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Diss Factsheets

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
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

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.