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:
test procedure in accordance with national standard methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
BASF-Test
GLP compliance:
no
Test type:
other: BASF Method

Test material

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

Test animals

Species:
rat
Strain:
Wistar
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 vapour saturated at room temperature for 7 hours. To achieve saturation, 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, body weight, organ weights, histopathology
Statistics:
NA

Results and discussion

Preliminary study:
NA
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 mortaility
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
7 hours inhalation of a Palanilbrillantrosa REL 200% saturated atmosphere did not lead to any deaths in rats (0/12).
Executive summary:

In an acute inhalation toxicity study, 12 rats were exposed by inhalation route to the volatile constituents of the test material in a saturation concentration for 7 hours. Animals were then observed for 7 days.

No deaths occurred.