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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
The test material was applied to abraded skin.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Raw naphthenic acid derived from kerosene

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: The test material was applied to the abraded skin of the abdomen.
- Type of wrap if used: The area was covered with gauze and secured by a thick plastic binder.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The skin was washed with water or corn oil.
- Time after start of exposure: Following the removal of the dressing after the 24 hour exposure period.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.16 g/kg
Duration of exposure:
24 hours
Doses:
3.16 g/kg
No. of animals per sex per dose:
2 per sex
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rabbits were observed for mortality, toxicity and pharmacological effects 1, 2, 4 and 6 hours after dosing and once daily for 14 days. Bodyweights were recorded pre-test and in the survivors at 14 days. Dermal irritation was recorded at 24 hours, 3, 7, 10 and 14 days.
- Necropsy of survivors performed: Yes. At 14 days the survivors were sacrificed. Animals were examined for gross pathology.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 160 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, the LD50 was determined to be >3160 mg/kg and therefore the test material requires no classification in accordance with EU criteria.
Executive summary:

The potential of the test material to cause acute toxicological effects when administered via the dermal route was investigated in a study conducted broadly in accordance with the principles of the standardised guideline OECD 402.

The test material was applied at a limit dose of 3160 mg/kg to the abraded abdomen skin of two male and two female New Zealand White rabbits. The test site was covered with an occlusive dressing for 24 hours. The animals were observed for mortality, clinical signs and dermal irritation for 14 days.

Under the conditions of this study, the LD50 was determined to be >3160 mg/kg and therefore the test material requires no classification in accordance with EU criteria.