Glycerides, C10-20 and C10-20-unsatd., oxidized

Acute Toxicity: oral

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

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

Test material information

Constituent 1

Reference substance name:

Oils, fish, oxidized

EC Number:

269-122-1

EC Name:

Oils, fish, oxidized

Cas Number:

68187-75-7

IUPAC Name:

68187-75-7

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 or test system 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:

other: 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

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).