Butane-1,2-diol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 June 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Remarks:

Non-GLP, non-guidline with deviation from the curent guidelines

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

no guideline followed

Guideline:

other: Method according to Smyth et al. Am. Ind. Hyg. Ass. J. 23, 95-107, 1962

GLP compliance:

no

Test type:

other: standard acute inhalation method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Butane-1,2-diol

EC Number:

209-527-2

EC Name:

Butane-1,2-diol

Cas Number:

584-03-2

Molecular formula:

C4H10O2

IUPAC Name:

butane-1,2-diol

Test material form:

not specified

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Wiga, Sulzfeld
- Age at study initiation: Not reported
- Weight at study initiation: ca. 212 g
- Fasting period before study: Not specified.
- Housing: Not reported
- Diet (e.g. ad libitum): Altromin-R (Altrogge, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Not reported
ENVIRONMENTAL CONDITIONS : Not reported
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: Not reported

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

air

Details on inhalation exposure:

The product was placed in an approximately 5 cm high fritted glass bottle which was located in a water bath at 20°C. Through the product flows an air volume of 200 liters / hour. The vapor of the substance-enriched air stream was distributed to glass inhalation chambers. The exposure times were 3, 10 and 30 minutes and 1, 3 and 7 hours.

Analytical verification of test atmosphere concentrations:

not specified

Remarks on duration:

7 hours

Concentrations:

370 mg/L air

No. of animals per sex per dose:

12

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days - Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, pathology

Statistics:

Not specified

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

370 mg/L air

Based on:

test mat.

Exp. duration:

7 h

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks:

Effect levels were calculated using a vapour pressure of 10 Pa and rate of exposure of the substance in air per animal of 200 L of ‘air’/hour over 7 hours.

Mortality:

No mortality throughoout the study period

Clinical signs:

other: Slight mucosal irritation and rapid breathing.

Body weight:

Not reported

Gross pathology:

No relevant pathological findings in the organs.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study, the inhalation 7h-LC50 (male/female) was considered to be > 370 mg/L air.

Executive summary:

The study was performed according to Method according to Smyth et al. Am. Ind. Hyg. Ass. J. 23, 95-107, 1962   to assess the acute inhalation toxicity of the substance. The substance was filled in approx. 5 cm high a frit bottle made of glass, which was placed in a water bath at 20°C. The product flows through an air volume of 200 litres / hour. The vapor of the substance-enriched air stream was distributed to glass inhalation chambers. A single group of 12 Sprague-Dawley strain rats (males and females) were exposed to an air stream at 3, 10 and 30 minutes or 1, 3 and 7 hours and a follow-up period is 14 days.

The following investigations were conducted:

a) mortality

b) Poisoning symptoms

c) Section of those that have died and those after the follow-up time were killed with carbon dioxide

No mortality observed after 7 hours exposure and throughout the observation period. Slight mucosal irritation and rapid breathing were noted. No relevant pathological findings in the organs were observed.

Therefore, the LC50 was determined