Shale oils

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8th April - 12th August 2005

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Shale oils

EC Number:

269-646-0

EC Name:

Shale oils

Cas Number:

68308-34-9

Molecular formula:

Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)

IUPAC Name:

Shale oil

Constituent 2

Reference substance name:

Shale Oils

IUPAC Name:

Shale Oils

Details on test material:

Identification: Shale oil, middle fraction
Description :Liquid
Batch number: 1
Purity min.: 99 %
Density: 980 kg/m^3
Composition: Complex mixture of hydrocarbons and oxygen compounds
Stability of test item: Stable under storage conditions
Expiry date: 04-MAR-2006
Storage conditions: At room temperature (range of 20 ± 5 °C), light protected.
Safety precautions: Routine hygienic procedures were used to ensure the health and safety of the personnel.

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services CH-4414 Füllinsdorf / Switzerland
- Age at study initiation: Males: 8 weeks. Female: 12 weeks
- Weight at study initiation: NDA
- Fasting period before study: NDA
- Housing: During acclimatization in groups of five per sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding during treatment and observation.
- Diet (e.g. ad libitum): Pelleted standard provided ad libitum
- Water (e.g. ad libitum): Community tap water from Füllinsdorf ad libitum.
- Acclimation period: 8th - 12th April 2005

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 5
- Humidity: 30 - 70 %
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark with music played during the daytime period

IN-LIFE DATES: From: 8th April 2005 To: 27th April 2005

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: NDA
- % coverage: 10 %
- Type of wrap if used: The dressing was wrapped around the abdomen and fixed with an elastic adhesive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin flushed with luke warm water
- Time after start of exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.04 mL/kg bw
- Concentration (if solution): N/A
- Constant volume or concentration used: yes
- For solids, paste formed: N/A

VEHICLE
N/A

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 per sex per dose

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: on days 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, local signs

Statistics:

No statistical analysis used.

Results and discussion

Preliminary study:

not applicable.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: No systemic signs of toxicity were observed during the course of the study. Due to brown discoloration of the application site in all animals, local symptoms could not be assessed on test day 2. Slight general erythema was observed in six animals at the r

Gross pathology:

No macroscopic findings were observed at necropsy.

Other findings:

NDA

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to EU criteria

Conclusions:

The median lethal dose of Shale oil after single dermal administration to rats of both sexes, observed over a period of 14 days is:
LD50 (rat): greater than 2000 mg/kg body weight.

Executive summary:

Five male and five female HanRcc:WIST (SPF) rats were treated with Shale oil at 2000 mg/kg by dermal application in accordance with OECD 402 and to GLP standard. The test item was applied undiluted as delivered from the sponsor at a volume dosage of 2.04 mL/kg. The application period was 24 hours.

No mortality, clinical signs or abnormal body weight changes were observed. Mild to moderate skin irritation effects were observed in all animals.

The median lethal dose of Shale oil after single dermal administration to rats of both sexes, observed over a period of 14 days is:

LD50 (rat): greater than 2000 mg/kg body weight.