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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Restriction due to the fact that this is a summary report. Only 2 dose levels used.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
Method: other: Similar to OECD 402 and FHSA 16CFR 1500.4
GLP compliance:
no
Remarks:
Pre-dates GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Phenol, (tetrapropenyl) derivatives (CAS No. 74499-35-7). Test material dosed as received, purity not provided.
Dark amber viscous liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
Rabbits used were male New Zealand Whites. They were housed in wire bottom cages, and were allowed free access to Purina Rabbit Chow and water at all times.

All animals were kept in an air-conditioned room, and the temperature was maintained between 68 and 72°F.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Six rabbits per dose level were clipped and wrapped with an impervious plastic sheet. The test material was applied under the sheet at doses of 15 g/kg or 5 g/kg. Twenty-four hours later, the wraps were removed. The animals were observed for 14 days, and survivors were sacrificed at that time.
Duration of exposure:
24 hours
Doses:
5000 and 15,000 mg/kg
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: The heart, thymus, lungs, liver, pancreas, spleen, kidneys, adrenals, gastro-intestinal tract, body fat, gonads and skeletal muscle were examined carefully for gross pathology.
Statistics:
No data

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 15 000 mg/kg bw
Based on:
test mat.
Mortality:
DOSE MORTALITY

15 g/kg 3/6
5 g/kg 0/6
Clinical signs:
Death occurred within seven days and was preceded by depression, anorexia and very violent terminal clonic convulsions.
Body weight:
No data
Gross pathology:
Autopsies done on animals dying revealed pale edematous kidneys. Autopsies done on one of the survivors at 15 g/kg 14 days after dosing, showed similar changes in the kidneys. The remaining two were normal. Autopsies done at 14 days on the 5 g/kg rabbits showed no grossly abnormal anatomy.
Other findings:
Almost all of the dose at 15 g/kg and all at 5 g/kg was absorbed. The skin appeared soft, and very swollen at 24 hours in both groups. By 96 hours, the skin was hard, cracking and very red, indicating destruction of the skin.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material, when administered to rabbits, had an acute dermal LD50 of approximately 15,000 mg/kg. Dermal irritation was evident in all animals.
Executive summary:

Three of six rabbits dosed at 15 grams per kilogram died within seven days. None of six animals dosed at 5 grams per kilogram died within a 14-day observation period. There was no incidence of gross pathology in survivors sacrificed 14 days after dosing.

The test material, when administered to rabbits, had an acute dermal LD50 of approximately 15,000 mg/kg. Dermal irritation was evident in all animals.