Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1965
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:
1965
Report Date:
1965

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
7 day post-observation, reporting details
GLP compliance:
no
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
other: albino rabbit, no further data
Sex:
male
Details on test animals and environmental conditions:
no data

Administration / exposure

Type of coverage:
other: occlusive or semicclusive
Vehicle:
water
Details on dermal exposure:
aqueous paste, held in continous contact with shaved rabbit skin.
Duration of exposure:
24h
Doses:
10000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Frequency of observations and weighing: observations day 1 - 7
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other:
Statistics:
not required

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Mortality:
none
Clinical signs:
No clinical signs observed.
Body weight:
average weight at the start: 3.00 kg
average weight at the end: 3.03 kg
Gross pathology:
No adverse findings observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met