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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:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: GB/T 21603-2008 Chemicals - Test method of acute oral toxicity
Version / remarks:
Chinese National Standard
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: bulk
Details on test material:
Batch ST02697671
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:ST02697671
- Storage condition of test material: room temperature, avoid humidity and direct sunlight

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: TianQing biotechnology Ltd. ChangSha, China
- Weight at study initiation: 186 - 208 g bw
- Fasting period before study: overnight
- Housing: SPF Barrier environment
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21°C
- Humidity (%): 57 - 68 %

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 333.3 mg/ml
MAXIMUM DOSE VOLUME APPLIED: 1.5 mL/100 g bw

Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5 male + 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
no detectable clinical signs occurred
Body weight:
increased body weights at day 7 and day 14.
Gross pathology:
no abnormal necropsy findings

Applicant's summary and conclusion

Conclusions:
The acute oral LD50 of REWOSOFT TE 19L for both male and female rats was estimated to be over 5000 mg/kg bw.