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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:
other: reliability not verifiable
Rationale for reliability incl. deficiencies:
other: no data provided

Data source

Reference
Reference Type:
other: no data provided
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
GLP compliance:
not specified

Test material

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
400
Duration of treatment / exposure:
28 days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:

Basis:
no data
No. of animals per sex per dose:
5 males / 5 females per dose
Control animals:
not specified

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Details on results:
clinical observation:
Red discolored extremities were observed in the animals of the high dose group (1000 mg/kg) starting with day 21.

clinical chemistry/haematology:
No changes of toxicological significance at termination of the treatment.

necropsy findings/histopathology:
There was no evidence of histopatological findings resulting from treatment with the substance.

Two female animals died spontaneously on day 17 of the test, due to a possible intubation error.

Effect levels

Dose descriptor:
NOEL
Effect level:
1 000 other: mg/kg bw/day
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no adverse effects up to the highest dose tested

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Based on the results of this OECD 407 study, the NOAEL was considered to be 1000 mg/kg body weight/day.

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