1,4-dioxane

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

05 May - 10 June 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Principles of method if other than guideline:

Inhalation Risktest as in Annex 1 of OECD 403; method based on the publication by Smyth HF et. al. (1962). Am. Ind. Hyg. Ass. J. 23: 95-107.

GLP compliance:

no

Test type:

other: inhalation risk test

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,4-dioxane

EC Number:

204-661-8

EC Name:

1,4-dioxane

Cas Number:

123-91-1

Molecular formula:

C4H8O2

IUPAC Name:

1,4-dioxane

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Fa . Wiga Versuchstieranstalt, Sulzfeld
- Strain: Caw-Ico-Wiga (SPF)
- Age at study initiation: 7 - 10 weeks
- Weight at study initiation: males: 180 - 250 g; females: 180 - 250 g
- Housing: 3 animals/cage
- Diet (ad libitum): Herilan MRH as pellets (EGGERSMANN KG, Rinteln)
- Water (ad libitum): dailyapprox. 250 mL tap water/cage
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 50 + 5 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
The product was filled in a column of about 5 cm above a fritted glass disc in a glass cylinder (diameter 30 mm) placed in a water bath at 20 ± 1 °C. Fresh air was bubbled at a rate of 200 L/h through the substance column generating a highly saturated substance-vapour-mixture which was led through six glass tubes containing 3 male and female test animals. Exhaust air was disposed of. In case of exposure periods above 30 min, the substance column was replaced after 30 min by a newly filled column. This column was then used for the remaining exposure period. In case the substance in the glass column was spent well before the end of the first 30 min, the substance column was refilled as often as needed to ensure a constant substance-vapour-mixture at least within the first 30 min. The amount of test substance used in the system was determined at the end of the exposure period by weighing.

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

7 h

Concentrations:

mean: 155 mg/L (corresponding to 43 000 ppm)

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Body weights were determined only at test start.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross-pathological examination

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC0

Effect level:

ca. 155 mg/L air (nominal)

Exp. duration:

1 h

Mortality:

1 h exposure: 0/12
3 h exposure: 6/12
7 h exposure: 4/18

Clinical signs:

other: Vigorous flight attempts, dyspnoea, red eye discharge, eye lids adhering, crust formation on nose, complete closure of the eye lids, snout wiping, loss of the lid reflex, narcosis, apathy, squatting posture, ruffled fur, staggering, halting, high stepping

Body weight:

no data

Gross pathology:

Deceased animals:
- Heart: acute dilatation
- Stomach: multiple, hemorrhagic erosions, bloody stomach contents
- Lungs: acute pulmonary emphysema
- Intestines: bloody faeces in some sections, atonic, diarrheic contents

Sacrificed animals:
- without findings

Any other information on results incl. tables

Mortality:

Exposure time [h]	1	3	7
No. of dead / no. of treated animals	0/12	6/12	4/18

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met