Registration Dossier

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
Study period:
1978-02-13 to 1979-11-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
BASF-Test; based on: H.F. Smyth et al., 1963. Am. Ind. Hyg. Ass. J.23, 95-107.
GLP compliance:
no
Test type:
other: BASF method

Test material

Reference
Name:
Unnamed
Test material form:
solid

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Details on inhalation exposure:
Inhalation by means of vapor saturated at 20 °C for 7 hours. To achieve saturation, 200 L air/h air was fed through an approx. 5 cm deep layer of the product.
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
7 h
Concentrations:
saturation concentration
No. of animals per sex per dose:
12 rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: daily observation, weekly weighing
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology
Statistics:
n.a.

Results and discussion

Preliminary study:
n.a.
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LC0
Based on:
test mat.
Exp. duration:
7 h
Remarks on result:
other: no effect at saturation concentration
Mortality:
No deaths
Clinical signs:
No effects
Body weight:
No data
Gross pathology:
No effects

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
7 hours inhalation of an saturated atmosphere did not lead to any deaths in rats (0/12).
Executive summary:

In an acute inhalation toxicity study, rats were exposed by inhalation to the test item in a saturated atmosphere for 7 hours. Animals then were observed for 7 days. No deaths and no gross pathological signs of toxicity were observed.