4 g/kg bw, hypoactivity, muscular weakness and ruffed fur were observed, whereas in dose group of 2.0 g/kg bw, additionally diarrhea and in dose group of 3.0 g/kg bw, prostration were observed.

Gross pathology:

Necropsy of the animals that died revealed pale livers and hemorrhages in the stomachs. Hemorrhages were also noted at sacrifice in the stomach of one animal (1.4 g/kg level). No other gross pathologic alterations were noted.

Any other information on results incl. tables

Test material: RIFM-UF-P70

Acute Oral Toxicity – Albino Rats

Mortality and Body Weight Data

Dose (g/kg)	Animal Number and Sex	Individual Body Weight (g) Test Day Number:		Number Dead/Number Tested	Percent Dead
		0	14
0.6	1-M	201	226	0/4	0
	2-M	200	238
	3-F	173	228
	4-F	196	252
0.9	5-M	164	246	1/4	25
	6-M	186	(2 days)
	7-F	151	180
	8-F	171	214
1.4	9-M	165	271	2/4	50
	10-M	186	(2 days)
	11-F	174	196
	12-F	180	(3 days)
2.0	13-M	204	(3 days)	3/4	75
	14-M	202	(3 days)
	15-F	153	(3 days)
	16-F	162	212
3.0	17-M	198	(2 days)	4/4	100
	18-M	194	(2 days)
	19-F	173	(6-22 hours)
	20-F	168	(3 days)

Test material: RIFM-UF-P70

Acute Oral Toxicity – Albino Rats

Summary of Reactions

Dose (g/kg)	Reaction	Time of Onset Following Dose Administration	Duration of Reaction	Time of Death Following Dose Administration
0.6	Hypoactivity	½ hour	2 days	-
	Muscular weakness	2 hours	1 day
	Ruffed fur	6-22 hours	1 day
0.9	Hypoactivity	½ hour	3 days	2 days
	Muscular weakness	2 hours	2 days
	Ruffed fur	6-22 hours	2 days
1.4	Hypoactivity	½ hour	5 days	3 days
	Muscular weakness	2 hours	3 days
	Ruffed fur	2 hours	5 days
	Diarrhea	2 hours	2 days
3.0	Hypoactivity	½ hour	Until death	6 hours – 3 days
	Muscular weakness	2 hours
	Ruffed fur	2 hours
	Diarrhea	2 hours
	Prostration	5 hours

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance was acutely toxic to rats in an acute oral toxicity test with a LD50 value of 1400 mg/kg bw. The substance is classified into Acute Toxicity Category IV according to CLP.

Executive summary:

The acute oral toxicity of the test substance 4'-methylacetophenone was studied in a non-GLP test according to principles slightly deviating from those of current guidelines. Groups of four animals (two males and two females) were exposed to single oral (gavage) doses of 0.6, 0.9, 1.4, 2.0 and 3.0 g/kg bw. Animals were observed during a period of 14 days. No mortality was observed in the low dose group, whereas one, two, three and four animals died respectively in 0.9, 1.4, 2.0 and 3.0 g/kg bw dose groups. The LD50 value was 1.4 g/kg bw with a standard deviation of 0.3 g/kg bw. Hypoactivity, muscular weakness and ruffed fur were observed in all dose groups, whereas diarrhea was observed additionally in 2.0 and 3.0 g/kg bw dose groups and prostration only in 3.0 g/kg dose group.