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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study design comparable to OECD Guideline 401. Study in Japanese with complete English translation.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity: 98.9%
Lot No.: 8X04
Supplier: Nippon Oil & Fats Co., Ltd

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River japan, Yokohama
- Age at study initiation: 6 weeks
- Weight at study initiation: m= 165-175g, f= 123-130g
- Fasting period before study: 3 hr
- Housing: 5 in a stainless steel wire mesh cage
- Diet (e.g. ad libitum): Pelleted diet, lot No: 980910, Oriental Yeats Co., Ltd
- Water (e.g. ad libitum): Tap water
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.3-24.4°C
- Humidity (%): 51-67%
- Air changes (per hr): 20 per hr
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: not given
- Amount of vehicle (if gavage): 0.5 mL per 100 g bw
- Justification for choice of vehicle: corn oil
- Lot/batch no. (if required): V5E1697
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
Statistical analysis was not performed.

Results and discussion

Preliminary study:
no animals died in the preliminary study at 2000 mg/kg bw
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 2 000 mg/kg bw
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Mortality:
No animal died
Clinical signs:
Neither males nor females showed abnormal general conditions throughout the observation period.
Body weight:
The body weights of male and female rats were increased on Day 7 and Day 14.
Gross pathology:
No pathological lesions were observed in males or females in the necropsy at the end of the observation period.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 values were more than 2000 mg/kg for both sexes.
Executive summary:

In a study performed according to OECD 401, no deaths occurred in either sex of rats during the observation period. Abnormalities of general condition were not observed in any males or females during the observation period. Therefore, the LD50 is >2000 mg/kg.