Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1975
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:
1975
Report Date:
1975

Materials and methods

Principles of method if other than guideline:
Method: other: BASF-Test
GLP compliance:
no
Test type:
concentration x time method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Vat Blue 20

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: aerosol
Type of inhalation exposure:
not specified
Vehicle:
air
Remarks:
saturated with test item at 20°C
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:
not specified
Duration of exposure:
8 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: 14 days
- Frequency of observations: daily observation
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, necropsy
Statistics:
NA

Results and discussion

Preliminary study:
NA
Effect levels
Sex:
not specified
Dose descriptor:
LC0
Based on:
test mat.
Exp. duration:
8 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:
8 hours inhalation of a saturated athmosphere did not lead to any deaths in rats (0/12)