Naphthenic acids, potassium salts

Acute Toxicity: dermal

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

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

Test material information

Constituent 1

Reference substance name:

Naphthenic acid

IUPAC Name:

Naphthenic acid

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.