N-butyl acetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Was not conducted under GLP but has sufficient data for interpretation of results.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

N-butyl acetate

EC Number:

204-658-1

EC Name:

N-butyl acetate

Cas Number:

123-86-4

Molecular formula:

C6H12O2

IUPAC Name:

butyl acetate

Details on test material:

- Name of test material (as cited in study report): N-Butyl Acetate
- Physical state: liquid
- Analytical purity: as n-butyl acetate is usually available as high quality / purity, it can probably be assumed that test item purity was high

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2 to 3 kg
- Diet: commercial available diet, ad libitum
- Water: municipal water, ad libitum

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

REMOVAL OF TEST SUBSTANCE
- excess fluid is removed to diminish ingestion

Duration of exposure:

24 hours

Doses:

16.0 mL/kg

No. of animals per sex per dose:

5 rabbits per sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1 hour, day 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Statistics:

LD50's and the estimated LD50 slopes are calculated by the moving average method (Thompson, 1947; Weil, 1983).

Results and discussion

Preliminary study:

none.

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

16 mL/kg bw

Remarks on result:

other: (16 mL/kg calculated 14112 mg/kg, based on specific gravity of 0.882; none of the animals died during the 14 days observation period)

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 16 mL/kg bw

Remarks on result:

other: none of the animals died during the 14 days observation period

Mortality:

16 mL/kg - 0/5 rabbits, both sexes.

Clinical signs:

other: Male: No signs of toxicity. Ecchymosis at 1 day; erythema at 1 to 7 days; edema, necrosis at 1 to 14 days; fissuring at 7 days; desquamation at 7 to 14 days; scabs, ulcerations, alopecia at 14 days. Female: Diarrhea in 1 at 14 days; emaciation in 1 at 14

Gross pathology:

Male: Lungs light pink to dark red.
Female: Lungs mottled light to dark red; intestines of 1 gas-filled.

Other findings:

None.

Any other information on results incl. tables

None.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

N-Butyl Acetate has an extremely low order of acute toxicity following single dermal application. The dermal LD0 was > 16 mL/kg (calculated 14112 mg/kg, based on specific gravity of 0.882) under the study conditions.

Executive summary:

N-Butyl Acetate was tested for dermal toxicity in rabbits (5 male and 5 female rabbits/dose) at a dose of 16.0 ml/kg and killed 0 of 5 rabbits/sex (during 14 days observation period). Based on the results obtained, the LD0 was 16 mL/kg (calculated 14112 mg/kg, based on specific gravity of 0.882) under the study conditions, the estimated LD50 thus was > 16 mL/kg (Myers et al. 1987).

This study was judged to be reliable (RL2) and therefore selected as key study.