Ethanol

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethanol

EC Number:

200-578-6

EC Name:

Ethanol

Cas Number:

64-17-5

Molecular formula:

C2H6O

IUPAC Name:

ethanol

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Ethanol rein
- Physical state: clear liquid
- Analytical purity: 99.8%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: WIGA, Sulzfeld
- Mean weight at study initiation: 185 ± 15 g
- Diet (e.g. ad libitum): Herilan MRH
- Water (e.g. ad libitum): Tap water


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

inhalation: vapour

Type of inhalation exposure:

nose/head only

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- The test substance was heated up to 65 °C, the vapors generated were mixed with a stream of fresh air and delived to the inhalation-system in constant amounts with the help of a dosing pump.


TEST ATMOSPHERE
- Brief description of analytical method used: Gas-chromatography
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:

yes

Remarks:

Gas-chromatography

Duration of exposure:

4 h

Concentrations:

155.0, 115.4, 93.4, 79.1, 62.0 mg/l

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs were observed daily, body weight were measured at the begining of the study and weekly thereafter
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Probitanalysis as described in DJ Finney (Probitanalysis 1971, 1 - 150).

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LC50

Effect level:

124.7 mg/L air

Exp. duration:

4 h

Effect levels 2

Sex:

male

Dose descriptor:

LC50

Effect level:

116.9 mg/L air

Exp. duration:

4 h

Effect levels 3

Sex:

female

Dose descriptor:

LC50

Effect level:

133.8 mg/L air

Exp. duration:

4 h

Mortality:

see free text

Clinical signs:

other: In the top 4 dose groups: attempts to escape, reddish-watery eyes, nasal secretions, closing of eyelids, snout wiping, intermittent respiration, loss of pain reflex, narcosis, ruffled fur-coat and squatting position. The surviving animals were free from s

Body weight:

The body weight of males in higher dose groups was slightly decreased.

Gross pathology:

Deceased animals: acute dilation and hyperemia in heart. Lungs showed partly acute flatulence of middle grade. Additionally, lungs were partly spotted, infracted, blood-filled and edematous.
Sacrificed animals: no abnormalities

Any other information on results incl. tables

Concentration (mg/L)	Mortality
	male	female
155.0	7/10	9/10
115.4	7/10	1/10
93.4	2/10	0/10
79.1	1/10	0/10
62.0	0/10	0/10

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on the results, the test substance do not require any classification according to EU and GHS standards.

Executive summary:

In an acute inhalation study that approximated to guideline, ethanol vapour was found to be of very low acute toxicity to male and female rats. The LC50 (4hr) was established to be around the 117 -125mg/l and the LC0 around 62mg/l. It is worthy of note that the LD50 is well above the lower explosive limit (LEL).