Registration Dossier

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 May 1988 to 20 February 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP study in accordance with internationally recognised guideline. Significant excursions outside temp and humidity ranges.  No functional observation battery tests as per OECD protocol. Homogeneity and stability studies were performed.  Analysis of dietary concentrations was carried out. The findings were well reported and accurate

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

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

Administration / exposure

Route of administration:
oral: feed
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
Test duration: 90 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 20 animals at 0 mg/kg bw/day
Male: 20 animals at .05 mg/kg bw/day
Male: 20 animals at .5 mg/kg bw/day
Male: 20 animals at 5 mg/kg bw/day
Female: 20 animals at 0 mg/kg bw/day
Female: 20 animals at .05 mg/kg bw/day
Female: 20 animals at .5 mg/kg bw/day
Female: 20 animals at 5 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
No dose related changes with ADK STAB PEP-36

Laboratory Findings:
No change in biochemical parameters in blood and urine.

Effects in organs:
Red spots observed in the lung in especially in males. A number of histopathological abnormalities were observed in the lung, renal, hepatic,
pancreas, heart, prostate glands lymph in treated animals but were comaprable with control animals. The effects are not therefore not considered to be connected with the treatment.

Organ weights: No change in weight

The dose of 5% is considered a no-effect level

.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
>= 2 675 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Basis for effect level:
other: see 'Remark'
Dose descriptor:
NOAEL
Effect level:
>= 3 390 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: see 'Remark'

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Not classified