Cyclopropyl methyl ketone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Cyclopropyl methyl ketone

EC Number:

212-146-4

EC Name:

Cyclopropyl methyl ketone

Cas Number:

765-43-5

Molecular formula:

C5H8O

IUPAC Name:

1-cyclopropylethan-1-one

Test material form:

other: liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: healthy, young adult animals
- Fasting period before study: 16 hours. 3 hours after application food was offered ad libitum.
- Housing:max. 5 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 08.09.1997 To: 23.10.1997

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

In the first step three male rats were given a single oral application of the test substance at a limit-dose of 2000 mg/kg bodyweight. No rats died after the treatment, so three female rats were treated in the same way. Since mortalities occurred in two females, three male rats were treated with the dose
level of 200 mg/kg bw. No mortalities were observed in the animals after administration of this dose. Therefore three female rats were treated in the
same way.
The dosing formulation was applied to the rats by gavage using a stomach tube (2.23 cm3/kg for 2000mg/kg and 0.22 cm3/kg for 200 mg/kg bodyweight).

Doses:

200 and 2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: soon after dosing and 1, 2, 3, 4, 5 and 6 h after dosing and once daily thereafter
- Frequency of weighing: day 0 (prior to dosing), day 7, day 14 or after death of an animal
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 500 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

2000 mg/kg bw: 0/3 male animals, 2/3 female animals
200 mg/kg bw: 0/3 male animals, 0/3 female animals
500 mg/kg bw: 0/3 male animals, 0/3 female animals

Clinical signs:

other: Male animals dosed with 2000 mg/kg bw, showed moderate to severe clinical signs on the day of treatment. Half an hour until 6 hours p.a. signs like sedation, abdormal and lateral position, paddling movements, vocalisation, difficult and hurried breathing,

Gross pathology:

The macroscopical examination of the deceased two female animals dosed with 2000 mg/kg bw revealed autolytic changes of all tissues. The surviving female showed agglutinations of tissues of the addominal cavity (liver, spleen, pancreas and stomach).
All male animals dosed with 2000 mg/kg bw and all male/female animals dosed with 200 mg/kg bw showed no macroscopical abnormalities.

Any other information on results incl. tables

Amendment to the final report:

In an amendment to the final report an experiment with the dose group 500 mg/kg bw was reported.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Remarks:

Migrated information

Conclusions:

In this oral toxicity study in the rat an LD50 between 500 and 2000 mg/kg bw was found for the test item.