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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:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Pre-dates GLP and guidelines, insufficient information on study methods and findings
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1960
Report Date:
1960

Materials and methods

Test guideline
Guideline:
other: No test guideline referenced

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Haskell batch number 2489

Test animals

Species:
rat
Strain:
other: ChR-CD
Sex:
male

Administration / exposure

Route of administration:
other: Ingestion
Details on oral exposure:
The animals were dosed 5 times a week for 2 weeks, receiving in total 10 doses of 2200 mg/kg (20% in peanut oil) each dose
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
2 weeks (10 doses)
Frequency of treatment:
daily 5/7 days for 2 weeks
Doses / concentrations
Remarks:
Doses / Concentrations:
2200 mg/kg
Basis:
actual ingested
No. of animals per sex per dose:
6

Examinations

Observations and examinations performed and frequency:
Clinical signs and bodyweights of the animals were measured but frequency was not reported.

At 4 hours after the 10th dose, 3/6 animals were killed, necropsied and tissues examined macroscopically. The remaining 3/6 animals were allowed a 10 day recovery period prior to sacrifice and necropsy examination.

Results and discussion

Results of examinations

Clinical signs:
effects observed, treatment-related
Description (incidence and severity):
slight stiffness in hind legs and irritability
Mortality:
mortality observed, treatment-related
Description (incidence):
slight stiffness in hind legs and irritability
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
slowed rate of weight gain
Gross pathological findings:
no effects observed
Details on results:
Repeated high sub-lethal doses of 2200 mg/kg caused signs of mild cumulative toxicity from which the rats rapidly recovered when dosing ceased. Tissue changes were not observed grossly or microscopically in the 3 rats killed 4 hours after the 10th treatment or in the 3 killed 10 days later.
It is concluded that the test item has a low order of cumulative oral toxicity under the conditions described.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Whilst the information supplied following 10 treatments of 2200 mg/kg is suggestive of a low order of repeat dose toxicity there is insufficient information on study methods and observations. There is no indication of which tissues were examined at necropsy or which tissues were processed microscopically for examination.