Cyclopropyl methyl ketone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

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 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

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
- Weight at study initiation: 200-300 g
- Housing: individually
- 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: 04.11.1997 To: 20.11.1997

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsolumbar region
- % coverage: 10
- Type of wrap if used: gauze bandaging secured with a semiocclusive dressing encircled firmly around the trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water and absorbent paper
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations (mortality, clinical signs): at 30 minutes after dosing and at hourly intervals of day 0 and once daily thereafter
- Frequency of weighing: day 0 (prior to dosing), day 7 and day 14
- 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:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths to treatment.

Clinical signs:

other: Directly after application all animals showed defence reactions and vocalisations. 30 minutes later until the end of the study no more signs of systemic reaction to treatment were observed.

Gross pathology:

The macroscopical examination on day 14 revealed no abnormalities.

Other findings:

No local dermal irritations at the treatment site were observed following removal of the dressings until the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The acute lethal dermal dose to rats of the test item was found to be greater than 2000 mg/kg bodyweight.