Registration Dossier

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 study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1961
Report Date:
1961

Materials and methods

Principles of method if other than guideline:
BASF-Test: Test was performed in principle as described in OECD Guideline 403.
The test demonstrates the toxicity of an atmosphere saturated with vapours of the volatile components of a test substance at the temperature chosen for vapour generation (room temperature). 3 rats per sex were exposed sequentially to the vapours, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 8 h. The documentation of clinical signs was performed over a period of 7 days.
GLP compliance:
no
Test type:
other: BASF Inhalation Test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Physical state: solid
Degree of Purity: no data

Test animals

Species:
rat
Strain:
other: Hannover
Sex:
male/female
Details on test animals and environmental conditions:
Mean body weight at test initiation: ca. 152 g

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
other: unchanged (no vehicle)
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
saturated vapour
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
other: IRT (Inhalation Risk Test)
Exp. duration:
8 h
Remarks on result:
other: mortality 0/6 animals
Sex:
male/female
Dose descriptor:
LC0
Effect level:
0.061 mg/L air (nominal)
Based on:
test mat.
Exp. duration:
8 h
Mortality:
All animals survived.
Clinical signs:
other: An intermittent agitation of the animals was noticed shortly after treatment initiation.
Body weight:
The mean body weight was ca. 152 g at test initiation, and ca. 166 g at the end of the observation period.
Gross pathology:
No treatment related changes observed.

Any other information on results incl. tables

The inhalation of a enriched/saturated vapor-air-mixture caused no mortality within 8 h.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
nontoxic if inhaled
Executive summary:

The sudy was performed according a standard inhalation hazard BASF Test. The principles of the performing of this test is similar with the requirements of the OECD guideline 403.

A saturated test atmosphere of test material was generated. At this conditions 0/6 rats died after 8 h exposure (BASF AG 1961). Intermittent agitation directly after treatment ignition was the only clinical sign observed; there were no necropsy findings in the survivors after 7 d observation period.

No LC50 value could be established because no mortalities were occured during the test. LC0 is 0.061 mg/L (saturated atmosphere)