Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1975
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute 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

Type of coverage:
not specified
Vehicle:
water
Remarks:
to form a paste
Details on dermal exposure:
50% aqueous paste
Duration of exposure:
24 hours
Doses:
2500 mg/kg bw
No. of animals per sex per dose:
no data
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: clinical signs daily
- Necropsy of survivors performed: yes
Statistics:
NA

Results and discussion

Preliminary study:
NA
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 500 mg/kg bw
Based on:
test mat.
Mortality:
no deaths
Clinical signs:
no effect
Body weight:
no data
Gross pathology:
no effect

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
acute dermal LD50 in rats is higher than 2500 mg/kg bw