Butanone

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1962

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study without detailed documentation.

Data source

Reference

Reference Type:

publication

Title:

Range-Finding Toxicity Data: List VI

Author:

Smyth H, Carpenter C, Weil C, Pozzani U, & Striegel J

Year:

1962

Bibliographic source:

AMER-IND-HYG-ASSN-J. 23. 95-107, 1962

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Missing information on test material, test animals, housing conditions, diet, environmental conditions, dermal exposure, vehicle, doses, examinations and measurements. No individual results were reported

GLP compliance:

no

Remarks:

Study pre-dates GLP requirements

Test type:

other: Similar to the cuff method of Draize et al.

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butanone

EC Number:

201-159-0

EC Name:

Butanone

Cas Number:

78-93-3

Molecular formula:

C4H8O

IUPAC Name:

butan-2-one

Details on test material:

- Name of test material (as cited in study report): 2-butanone

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

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: 2.5 to 3.5 kg
- Fasting period before study: Not reported
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported


IN-LIFE DATES:Not reported

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: entire trunk
- % coverage: Not reported
- Type of wrap if used: Plastic film


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not reported
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Not reported
- Concentration (if solution): Not reported
- Constant volume or concentration used: yes
- For solids, paste formed: Not reported


VEHICLE
No information

Duration of exposure:

24 hours

Doses:

Not specifically reported. It is reported that, dosages greater than 20 ml/kg can not be retained in contact with the skin.

No. of animals per sex per dose:

4 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Not reported
- Necropsy of survivors performed: Not reported
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Not reported

Statistics:

LD50 was reported to be calculated

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 mL/kg bw

Mortality:

Not reported

Clinical signs:

other: Not reported

Gross pathology:

Not reported

Other findings:

Not reported

Any other information on results incl. tables

No tables or results presented

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

The work of this group pre-dates range finding toxicity guidelines and provided much of the basis for their development. Their results are cited by many subsequent authoritative review bodies and are often found in SIDS and SIAR documents via secondary references. Therefore, these results are deemed reliable.