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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
other: ECHA inquiry result
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: Albino Sprague-Dawley CD rats

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: The test material was initially ground to a fine powder, then approximately 100 grams of Certified Rodent Diet was added and mixed until homogeneous. This mixture was than mixed with an appropriate amount of diet to yield the proper dose levels.
Details on oral exposure:
diet
Duration of treatment / exposure:
test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 250 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 250 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
No mortality
The statistically significant decrease in mean alkaline
phosphatase value of the females treated with 1000 mg/kg/d
was not accompanied by changes in liver weights values or
macroscopic or microscopic changes in the liver and was not
considered to be toxicologically significant.
Laboratory findings:
No adverse effects
Effects in organs:
No treatment related macro- and microscopic findings

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day
Dose descriptor:
NOEL
Effect level:
1 000 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
classified as : not classified