Butan-2-ol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1954

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study without detailed documentation.

Data source

Reference

Reference Type:

publication

Title:

RANGE FINDING TOXICITY DATA PT. V (5)

Author:

Smyth HF, Carpenter CP, Weil CS & Pozzani UC

Year:

1954

Bibliographic source:

AMA Arch Ind Hyg Occup Med (1954) 10(1):61-68

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Version / remarks:

- Reliability scoring based on 2009 guideline

Deviations:

yes

Remarks:

-housing and diet information, strain, time of death, body weight and necropsy findings not reported; exposure period was not 7 hr; concentration not verified; < 10 animals tested

GLP compliance:

no

Remarks:

Study pre-dates GLP

Test type:

standard acute method

Limit test:

yes

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): Butanol-2

Test animals

Species:

rat

Strain:

not specified

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: Not reported.
- 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.

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

not specified

Vehicle:

other: no data

Details on inhalation exposure:

Inhalation of known vapor concentrations by rats is conducted with flowing streams of vapors prepared by various styles of proportioning methods. Exposures are 4 hours long. Concentrations are in an essentially logarithmic series with a factor of two, and data for the concentration yielding fractional mortality among six rats within 14 days are presented. Where no fractional mortality was observed, both the concentration yielding no mortality and that yielding complete mortality are indicated.

Analytical verification of test atmosphere concentrations:

no

Remarks:

Nominal concentrations are recorded, not confirmed by analytical methods.

Duration of exposure:

4 h

Concentrations:

16000 ppm

No. of animals per sex per dose:

6 males in total

Control animals:

not specified

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.

Statistics:

Not required for acute studies.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

other: Mortality in 14 days following exposure

Effect level:

16 000 ppm

Exp. duration:

4 h

Mortality:

5/6 animals died within 14-day observation period.

Clinical signs:

other: Not reported.

Body weight:

Not reported.

Gross pathology:

Not reported.

Other findings:

Not reported.

Applicant's summary and conclusion

Interpretation of results:

other: unable to classify with the data presented

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.