Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1963
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1963
Report Date:
1963

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
occlusive dressings used
Principles of method if other than guideline:
Method: other
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS

- Source: 'produced locally'

- Age at study initiation: 3 to 5 months

- Weight at study initiation: 2.5kg

- Diet: Rockland rabbit ration

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE

- Type of wrap if used: vinylite or polyethylene sheeting

Duration of exposure:
24 hours
Doses:
10 ml/kg
No. of animals per sex per dose:
4
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
None

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 10 mL/kg bw
Based on:
test mat.
Mortality:
No animals died (0/4).
Clinical signs:
Little skin irritation was observed but some desquamation was found after 14 days.
Body weight:
Two of the 4 animals lost weight (24 and 112 grams) during the 2 week observation period.
Gross pathology:
None reported.
Other findings:
None reported.

Any other information on results incl. tables

10 ml/kg is calculated to be 9500 mg/kg using the formula

ml/kg = mg/kg*density*1000, where density = 0.95

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 value of >10 ml/kg (>9500 mg/kg) for rabbits was reported in a reliable study conducted according to appropriate protocol. The study was not compliant with GLP.