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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
5th March - 14th April 2010
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:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Reference substance name:
Shale oils, light
EC Number:
923-592-0
Molecular formula:
Not applicable. A generic molecular formula cannot be assigned to this UVCB substance.
IUPAC Name:
Shale oils, light

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Accredited Breeding Velaz, Prague, Czech Republic
- Age at study initiation: NDA
- Weight at study initiation: Males 175 - 190 g, females 150 - 155 g
- Fasting period before study: overnight prior to study
- Housing: Animals were housed 3 to a cage with wooden grate bedding and in conformity with animal welfare legislation.
- Diet (e.g. ad libitum): A standard certified laboratory diet was served. The diet is routinely analysed by the manufacturer for nutritional components and environmental contaminants.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 ºC
- Humidity (%): 55 ± 10 %
- Air changes (per hr): 10 per hour
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

IN-LIFE DATES: From: 18th March 2010 To: 7th April 2010

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: NDA
- Lot/batch no. (if required): L 812160
- Purity: NDA

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

DOSAGE PREPARATION (if unusual): Test article was mixed with vehicle shortly before administration. Required amount of test article was weighed out and mixed with precise amount of vehicle shortly before application.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (3 male/3 female) animals per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 7 and 14 days after application
- Necropsy of survivors performed: yes
- Other examinations performed:
- Clinical signs:
Animals were observed individually after dosing at least once during the first 30 minutes, periodically during the first 24 hours, with special attention given during the first 4 hours and daily thereafter, for a total of 14 days. Duration of observation was considered sufficient. All observations are systemically recorded. Clinical signs and conditions associated with pain, suffering and impending death, are described in detail in a separate OECD Guidance Document. Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems, and somatomotor qactivity and behaviour pattern. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy sleep and coma.

- Body weight:
Individual weights of animals were determined shortly before the test article was administered and weekly thereafter. Weights of animals were recorded at the end of the study. Weight changes after first and second weeks after application were calculated and recorded.

- Pathology:
After finishing of observation period, the animals were sacrificed by exsanguinations in ether narcoses. The necropsies were made by standard operation procedures. All tested animals were subjected to a full, detailed gross necropsy, which included carful examination of external surface of the body, all orifices, and cranial, thoracic and abdominal cavities and their contents. All gross pathological changes will be recorded for each animal.
Statistics:
NDA

Results and discussion

Preliminary study:
NDA
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None observed
Clinical signs:
None observed
Body weight:
Smaller than expected body weight gains in males and a 5g body weight loss in one female were recorded 1 week after administration. Anticipated body weights were observed during the second week after adminstration.
Gross pathology:
One male had an enlarged spleen with an uneven surface. One female was found with an uneven surface on the spleen. No other effect were found.
Other findings:
NDA.

Any other information on results incl. tables

Table 1: Body weight changes

Cage

No.

Sex

Animal

No.

B.W.

initial

[g]

Applied

volume

[ml]

Response

 

    After 1 week

    After 2 weeks

B.W.

[g]

B.W. change

[g]

B.W.

[g]

B.W. change

[g]

3

Females

1

150

1.50

0

150

0

170

20

2

155

1.55

0

150

-5

155

5

3

155

1.55

0

170

15

185

15

4

Males

4

175

1.75

0

180

5

225

45

5

180

1.80

0

200

20

250

50

6

190

1.90

0

210

20

255

45

Response: 0 - surviving

X - death

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 to male and female rats was > 2000 mg/kg bw, It can be concluded that product Shale oils, light is not toxic after single oral administration and is therefore not classified according to the EU CLP criteria.
Executive summary:

Shale oils, light fraction was dosed orally via gavage to 3 female (150 - 155 g) and 3 male (175 - 190 g) wistar rats at limit dose of 2000 mg/kg, in accordance with OECD 423 and performed to GLP. Neither death nor visible symptoms of toxicity during 14 day observation period were seen. It can be concluded that product Shale oils, light is not toxic after single oral administration and is therefore not classified according to the EU CLP criteria.

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