BRUGGOLITE® FF6

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 1998 - September 1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Details on test material:

none

Test animals

Species:

other: rat, Wistar Crl:WI BR (SPF)

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: 35-42 days
- Weight at study initiation:
males: 225.4 g +/- 5.1g; n=5
females: 175.2 g+/- 1.5 g; n=5
- Fasting period before study:
- Housing: Altromin Type S8/15; granulated soft wood bedding
- Diet: (ad libitum): Altromin 1326, pellet standard diet, batch# 140698/1206
- Water (ad libitum): tap water (municipal supply), Makrolon bottles, changed daily

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 50-70 %
- Air changes (per hr): air conditioned
- Photoperiod (hrs dark / hrs light): artificial light was set to give a ccle of 12 hours light and 12 hours dark; the light phase was from 6.30 a.m. - 6.30 p.m

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

distilled water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 6g ad. 30 ml
- Amount of vehicle (if gavage): 6g ad. 30 ml

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight

Doses:

2,000 mg/kg body weight (b.w) using 5 males and 5 females. Individual doses were adjusted according to the body weight on the day of administration.

No. of animals per sex per dose:

2,000 mg/kg body weight (b.w) using 5 males and 5 female

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and morbidity continuously on the day of administration and once daily thereafter (in the morning). The animals were monitored for general clinical condition continuously on the day of administration and once daily thereafter (in the morning). Body weights were recorded on the day of administration and on days 7 and 14.
- Necropsy of survivors performed: At the end of the observation period all animals were killed by chloroform inhalation. All animals were examined externally. The cranial, thoracic and abdominal cavities were then opened and examined macroscopically.

Statistics:

body weights: Calculation of group mean values and standard deviations.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0

Clinical signs:

Signs of toxicity related to dose levels: On the day of administration of the test article a slight apathy was observed in all animals and a slight squatting position was shortly observed in one male and in two female animals. None of the animals showed furhter alterations of their general state of well-being and behaviour.

Body weight:

The body weight gain was not affected.

Gross pathology:

No macroscopic pathological findings in the animals.

Other findings:

none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is neither a toxic nor a harmful substance according to this acute oral toxicity study.

Executive summary:

Acute oral toxicity of the test item was tested in male and female Charles River Wistar rats.

The test article was administered at a single dose of 2000 mg/kg body weight by gavage.

Animals were examined for mortality, clinical signs, body weight gain and pathological alterations of organs at the end of a 14-day observation period.

None of the animals died during the course of investigation.

On the day of administration of the test article a slight apathy was observed in all animalsand a slight squatting position was shortly observed in one male and in two female animals.

No pathological findings were observed at necropsy. The body weight gain was not affected.

The LD₅₀ is > 2000 mg/kg body weight .