Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
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:
1976
Report Date:
1976

Materials and methods

Principles of method if other than guideline:
BASF Test: saturated atmosphere at 20°C
GLP compliance:
no
Test type:
concentration x time method
Limit test:
yes

Test material

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

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
not specified
Vehicle:
not specified
Remarks:
vapour
Details on inhalation exposure:
Inhalation by means of vapour saturated at 20°C for 8 hours. To achieve saturation, air was fed through an approx. 5 cm deep layer of the product.
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Remarks on duration:
also determined: 3, 10, 30 min and 1, 3 h
No. of animals per sex per dose:
12
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

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LC50
Exp. duration:
8 h
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No mortality observed.
Clinical signs:
No signs of toxic effect observed.
Gross pathology:
Organs without any findings.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In an inhalation risk test performed with 12 rats, no mortality or other toxic effects occured after 8 h exposure to a saturated atmosphere and during the post exposure period of 7 d.