Life Power® L1

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Supplier: Institut für Labortierkunde und -genetik, A-2325 Himberg, Austria.
Age: Approximately 8 weeks (males and females) at the time of the administration.
Body weight at the administration: 190 g for males, 154 g for females.

Room temperature: Average of 22 °C (continuous control and recording).
Relative humidity: Average of 56 % (continuous control and recording).
Air exchange: 12 per hour.
Light: Artificial light from 6 a.m. to 6 p. m.
Cages: Single caging in Makrolon cages type III (39 cm x 23 cm x 18 cm). Wire mesh lids.
Bedding material: Aspen wood chips
Environmental enrichment: Nibbling wood bricks (10 cm x 2 cm x 2 cm) and nesting material, both from the same material and source as the bedding material, were offered to the animals
Feed: Altromin 1324 forte, gamma irradiated with 25 kGy 60Co, ad libitum. Exception: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.
Water: Tap water from an automatic watering system, ad libitum.
Acclimatisation: At least 5 days.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

A stomach intubation was performed. Dose volume: 10 mL/kg bw.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males + 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: Observations were performed within the periods 0- 0.5, 0.5 - 1, 1 - 2, 2- 4 and 4- 6 hours after administration of the test substance and then at least once a day for a total of 2 weeks.
- Frequency of weighing: Body weights were determined before the administration, 7 days p.a. and 14 days p.a.
- Necropsy of survivors performed: yes.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived until the scheduled termination of the study.

Clinical signs:

Observations in life
4/5 males and 4/5 females were normal during the whole observation period. Hunched posture in 1/5 males and females each noted 0.5 h p.a. is attributed as a sign of discomfort or of reduced well-being.

Body weight:

Males and females: Body weights and body weight gain were inconspicuous in all animals in the first week. In the second week a low body weight gain was noted in 1/5 females.

Gross pathology:

Necropsy findings
No abnormal findings were made post mortem.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No mortality, no relevant signs in life and at necropsy were detected. The LD50 is above 2000 mg/kg bw.

Executive summary:

Methods and investigations were performed in accordance with the EU method B1., and the OECD Guideline 401, 1987.

The test substance, freshly suspended in corn oil, was administered once orally by stomach intubation to 5 male and 5 female Sprague Dawley rats. The dose was 2000 mg per kg body weight.

Investigations

• Body weights: before the administration, 7 and 14 days after the administration.

• Clinical observations: at least once per day.

• Necropsy: 14 days p.a.

No mortality, no relevant signs in life and at necropsy were detected. The LD50 is above 2000 mg/kg bw.