Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 June May 1995 to 28 June 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study conducted 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. The study report was conclusive, done to a valid guidelines and the study was conducted under GLP conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Substance type: yellow-brown to orange powder.
- Storage condition of test material: at 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: ~ 6 weeks old
- Weight at study initiation: Males 171 ± 8 g, females 135 ± 5 g.
- Fasting period before study: Overnight for approximately 18 hours prior to dosing, food was reinstated 3-4 hours after administration of the test material.
- Housing: 5 per sex per cage, in polycarbonate cages (48 x 27 x 20 cm) covered with a stainless steel lid.
- Diet (e.g. ad libitum): pelleted diet ad libitum.
- Water (e.g. ad libitum): filtered water ad libitum.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 30 to 70 %
- Air changes (per hr): 12 cycles/hour of filtered, non-recycled air.
- Photoperiod: 12 hr light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
(distilled)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg, the dose volume was adjusted according to the body weight determined on the day of treatment.

DOSAGE PREPARATION: The test solution was prepared in the vehicle on the day of treatment.
Doses:
2000 mg/kg bw of active material (corrected for purity)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Examinations and frequency of observations:
Clinical signs: Animals were observed frequently in the hours following administration, and then at least once daily thereafter for a period of 14 days. Any signs were recorded on an individual basis.
Mortality: Animals were checked frequently for mortality and signs of morbidity in the hours following administration and then twice daily thereafter.
Body weight: Animals were weight prior to administration and then on days 8 and 15.
Body weight gain of the treated animals was compared to a reference curve created at the test facility, of control animals with the same initial weight.
Necropsy: Animals were euthanized on day 15 and macroscopic examinations were performed.
Examination included; opening of the thoracic and abdominal cavities and examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any with signs of abnormalities).
No microscopic examinations were performed.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
act. ingr.
Mortality:
No mortality was observed at 2000 mg/kg.
Clinical signs:
No clinical signs of toxicity were observed.
Body weight:
No treatment related effects were observed on body weight gain.
Gross pathology:
Macroscopic examination revealed no abnormalities in the animals.

Any other information on results incl. tables

Table 1: Mean Body Weight and Mean Body Weight Gain (g)

Sex

Body Weight on Days

1

Gain

8

Gain

15

Male

171 (± 8)

80 (± 7)

252 (± 15)

64 (± 9)

316 (± 17)

Female

135 (± 5)

46 (± 16)

181 (± 15)

24 (± 4)

206 (±16)

(± Standard Deviation)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test, no signs of mortality or treatment related toxicity were observed in any of the animals exposed to the test material via oral gavage. Therefore the LD50 of the test material was determined to be > 2000 mg/kg bw in both male and female rats.
Executive summary:

The acute oral toxicity of the test material was determined in a study conducted under GLP conditions in accordance with the standardised guidelines OECD 401 and EU method B.1, using the fixed dose procedure.

Five male and 5 female Sprague-Dawley rats were exposed to the test material at 2000 mg/kg bw via oral gavage. The test material was dosed at 10 mL/kg bw in distilled water.

Under the conditions of the test, no overt signs of toxicity or mortality were observed in any of the treated animals, and body weight gain was normal. Furthermore, macroscopic examinations at necropsy revealed no abnormalities. Based on these observations the LD50 of the test material was determined to be > 2000 mg/kg bw in both male and female rats.