Shale oils, heavy

Acute Toxicity: oral

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

Test material information

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:

other: None 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.