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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 31 MAY 2006 to 23 Jun 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (EU method B.1 tris; OECD TG 423)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(2-methoxyphenyl)azo]-3-oxobutyramide
EC Number:
279-914-9
EC Name:
N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(2-methoxyphenyl)azo]-3-oxobutyramide
Cas Number:
82199-12-0
Molecular formula:
C18H17N5O4
IUPAC Name:
2-[(1E)-2-(2-methoxyphenyl)diazen-1-yl]-3-oxo-N-(2-oxo-2,3-dihydro-1H-1,3-benzodiazol-5-yl)butanamide
Test material form:
solid: bulk

Test animals

Species:
rat
Strain:
other: HanRCC: WIST (SPF)
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd, Laboratory Animal Services, Füllinsdorf, Switzerland
- Age at study initiation: 12 weeks
- Fasting period before study: 18 to 19 h
- Housing: Macrolon cages (type 4) in groups of three
- Diet: peletted standard Provimi Kliba 3433 rat/mouse maintenance diet (batch no. 001/06, Provimi Kliba AG, Kaiseraugst, Switzerland); ad libitum
- Water: community tap water; ad libitum
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3
- Humidity (%): between 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/mL
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
2 groups of 3 animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: at least daily
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no animals died within the 14 day observation period
Mortality:
- no deaths occurred
Clinical signs:
other: - all animals expressed mild clinical signs of toxicity following the treatment - slight ruffeled fur was noted in 3 animals from 30 minutes reading until day 2 and in 1 animal from the 1hour reading until day 3 - hunched posture was seen, respectively, i
Gross pathology:
- animals killed at the end of the observation period showed no macroscopically visible changes

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Single application of the limit dose of 2000 mg test substance per kg bw did not cause lethality in female HanRCC: Wist rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw.
Executive summary:

Female rats were subjected to test acute oral toxicity according to the acute class method (OECD TG 423, Limit test). The test substance was administered by gavage at the limit dose of 2000 mg/kg bw to two groups of 3 animals. All treated animals expressed mild clinical signs of toxicity following the treatment. A slightly ruffled fur was observed in some animals which lasted until day 3, at the most. Moreover all animals showed a hunched posture for a few hours after the treatment.

No animal died within the observation period, resulting in a LD50 > 2000mg/kg bw.