Rape oil, oxidized

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

February 15, 1988 - March 2, 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Not GLP, but well described and in accordance with OECD 401.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Rape oil, oxidized

EC Number:

305-871-3

EC Name:

Rape oil, oxidized

Cas Number:

95193-59-2

Molecular formula:

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

IUPAC Name:

Oxidation products of seed oil obtained from Brassica napus, Brassicaceae (rapeseed)

Details on test material:

- Name of test material (as cited in study report): Blown rapeseed oil, 60 P. (Geblasenes Rüböl, 60 P.)
- Molecular formula (if other than submission substance): no data
- Molecular weight (if other than submission substance): no data
- Smiles notation (if other than submission substance): no data
- InChl (if other than submission substance): no data
- Structural formula attached as image file (if other than submission substance): no data
- Substance type: no data
- Physical state: yellow-brownish, clear, strong viscous liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: normal room temperature, in darkness
- Other: 1 mL had an average weight of 0.997 g (mean of 10 weighings).

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wega, Sandhoferweg 7, 8714 Sulzfeld, Germany
- Age at study initiation: no data, but based on the animal weight at study start the animals were young adults.
- Weight at study initiation: male 182-188.8 g; females 160-164.3 g
- Fasting period before study: from 16 hours before treatment until 4 hours after treatment
- Housing:collective caging, Macrolon type III cages, with bedding.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22°C
- Humidity (%): 50-80% rH
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hours dark and 12 hours light, fluorescent light, 120 lux

IN-LIFE DATES: From: February 15th 1988 To: March 2nd, 1988

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE; none (administered as received)

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

DOSAGE PREPARATION (if unusual): administered as received

CLASS METHOD (if applicable): not relevant

Doses:

5 mL/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality and symptoms about 20 min, 1 h, 2 h, 3 h, 6 h after treatment and once daily thereafter until day 14; weighing on day 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: no

Statistics:

not relevant

Results and discussion

Preliminary study:

two female rats were administered 5 mL/kg bw; no mortality occurred.

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 985 mg/kg bw

Based on:

test mat.

Remarks on result:

other: >5 mL/kg bw was equivalent to >4985 mg/kg bw

Mortality:

none

Clinical signs:

other: none were observed

Gross pathology:

no macroscopic findings in teh cranial, thoracic and abdominal cavity

Other findings:

no other findings

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Acute oral LD50 of blow rapeseed oil 60 P >5 mL/kg bw (>4985 mg/kg bw).