Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

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:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- 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 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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LC50
Effect level:
124.7 mg/L air
Exp. duration:
4 h
Sex:
male
Dose descriptor:
LC50
Effect level:
116.9 mg/L air
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC50
Effect level:
133.8 mg/L air
Exp. duration:
4 h
Mortality:
see free text
Clinical signs:
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 symptoms after day 1 till the end of observation period.
In the lowest dose group: attempts to escape, reddish-watery eyes, nasal secretions, closing of eyelids, snout wiping, intermittent respiration, loss of pain reflex, abdominal position and apathy. All animals were free from symptoms after day 1 till the end of observation period.
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).