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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:
08 - 24 Jun 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl linoleate
EC Number:
208-868-4
EC Name:
Ethyl linoleate
Cas Number:
544-35-4
Molecular formula:
C20H36O2
IUPAC Name:
ethyl octadeca-9,12-dienoate
Details on test material:
- Name of test material (as cited in study report): ethyl linoleate
- Physical state: hazy yellow liquid
- Purity: 75% ethyl linoleate
- Impurities: 11% Octadecenoic acid ethylester (Ethyl Oleate), 6% Hexadecanoic acid ethylester, 3% Octadecanoic acid ethylester, 3% Octadecadienoic acid glycerol monoester
- Storage: at room temperature in the dark
- Stability under storage conditions: stable
- Density: 0.88 g/mL

Test animals

Species:
rat
Strain:
other: Wistar strain Crl:WI (Han) (outbred, SPF-Quality)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: Body weight variation did not exceed +/- 20% of the sex mean.
- Fasting period before study: Animals were deprived of food overnight prior to dosing and until 3-4 hours after administration of the test substance
- Housing: 3 animals per cage in labelled Makrolon cages with sterilized sawdust as bedding material
- Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water: Free access to tap water.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 ± 3.0 (actual range: 19.8 - 21.5)
- Humidity (%): 40 - 70 (actual range: 3 8- 75)
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test substance was dosed as delivered by the sponsor. In order to obtain homogeneity, the test substance (formulations) were heated in a water bath with a maximum temperature of 41 ºC for a maximum of approximately 30 minutes. The test substance (formulations) were allowed to cool down to a temperature of maximally 40 ºC prior to dosing.


MAXIMUM DOSE VOLUME APPLIED: 2.27 mL/kg bw

The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. The first group was treated at a dose level of 2000 mg/kg. The absence or presence of mortality of animals dosed at one step determined the next step, based on the test procedure defined in the guidelines. The onset, duration and severity of the signs of toxicity were taken into account for determination of the time interval between the dose groups.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: At periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15. The symptoms were graded according to fixed scales and the time of onset, degree and duration were recorded.
- Frequency of weighing: days 1, 8, 15
- Necropsy of survivors performed: yes, descriptions of all internal macroscopic abnormalities were recorded.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
Hunched posture was observed for all animals on Day 1.
Body weight:
The body weight gain shown by the animals over the study period was considered to be normal.
Gross pathology:
No abnormalities were found at macroscopic post mortem examination of the animals.
Other findings:
The oral LD50 value in Wistar rats was found to exceed 2000 mg/kg body weight.
According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified