Corn oil (Zea mays, Gramineae), peroxidised

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 04 February 2011 to 01 April 2011

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was performed in accordance with OECD guideline and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

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:

no

Test material

Test material information

Constituent 1

Reference substance name:

corn oil, peroxidised

IUPAC Name:

corn oil, peroxidised

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland GmbH, D-97633 Sulzfeld
- Age at study initiation: no data
- Weight at study initiation: between 150 and 174 g
- Fasting period before study: fasted overnight prior to dosing
- Housing: transparent macrolone cages (floor area 810 cm²), three animals per cage
- Diet: free access to a pelleted diet "Altromin 1324"
- Water (e.g. ad libitum): free access to bottles with domestic quality drinking water , 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: ± 3°C
- Humidity (%): at least 30% and preferably not exceeding 70%
- Air changes: 10 times/hour
- Photoperiod: 12hrs dark / 12hrs light

IN-LIFE DATES: from 18 January 2011 to 8 March 2011

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: lipophilic substance

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: 300 mg/kg was choosen as no data on the toxicity of the compound was known.

Doses:

300 and 2000 mg/kg bw

No. of animals per sex per dose:

6 females per dose level

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> clinical observations and mortality: 30 minutes, 2 hrs, 4 hrs and 6 hrs after the administration and thereafter daily
> body weight: on day 0, 7 and 14
- Necropsy of survivors performed: yes

Statistics:

not applicable

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed during te observation period.

Clinical signs:

Slight signs of toxicity were observed.
On the day of application after 30 minutes 2 hrs and 4 hrs, a hunched posture and/or piloerection were observed in 6 animals (3 in group 1 and 3 in group 2) receiving a dose of 300 mg/kg bw. After 4 hrs and 6 hrs the rats showed normal behaviour. From day 1 to the end of the observation period on day 14 all animals were free of any abnormalities.
On the day of application after 30 minutes piloerection was observed in 3 animals of group 3 receiving a dose of 2000 mg/kg bw. After 2 hrs and 4 hrs the rats showed a hunched posture and piloerection, whereas only piloerection was observed fter 6 hrs. From day 1 to the end of the observation period on day 14 all animals were free of any abnormalities.
In group 4 receiving a dose of 2000 mg/kg bw, piloerection was observed in all animals (3) on the day of application after 30 minutes, 2 hrs, 4 hrs and 6 hrs. From day 1 to the end of the observation period on day 14 all animals were free of any abnormalities.

Body weight:

The development of the body weight was normal in all animals.

Gross pathology:

There were no pathological signs detected in the necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

oral LD50 > 2000 mg/kg bw in rat (no mortality)

Executive summary:

In an acute oral toxicity study according to OECD TG 423 and GLP (Vaeth A., 2011), scored as validity 1 according to Klimisch criteria, groups of fasted Wistar rats (6 females/dose level) were given a single oral dose of « Corn oil, peroxidised » in olive oil at the doses of 300 and 2000 mg/kg bw and observed for 14 days. Clinical signs and mortality were checked frequently during the hours following administration of the test substance, and at least once a day thereafter. Body weight was measured just before administration of the test substance on day 0 and then on days 7 and 17.

Under the experimental conditions, the oral LD50 of the test substance « Corn oil, peroxidised » is higher than 2000 mg/kg in rats.

No mortality was observed during the observation period. On the day of application after 30 minutes to 6 hrs, a hunched posture and/or piloerection were observed in animals receiving the doses of 300 and 2000 mg/kg bw. After 4 hrs or 6 hrs the rats showed normal behaviour. From day 1 to the

end of the observation period on day 14 all animals were free of any abnormalities.

The development of the body weight was normal in all animals.

There were no pathological signs detected in the necropsy.

No classification for acute oral toxicity is warranted based on the absence of mortality up to a limit dose level, according to the criteria of EU GHS.

This study is classified as acceptable, as it is performed according to OECD guideline and GLP.