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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:
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

Constituent 1
Reference substance name:
Hydrodesulfurised middle distillate (CAS# 64742-80-9)
IUPAC Name:
Hydrodesulfurised middle distillate (CAS# 64742-80-9)
Details on test material:
- Name of test material (as cited in study report): API 81-9 (CAS# 64742-80-9)
- Physical state: Clear liquid

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: atleast 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 hours 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 animals were reported dead due to treatment. All animals were euthanatized at study termination.
Clinical signs:
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.
Gross pathology:
No visible lesions were reported.
Other findings:
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 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 2.0 g/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.