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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, heavy
EC Number:
930-690-7
Molecular formula:
Not applicable. A generic molecular formula cannot be assigned to this UVCB substance.
IUPAC Name:
Shale oils, heavy

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 145 - 160 g, females 120 - 140 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: To:

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, body weight, macroscopic evaluation
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:
Normal body weight gains were observed
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

140

1.4

0

165

25

185

20

2

120

1.2

0

140

20

155

15

3

135

1.35

0

155

20

180

25

4

Males

4

150

1.5

0

180

30

230

50

5

145

1.45

0

200

55

225

25

6

160

1.6

0

205

45

235

30

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, heavy is not toxic after single oral administration and belongs to class 5 (unclassified) according to GHS.
Executive summary:

Shale oils, heavy fraction was dosed orally via gavage to 3 female (120 - 140 g) and 3 male (145 - 160 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, heavy is not toxic after single oral administration and belongs to class 5 (unclassified) according to GHS.