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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was carried out in a method similar to OECD TG 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:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
abraded areas also tested, this is not within the guidelines
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: semi-solid
Details on test material:
- Name of test material (as cited in study report): Vacuum Residuum API Sample 81-13, CAS No. 64741-56-6
- Substance type: Bitumen
- Physical state: Tar-like semi-solid
- Composition of test material,
weight percentage of components: Sample API 81-13: 4.46% sulphur, 0.51% nitrogen, 90+% carbon; 6.5% asphaltenes
<1 ppm copper, 33 ppm iron, 39 ppm vanadium, 18 ppm nickel
- Lot/batch No.: API 81-13
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: Stored at room temperature in original containers
- Other:Sample 81-13 was selected because of its high sulphur and asphaltene contents
- Distillation (ASTM D 11-60) °F- Initial Boiling Point 650
- Gravity API: 6.6

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratories, Inc., Denver, PA
- Weight at study initiation: 2.5 to 3.5 kilograms
- Housing: Maintained individually in 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): 20 to 23
- Humidity (%): 36 to 58
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 19-01-1982 To: 02-02-1982

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Remarks:
Material warmed overnight prior to application
Details on dermal exposure:
TEST SITE
- Area of exposure: Back
- % coverage: 10
- Type of wrap if used: Gauze bandage overwrapped with saran wrap and elastoplast tape
- 2 males and 2 females had test material applied to abraded areas.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Wiped clean, not washed
- Time after start of exposure: After 24 exposure

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
Duration of exposure:
24 hours
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
4 (2 intact, 2 abraded)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Hourly for the first 6 hours after dosing and twice daily, thereafter
- Necropsy of survivors performed: Yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
none
Clinical signs:
Mucoid diarrhea was exhibited by one female on day 1. Diarrhea was exhibited by one female on day 6 and 7.
Body weight:
Initial: 2752 grams (intact skin, male), 2809 grams (abraded skin, male), 2778 grams (intact skin, female), 2847 grams (abraded skin, female)
7 days: 2828 grams (intact skin, male), 2831 grams (abraded skin, male), 2660 grams (intact skin, female), 2559 grams (abraded skin, female)
14 days: 3138 grams (intact skin, male), 3218 grams (abraded skin, male), 2982 grams (intact skin, female), 2835 grams (abraded skin, female)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information LD50 >2000 mg/kg body weight; not classified under EU CLP (EC 1272/2008) Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 was found to be greater than 2000 mg/kg body weight in male and female rabbits.
Executive summary:

In an acute dermal toxicity study, groups of New Zealand White Rabbits (4/sex) were dermally exposed to Vacuum Residuum (petroleum) for 24 hours to 10% of body area at a single dose of 2000 mg/kg body weight. Skin was abraded in 2 male and 2 female animals before application. Animals then were observed for 14 days.

 

There were minimal treatment related clinical signs and no significant treatment related necropsy findings or changes in body weight. The dermal LD50 was determined to be greater than 2000 mg/kg body weight in in males and females.

 

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was carried out in a method similar to OECD TG 402.