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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Remarks:
acute toxic class method
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 16th June 2004 to 30th June 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
OECD guideline 423. GLP study.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Physical state: a blue powder

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS- Age at study initiation: 7 weeks- Weight at study initiation: 183-190 g- Housing: stainless-steel cages- Water (e.g. ad libitum): free bottle of water intake tap water- Acclimation period: 2 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 23ºC- Humidity (%): 55%

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
1% sodium carboxymethylcellulose solution
Doses:
2000 mg/kg
No. of animals per sex per dose:
2 groups of 3 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: 1time/day- 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.
Mortality:
No mortality was observed
Clinical signs:
No clinical signs
Body weight:
No effects
Gross pathology:
No autopsy findings for pathological damage.
Other findings:
Bluish feces in the 3 female rats of a group at 1st day after administration derived from the color of the test material.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified.
Remarks:
Criteria used for interpretation of results: EU. According to GHS criteria the test item could be classified in the Category 5 or as " GHS criteria not met", further information is needed regarding acute oral toxicity taking 5000mg/kg bw
Conclusions:
The result was as follows: LD50 >2000 mg/kg bw
Executive summary:

The aim of the test was to study the single dose oral toxicity of the test material according to OECD Test Guideline 423.

The test material was studied in 6 female rats (2 groups with 3 female rats per group) in a single dose oral toxicity test at 2000 mg/kg bw. On observation for general signs, only bluish feces, derived from the color of the test material, were noted. The result was as follows: LD50 >2000 mg/kg bw