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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:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline conform study, no information about age and weight of test animals

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS Hsd: Sprague Dawley® SD® rats
- Source: Harlan Sprague Dawley, Inc.
- Age at study initiation: not mentioned
- Weight at study initiation: not mentioned
- Fasting period before study: over night
- Housing: suspended stainless steel cages. All housing and care were based on the standards recommended by the Guide for the Care and Use of Laboratory Animals
- Diet (e.g. ad libitum): PMI Certified Rodent Meal ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 37-51
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: 16.03.2000 To: 30.03.2000

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Details on oral exposure:

VEHICLE PEG 400
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg bw
- 2000 mg/kg bw single oral dose (gavage)

Doses:
2000 mg/kg bw, 10 ml/kg, 200 mg/ml
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Clinical Observations
Limit test animals were observed for clinical abnormalities at approximately 1,
2, 4, 8 and 24 hours (post-dose) and daily thereafter (days 1-14). A general
health/mortality check was performed twice daily (in the morning and in the
afternoon).

Body Weights
Individual body weights were obtained for the limit test animals prior to fasting
(day -1), prior to dosing on day 0 and on days 7 and 14.

Food Consumption
Individual food consumption was recorded for all animals on days 0, 7 and 14.

Scheduled Euthanasia
All limit test animals were euthanized by carbon dioxide inhalation at study
termination (day 14) and necropsied. Body cavities (cranial, thoracic, abdominal
and pelvic) were opened and examined. No tissues were retained.
Statistics:
means and standard deviations

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Mortality:
No mortality occurred during the limit test.
Clinical signs:
The most notable clinical abnormalities observed during the study included
fecal/urine stain, mucoid/soft stools, diarrhea, congested breathing and dark
material around the nose/eyes.
Body weight:
Body weight gain was noted for all animals during the test period.
Gross pathology:
No gross internal findings were observed at necropsy on study day 14.
Other findings:
A slight decrease in food consumption was noted from day 7-14; however,
adequate food consumption was noted for all animals during the test period.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test, the acute oral LD50 was estimated to be greater than 2000 mg/kg in the rat.
Executive summary:

The single-dose oral toxicity was evaluated in Sprague-Dawley rats. A limit test was performed in which one group of five male and five female rats received a single oral administration of the test article at a dose of 2000 mg/kg body weight. Following dosing, the limit test rats were observed at 1,2,4, 8 and 24 hours post-dose and daily thereafter and weighed weekly. Individual food consumption was recorded weekly. A gross necropsy examination was performed on all limit test animals at the time of scheduled euthanasia (day 14). No mortality occurred during the limit test. The most notable clinical abnormalities observed during the study included fecal/urine stain, mucoid/soft stools, diarrhea, congested breathing and dark material around the nose/eyes. Body weight gain and adequate food consumption were noted for all animals during the test period. No gross internal findings were observed at necropsy on study day 14.