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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation
Remarks:
GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
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
- Source: IFFA-CREDO, 69592 L’Arbresle, France
- Age at study initiation: 5 weeks
- Weight at study initiation: 146.6 – 160.9 g for males, 124.1 – 133.6 g for females
- Fasting period before study: 18 h
- Housing: 2 animals per cage, in Makrolon cages (37.5 x 23.5 x 16 cm), stainless streel grid lid, sawdust bedding
- Diet: ad libitum A04C maintenance diets pellets, UAR – 9130 Villemoisson / Orge – France
- Water: ad libitum potable water, Chateau’eau SA, 59110 La Madeleine, France
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 50 ± 10
- Air changes (per hr): >12
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle (if gavage): 10 mL/kg bw
Doses:
2 g/kg bw
No. of animals per sex per dose:
6
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were carefully observed before and just after dosing, 1 hour and 3 hours after administration. After that animals were observed daily. Animals were weighted on day 0, day 3, day 7, day 10 and day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: Feed and water consumption
Statistics:
Differences in the clinical observations and the observations at necropsy were analyzed using the chi-square test. Means and standard types were calculated with Excel for the following parameters: body weight, feed and water consumptions. Student t-test was used to compare the body weights between the 2 groups.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured.
Clinical signs:
No test item related clinical signs were observed. Animal behavior of treated animals was considered as normal.
Body weight:
- Male, control group, day 14: 277.1 - 300.6 g
- Male, test group, day 14: 272.6 - 301.3 g
- Female, control group, day 14: 185.0 - 206.0 g
- Female, test group, day 14: 183.2 - 224.4 g
Gross pathology:
No treatment related abnormalities were observed.
Other findings:
- Other observations: feed and water consumption were comparable between test group and control group

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met