Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Only 4 instead of 5 tested animals + unknown shaved area surface (cm2) + no mention of application under gauze + no detail on investigations (unknown whether any post-mortem examination done) + number of deaths not indicated = doubtful sensitivity and lack of details. The skin was abraded before treatment. However the moderate skin penetration (see 7.1) and the absence of acute oral toxicity imply an absence of dermal toxicity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Hazardous Substance Act
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Small Stock Industries, Pea Ridge, Arkansas
- Age at study initiation: young adults
- Weight at study initiation: 2.5 to 3.5 kg

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: not indicated
- % coverage: not indicated
- Type of wrap if used: rubber dam

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with lukewarm water
- Time after start of exposure: just after removal of the rubber dams

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 mL/kg
Duration of exposure:
24 hours
Doses:
5 mL/kg
No. of animals per sex per dose:
4 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not indicated
- Necropsy of survivors performed: not indicated
- Other examinations performed: clinical signs

Results and discussion

Preliminary study:
Not indicated
Effect levels
Sex:
not specified
Dose descriptor:
LDLo
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
Not indicated
Gross pathology:
Not indicated.

Applicant's summary and conclusion

Interpretation of results:
other: inconclusive
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The LDLo of the test substance after skin exposure during 24 hours is > 5 mL/kg. According to the volume mass of the test substance (0.96 kg/L), the LDLo of the test substance under the experimental conditions of the study is > 4.8 g/kg.