Distillates (petroleum), hydrotreated middle

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1981-10-28 to 1982-08-04

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study report is classified as reliable without restrictions because it was conducted similar to OECD Test Guideline 402.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

A total of four animals were treated with abraded skin. OECD TG 402 does not suggest abraded skin being tested.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

64742-80-9

Cas Number:

64742-80-9

IUPAC Name:

64742-80-9

Constituent 2

Reference substance name:

Hydrodesulfurised middle distillate

IUPAC Name:

Hydrodesulfurised middle distillate

Test material form:

other: low viscosity liquid hydrocarbon

Details on test material:

- Name of test material (as cited in study report): API# 81-09 (CAS# 64742-80-9)
- Substance type: clear liquid
- Gravity API: 38.1
- Sulfur wt %:0.15
- Nitrogen ppm: <10
- Flash pt. °F: 255
- Boiling range (ASTM D-86) 10-95%: 519-562 °F
- Initial Boiling Point 502 °F
- End Boiling Point 574 °F
- Composition %:
paraffins 46.0
olefins 2.5
naphthenes 26.5
aromatics 25.0

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Dutchland Laboratories, Inc., Denver, Pennsylvania
- Age at study initiation: Young adults
- Weight at study initiation: Between 2609 grams and 2878 grams
- Fasting period before study: no
- Housing: Individual screen bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 14 days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 23 degrees Celsius
- Humidity (%): 28% to 58% relative humidity
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: Back of animal that has been shaved approximately 18 hours prior to treatment.
- % coverage: approximately 10%
- Type of wrap if used: Gauze bandage and overwrapped with Saran wrap and Elastoplast tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treated area was wiped clean but not washed.
- Time after start of exposure: 24 hours


VEHICLE - no vehicle was used.

Duration of exposure:

24 hours

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

Four males and four females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Rabbits were observed hourly for the first six hours after dosing, then daily for dermal irritation and twice daily for pharmacotoxic signs and mortality. Rabbits were weighed prior to treatment and again on day 7 and day 14.
- 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 mortality was observed during the study. All animals were euthanatized at study termination.

Clinical signs:

other: Three animals were reported to experience mild crusting, redness or both at the test site. Two male rabbits were reported to experience diarrhea after day one of the study. One male exhibited impaired use of the left hind leg on day 1 through day 14 of

Gross pathology:

No visible lesions were reported.

Other findings:

Three animals were reported to experience mild crusting, redness or both at the test site. Two male rabbits were reported to experience diarrhea after day one of the study. One male exhibited impaired use of the left hind leg on day 1 through day 14 of the study. It was not reported if these clinical effects were related to the treatment.

Body weight:
All animals were reported to gain weight between initial weigh-in and at 14 days.

Individual animal necropsy reports were not provided.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The dermal LD50 is >2000 mg/kg body weight.

Executive summary:

In an acute dermal toxicity study, 4 male and 4 female young adult New Zealand White rabbits were dermally exposed to hydrodesulfurised middle distillate for 24 hours to approximately 10% of the body surface, at a dose of 2000 mg/kg/body weight. The animals were observed for 14 days. Three animals out of eight that were treated with 2000 mg/kg body weight of test material were reported to experience mild crusting, redness or both at the test site. All animals gained weight throughout the study period. All animals survived and were terminated at the end of the study period. Gross necropsy results reported three animals experiencing mild crusting, redness or both at the test site. The diarrhea experienced by one animal and impaired use of the left hind leg of another was not considered to be an effect of the treatment.

The dermal LD50 was determined to be >2000 mg/kg body weight.

This study received a Klimisch score of 1 and is classified as reliable without restrictions because it was conducted similar to OECD Test Guideline 402.