Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
end on 26-APR-2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test performed according to OECD/EU testing guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triglycerides, C12-24, saturated ans unsaturated, oxidized
- Substance type: UVCB
- Physical state: liquid
- Stability under test conditions: data not available
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: from the copany Charles River Deutschland GmbH, D-97633, Sulzfeld
- Age at study initiation: data not available
- Weight at study initiation: between 153g and 163g
- Fasting period before study: yes
- Housing: the rats were kept in transparent macrolone cages (type 3-180, floor area 810 cm2) with 3 in each cage. the cages were cleaned and the bedding changed at least twice a week.
- Diet: free access to a pelleted diet "Altromin 1324"
- Water: free access to bottles of drink water of domestic quality, which was acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 3°C
- Humidity: at least 30% and preferably not exceed 70%
- Air changes: 10 times/hour
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From 02-NOV-2009 to 24-NOV-2009

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: data not available
- Amount of vehicle (if gavage): 10 ml/kg bw
- Justification for choice of vehicle: data not available

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: data not available
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2 x 3 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> each rat was observed 30 minutes, 2 hrs, 4hrs and 6hrs after the administration and therafter daily for a period of 14 consecutive days
> the body weight was determined on days 0, 7 and 14
- Necropsy of survivors performed: yes
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed at this dose
Mortality:
All six animas survived the treatment with the test item.
Clinical signs:
In group 1, a hunched posture and piloerection were observed in animals No. 1, No. 2 and No. 3 on the day of application after 30 minutes. After 2hrs, 4hrs and 6hrs the three rats showed piloerection. Piloerection was also observed in animal No. 1 on day 1, whereas animals No. 2 and No. 3 showed normal behaviour. From day 2 to the end of the observation period, all three animals were free of any abnormalities.

In group 2, a hunched posture and piloerection were observed in animals No. 4, No. 5 and No. 6 on the day of application after 30 minutes and 2hrs. After 4hrs all three animals still showed piloerection as well as after 6hrs animals No. 4 and No. 6 only. Normal behaviour was observed in animal No. 5 after 6 hrs. From day 1 to the end of the observation period all three animals were free of any abnormalities.
Body weight:
The body weight increased in each animal indicating a physiological development.
Gross pathology:
in the autopsy, no pathological sign was detected

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
oral LD50 (rat, females) > 2000 mg/kg bw
Executive summary:

In an acute oral toxicity study (OECD 423, GLP), groups of fasted, Wistar rats (2 x 3 females) were given a single oral dose of Triglycerides, C12-24, even, saturated and unsaturated, oxidized (100% purity) in olive oil at the dose of 2000 mg/kg bw and observed for 14 days.

 

Oral LD50 (females) > 2000 mg/kg bw

 

No mortality, no effect on body weight and no macroscopic abnormalities were observed.

Few clinical signs were observed: hunched exposure (30min to 2hrs after application) and piloerection (day 1 and 2).

 

The study is considered as valid. According to this result, Triglycerides, C12-24, even, saturated and unsaturated, oxidized is not classified according to EU criteria (directive 67/548/EEC and CLP).