Benzene, C20-24 (even numbered) sec-alkyl derivs.

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: GLP study by OECD methods.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

LAB

IUPAC Name:

LAB

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hacking and Churchill Limited
- Age at study initiation: 6-8 weeks
- Weight at study initiation: 206-250 g
- Housing: individually in metal cages, identified by cage number and ear punching
- Diet (e.g. ad libitum): Spratt's Rodent Breeding Diet (LAD 1), ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 10
- Type of wrap if used: gauze held in place with impermeable dressing over the trunk


REMOVAL OF TEST SUBSTANCE
- Washing (if done): 30-40 degree C water
- Time after start of exposure: 24 hrs


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg bw

Duration of exposure:

24 hrs

Doses:

2.0 g/kg bw

No. of animals per sex per dose:

5 male and 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations - twice daily for mortality and signs of toxicity, daily for skin observations, bodyweights were taken on days 1, 8, and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

No animals died during the study.

Clinical signs:

other: Nine of the animals developed a slightly raised red area at the dose site on day 6. Scabs formed at this area by day 9. All animals were fully recovered by the end of the experiment.

Gross pathology:

No abnormalities were noted at autopsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of LAB was greater than 2000 mg/kg.

Executive summary:

This study determined the acute dermal toxicity of the test substance in rats. 5 male and 5 female rats were exposed to 2000 mg/kg bw of test substance dermally. Exposure lasted 24 hrs, after which the test substance was removed by washing. The animals were observed for the next 14 days for clinical signs and mortality. All animals were necropsied at the end of the experiment. No animals died during the study. The dermal LD50 in rats is > 2000 mg/kg bw. The test substance is not classified as a dermal toxicant under EU GHS guidelines.