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Toxicological information

Acute Toxicity: oral

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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 3, 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 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:
Linseed oil, oxidized
EC Number:
272-038-8
EC Name:
Linseed oil, oxidized
Cas Number:
68649-95-6
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 Linum usitatissimum, Linaceae (linseed)
Details on test material:
- Name of test material (as cited in study report): Boiled linseed oil (Leinöl-Firnis)
- Physical state: brownish-yellow, clear oil
- Storage condition of test material: normal room temperature, in darkness
- Other: 1 mL had an average weight of 0.9579 g (mean of 10 weighings).
No further data available

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Firma Charles River Wiga, Sandhofer Weg 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: 185.2 - 189.1 g
female: 150 - 167.7 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): 20 ± 2 ºC
- Humidity (%): 50 - 80%
- 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 15, 1988 To: March 3, 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 (for pre-test and for main test)
No. of animals per sex per dose:
Pre-test: 2 females
Main test: 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
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Remarks on result:
other: No mortalities
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 790 mg/kg bw
Based on:
test mat.
Remarks on result:
other: >5 mL/kg bw was equivalent to >4790 mg/kg bw
Mortality:
No mortalities
Clinical signs:
other: No clinical-toxicological symptoms observed
Gross pathology:
No macroscopic findings in the cranial-, thoracic- and abdominal cavity
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
based on Annex I of 1272/2008/EC (CLP)
Conclusions:
LD50 oral (rat): > 4790 mg/kg (>5 ml/kg)