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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:
2007-01-06 to 2007-01-16
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP and guideline study with minor deviations (details e.g. for housing conditions were not provided).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted December 17, 2001.
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Boyertown, PA
- Age at study initiation: approx. 9 weeks
- Weight at study initiation: Body weight range in males was 238 - 274 grams and in females was 172 - 206 grams
- Fasting period before study: 16 - 20 h
- Housing:The animals were identified by cage notation and indelible body marks, and housed in suspended wire mesh cages; 1/cage. Bedding was placed beneath the cages and changed at least three times/week.
- Diet: Fresh PMI Rodent Chow (Diet #5021) was freely available
- Water: Ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Temperature was controlled
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 0.55 mL
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 1, 2 and 4 hours postdose and once daily thereafter for 14 days for toxicity and pharmacological effects. All animals were observed twice daily for mortality. Body weights were recorded immediately pretest, weekly and at termination.
- Necropsy of survivors performed: All animals were examined for gross pathology.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All ten animals survived the 2000 mg/kg oral dose
Clinical signs:
Instances of chromorhinorrhea, lethargy, ataxia, hunched posture, few feces, bloated abdomen,
chromodacryorrhea, soiling of the anogenital area and/or emaciation ware noted in several rats
during the study. Three rats were normal throughout the entire observation period.
Body weight:
One female was noted to be emaciated on Days 13 and 14; otherwise, body weight changes were normal.
Gross pathology:
The following abnormalities were noted in one or two rats at necropsy: slight or scattered red areas on the thymus, red areas on the intestines that ranged from slight or scattered to moderate or few; and/or slight or scattered soiling of the anogenital area. Bifurcated spleen was noted in two rats, although this abnormality should not be considered to be a result of treatment with the test article.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS