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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 March 1994 - 16 March 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
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
Details on test material:
Appearance: pink powder
Storage conditions: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Sprague-Dawley ICO:OFA-SD (IOPS Caw)
- Age at study initiation: approximately 6 weeks
- Weight at study initiation (means): 164 ± 4g for the males, 161 ± 5 g for the females
- Fasting period before study: 18 hours before treatment; food was replaced approximately 4 hours after treatment
- Housing: animals were housed in groups of 4 to 7 animals of the same sex in polycarbonate cages (48 x 27 x 20 cm) covered with a stainless steel lid during the acclimatisation period and groups of 5 animals of the same sex during the study. Each cage contained graded, dust-free sawdust.
- Food consumption (e.g. ad libitum): ad libitum
- Water consumption (e.g. ad libitum): ad libitum filtered water contained in bottles
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 ± 20 % relative humidity
- Air changes (per hr): 13 cycles/hour of non-recycled and filtered air
- Photoperiod (hrs dark / hrs light): 12hr/12hr

In-life dates: From 02 to 16 March 1994

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous solution of methylcellulose at 0.5 %
Details on oral exposure:
DOSAGE PREPARATION:
On the day of the treatment, the test material was ground using a mortar and pestle, then was suspended in the vehicle.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg


Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
other: The body weight of the animals treated with the test material was compared to laboratory historical control data for animals dosed by the oral route.
Details on study design:
DETAILS ON STUDY DESIGN
- Duration of observation period following administration: 14 days
- Frequency of observations: the animals were observed frequently after administration of the test material, for detection of possible treatment-related clinical signs and for mortality or signs of morbidity. Observations of the animals were made at least once a day for clinical signs and at least twice a day for mortality.
- Frequency of weighing: Animals were weighed just before administration of the test material and then on days 5, 8 and 15.
- Necropsy of survivors performed: yes (day 15). Animals were sacrificed by excess CO2 inhalation.
- Other examinations performed: macroscopic examination at necropsy (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organ with obvious abnormalities).

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No deaths occured during the observation period.
Clinical signs:
No clinical signs were observed during the study.
Body weight:
The body weight gain of the animals was normal.
Gross pathology:
The macroscopic examination of the main organs of the animals sacrified at the end of the study revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the experimental conditions of this study, the oral LD50 of the test material was > 2000 mg/kg in rats. No signs of toxicity were observed at this dose; the test material therefore requires no classification in accordance with EU criteria.
Executive summary:

The acute oral toxicity of the test material was evaluated in a limit test which was conducted in accordance with the standardised guideline OECD 401.

Groups of fasted, 6 week old Sprague-Dawley rats (5 per sex) were given a single oral dose of the test material in an aqueous solution of methylcellulose at 0.5 % at a dose of 2000 mg/kg bw (dose volume 10 mL/kg) and observed for 14 days.

No mortality and no clinical signs were observed during the study. The body weight gains of the treated rats were normal. No gross abnormalities were observed at necropsy.

The oral LD50 (males and females) was >2000 mg/kg bw and therefore the test material is not classified for acute oral toxicity in accordance with EU criteria.