Butanone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation, for read-across substance

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

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

Version / remarks:

-reliability scoring was based on 2001 guideline

Deviations:

yes

Remarks:

-insignificant deviation, guideline suggests using animals of all the same sex; no necropsy conducted

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butan-2-ol

EC Number:

201-158-5

EC Name:

Butan-2-ol

Cas Number:

78-92-2

Molecular formula:

C4H10O

IUPAC Name:

butan-2-ol

Details on test material:

- Name of test material (as cited in study report): Secondary Butyl Alcohol
- Physical state: colourless, clear liquid
- Analytical purity: 99.5%
- Expiration date of the lot/batch: one calendar month from the date of issue
- Lot/batch No.: Indent 9200/9530
- Stability under test conditions: Test substance was judged to have been stable for the duration of this study.
- Storage condition of test material: Following its arrival in compound control this test substance was stored in the dark at ambient temperature.

Test animals

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River U.K. Ltd.
- Age at study initiation: 9 to 11 weeks old
- Weight at study initiation: Weight on Day 1 = 189 to 219 g (males) and 125 to 149 g (females)
- Fasting period before study: Fasted overnight (18 h) prior to dosing.
- Housing: Two days before dosing, the rats to be used were housed in groups of 2 or 3 animals of the same sex per cage.
- Diet (e.g. ad libitum): Food (PRD, Labsure Animal Foods, Dorset), ad libitum
- Water (e.g. ad libitum): Filtered but untreated water from the public supply, ad libitum
- Acclimation period: not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): air temperature was 19 to 25 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: not reported

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Range finding studies were performed.

Doses:

950, 1200, 1500, 2000, and 2400 mg/kg

No. of animals per sex per dose:

5 rats/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rats were observed for clinical signs over 14 days. Body weight measurements were recorded on Days 1, 7, and 14.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight

Statistics:

Acute oral LD50 values were calculated using probit analysis (Finney, 1977).

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

2 054 other: mg/kg

Remarks on result:

other: 95% fiducial limits were 1283 - 4018 mg/kg

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

2 328 other: mg/kg

Remarks on result:

other: 95% fiducial limits were 1470 - 5428 mg/kg

Effect levels 3

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 193 other: mg/kg

Remarks on result:

other: 95% fiducial limits were 1608 - 4146 mg/kg

Mortality:

Over the 14-day observation period, 0, 1, 2, 1, and 8 animals died in the 950, 1200, 1500, 2000, and 2400 mg/kg dose groups, respectively. For more details, refer to Table 1 (attached).

Clinical signs:

other: All rats at all dose levels had gait and/or posture abnormalities. In the higher dose groups some rats were comatose or prostrate within a few hours of dosing, with some animals being unconscious for 24 hours or more. Some rats in the top dose group (2400

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met