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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD method used

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996

Materials and methods

Principles of method if other than guideline:
Method: other: preliminary examination of OECD TG407
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Mitsuboshi Chemical Co., Ltd.: purity >99%

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: sesame oil, 0.5ml/100g bw
Doses:
0, 100, 250, 500, 100, 2000 mg/kg/day
No. of animals per sex per dose:
4

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw

Any other information on results incl. tables

(See also 7.5.1 Repeated dose toxicity: oral)

PRELIMINARY EXAMINATION
4 Males and 4 females were used for the 14 days Preliminary
Examination. Any toxicological effects in the clinical
signs, body weight, food consumption, urinary findings,
hematological findings, blood chemical findings and weight
of organs was not observed in any animal at upto 2000
mg/kg/day groups.
At necropsy enlargement of cecum was observed in all animals
at 2000 mg/kg/day group.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 (and LD0) was > 2000 mg/kg.
Main toxicological effect was enlargement of cecum in both sexes at 2000 mg/kg.