Registration Dossier

Toxicological information

Acute Toxicity: inhalation

Currently viewing:

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
27. Mar 1990 - 10. Apr 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
(adopted 1981)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
adopted 2009
Deviations:
yes
Remarks:
(limit concentration for vapours of 20 mg/L not tested)
GLP compliance:
no
Test type:
fixed concentration procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: male: 255 ± 7 g, female: 183 ± 7 g
- Housing: groups of five per cage
- Diet: KLIBA rat/mouse laboratory diet ad libitum
- Water: ad libitum



ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- 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)
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gas chromatography
Duration of exposure:
4 h
Concentrations:
4.31 mg/L
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing: before the beginning of the test, after 7 days and at the end of the observation period.
- Frequency of observations: several times during exposure and at least once on each workday in the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights
Statistics:
The statistical evaluation of the concentration/effect relationship was carried out on the basis of the binomial test in accordance with tables of the BASF Computer Center.

Results and discussion

Effect levelsopen allclose all
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 4.31 mg/L air
Exp. duration:
4 h
Remarks on result:
other: no mortality occured
Key result
Sex:
male/female
Dose descriptor:
LC0
Effect level:
4.31 mg/L air
Exp. duration:
4 h
Remarks on result:
other: no mortality occured
Mortality:
No mortality occured.
Clinical signs:
During exposure: animals showed immediately escape attempts, eyelid closure, accelerated respiration and after 15 min restlessness. After 2 h irregular respiration and closed eyelids were noted.

After exposure and during observation period: up to 24 accelerated respiration and ruffled fur. After 48 h males showed aggressiveness and therefor were single housed. After 3 days all animals were considered as normal.
Body weight:
The body weight gain of the male rats in the test group, compared with a historical. control collective, was not affected by the substance over the total observation period.
The body weight gain of the female rats in the test group, compared with a historical control collective, was slightly retarded in the second week of the observation period.
Gross pathology:
No pathologic findings noted.

Any other information on results incl. tables

Body weight:

 Mean body weight (in g)   male        female     
 day 0  day 7  day 14  day 0  day 7  day 14
Test group  255  280  319  183  195  207
 Historical control group  248  286  318  177  196  211

The animals exhibited distinct eye irritation at the day of exposure which repressed during the recovery period (corneal stipplings, fundus not visible). There is indication that the test substance causes local irritation to exposed tissues, including respiratory tract.

Although the limit concentration of 5 mg/L was not fully met, the test is judged sufficient to characterize the acute inhalation toxicity of the substance as virtually nontoxic.

Applicant's summary and conclusion