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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientific acceptable and well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Principles of method if other than guideline:
Ca. 200 l air per hour were conducted through ca. 100 ml of the test substance which was heated to 60°C. The air aerated in this way was applied to 5 male or 5 female rats. the animals were housed in a 10 l glass bottle and were exposed whole body to the test substance for 7 hours. Post-exposure period was 14 days.
GLP compliance:
yes
Test type:
other: inhalation hazard test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
content: 99.8%; density: 1.035 kg/liter (according LXS MSDS)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
male Wister rats, weight ca. 160 - 220 g, husbandry: standardised conditions, 5 animals per cage (makrolon type III)

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Animals were inspected several times on the same day of the application of the test substance. During the post observation period of 14 days animals were inspected twice daily and time of onset, duration, and severity of clinical signs recorded
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
7 h
Concentrations:
test substance was evaporated at 60°C
No. of animals per sex per dose:
5 male and 5 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: During the post observation period of 14 days animals were inspected twice daily and time of onset, duration, and severity of clinical signs recorded, animals were weighened before, after 1 week and at the end of the post-observation period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, pathology
Statistics:
not applicable - all animals survived

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
discriminating conc.
Effect level:
> 521 mg/m³ air (nominal)
Exp. duration:
7 h
Sex:
male
Dose descriptor:
discriminating conc.
Effect level:
> 671 mg/m³ air (nominal)
Exp. duration:
7 h
Mortality:
all animals survived
Clinical signs:
other: no signs of toxicity were observed
Body weight:
male rats, 671 mg/m³; animal 1: start 193 g ,end 212 g; animal 2: start 186 g ,end 202 g; animal 3: start 203 g ,end 232 g; animal 4: start 200 g ,end 226 g; animal 1: start 188 g ,end 203 g
fwmale rats, 521 mg/m³; animal 1: start 196 g ,end 194 g; animal 2: start 200 g ,end 201 g; animal 3: start 199 g ,end 198 g; animal 4: start 194 g ,end 185 g; animal 1: start 203 g ,end 205 g
Gross pathology:
no findings concerning organ injuries caused by the test substance
Other findings:
no data

Any other information on results incl. tables

No mortality and no signs of toxicity, delayed effects were not observable

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Executive summary:

Method: ca. 200 l air per hour were conducted through ca. 100 ml of the test substance which was heated to 60°C. the air aerated in this way was applied to 5 male or 5 female rats. the animals were housed in a 10 l glass bottle and were exposed hole body to the test substance for 7 hours. Post-exposure period was 14 days

Result: LC50 > 521 mg/m³ (rat, female); LC50 > 671 mg/m³ (rat, male), the whole body exposition for 7 hours of the saturated test atmosphere caused no mortality and no signs of toxicity were observable

Reference: Pauluhn (Bayer AG), 1984