Butane-1,4-diol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 433 draft (Acute Inhalation Toxicity: Fixed Concentration Procedure) (not officially approved)

GLP compliance:

not specified

Test type:

fixed concentration procedure

Test material

Test material information

Constituent 1

Reference substance name:

Butane-1,4-diol

EC Number:

203-786-5

EC Name:

Butane-1,4-diol

Cas Number:

110-63-4

Molecular formula:

C4H10O2

IUPAC Name:

butane-1,4-diol

Details on test material:

- Analytical purity: 99.7%
- Impurities (identity and concentrations): Water, 2-methyl-1,5-pentanediol, 1,6 hexanediol, tetrahydrofural butanediol acetal, and undefined low and high boilers

Test animals

Species:

rat

Strain:

other: Crl:CD

Sex:

male

Details on test animals or test system and environmental conditions:

Rats were 7-8 weeks old and weighing between 233 and 271 grams. Male albino Crl:CD@ rats were housed in pairs in 8" x 8" x 14" stainless steel wire mesh cages. Purina Certified Rodent Chow@ 15002 and water were available ad libitum. Rats were weighed and observed for general suitabilityfor at least 1 week prior to test. Animals were restrained in stainless steel holders.

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

not specified

Details on inhalation exposure:

Rats were exposed nose-only to atmospheres containing refined 1,4-butanediol for single, 4h periods.

Analytical verification of test atmosphere concentrations:

yes

Remarks:

At 30-minute intervals, calibrated volumeS of test atmosphere were drawn through pre-weighed glass fiber filters. Filters were weighed both wet and dry on a Cahn 26 Automatic Electrobelance@ . Atmospheric concentrations were determined from dry weight ga

Duration of exposure:

4 h

Concentrations:

4.6 mg/L, 9.4 mg/L and 15 mg/L

No. of animals per sex per dose:

Summary reports 6 male rats whereas experimental detail reports 10.

Control animals:

no

Details on study design:

Duration of observation period following administration: 14 days
- Frequency of observations and weighing:daily
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: yes

Statistics:

LC 50 Calculated by the method of Finney, D. J., Probit Analysis, 3rd Edition, Cambidge University Press (1971)

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LC50

Effect level:

> 15 mg/L air

Exp. duration:

4 h

Remarks on result:

other: Mortality 1/10, 1 day post exposure

Effect levels 2

Key result

Sex:

male

Dose descriptor:

discriminating conc.

Effect level:

9.4 mg/L air

Exp. duration:

4 h

Remarks on result:

other: Mortality 0/10

Effect levels 3

Sex:

male

Dose descriptor:

other: No Observed Adverse Effects

Effect level:

4.6 mg/L air

Exp. duration:

4 h

Remarks on result:

other: Mortality 0/10

Mortality:

at 15mg/L 1/10 1day post exposure

Clinical signs:

other: During Exposure: Clinical observations could not be made due to the density of chamber atmospheres. When removed from restrainers, all rats exposed to 9.4 and 15 mg/L exhibited lethargic or no movement and labored breathing. At 15 mg/L, rats exhibited red

Body weight:

In a dose dependent manner, all rats exhibited slight to severe weight loss 1 day post exposure, followed by the resumption of a normal rate of weight gain.

Gross pathology:

no data

Any other information on results incl. tables

An inhalation LC50 of refined 1,4-butanediol could not be calculated from these data as there was only 1/10 mortality at highest dose tested. Higher atmospheric concentrations could not be generated.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU