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Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well performed study according to acknowledged rule

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: company SOP
Principles of method if other than guideline:
The animals were exposed to an air / substance - mixture
GLP compliance:
no
Test type:
other: Zeitsättigungstest

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: males: 181 - 190 g; females: 180 - 189 g
- Housing: plastic cages
-During observation period: Diet: Altromin 1324, ad libitum
- During observation period: Water: Tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.4 - 25.9
- Humidity (%): 10 - 39.4

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
120 g of the test substance was filled in a gas-washing-bottle. An air stream of 600 L / hours was blown through this gas washing-bottle into the exposure-cylinder. The pipes leading from the gas washing-bottle into the exposure cylinder were constructed in that way, that only the noses of the animals were inside this cyclinder
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Concentrations:
2.06 g of the test item were blown into the exposure cylinder during 7 hours
No. of animals per sex per dose:
6 males and 6 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: daily and weighing: once a week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Mortality:
no
Clinical signs:
no
Body weight:
normal development
Gross pathology:
no findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No symptoms of inhalative toxicity observed
Executive summary:

6 male and 6 female Wister rats were exposed during 7 hours to an air / substance mixture containing 2.06 g of the test item in the so called "Zeitsättigungstest". No mortality occured and no clinical signs were observed in the 14 days observation period and the development of the body weight was normal..