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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

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:
Rape oil, oxidized
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 levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
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:
none were observed
Body weight:
body weight development was nomal
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).