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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:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD 423 and EC test method B.1

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
orange solid powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
6 animals used in an airconditioned room with free access to standardised pelleted laboratory animal diet and tap-water.

Administration / exposure

Route of administration:
oral: gavage
Details on oral exposure:
single dosage on day 1
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
3 animals
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
0
Clinical signs:
lethargy in one male on day 1. Red staining on the neck in one female days 1 and 2. Yellow staining by the test substance of the faeces and several body parts was noted between days 1 and 5.
Body weight:
body weight gain shown by the animals over the study period was considered to be similar to that expected of normal untreated animals of the same strain and age.
Gross pathology:
No abnormalities reveiled.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 value of D-100 in Wistar rats was established to exceed 2000 mg/kg body weight.
Executive summary:

The oral LD50 value of D-100 in Wistar rats was established to exceed 2000 mg/kg body weight.