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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC Directive, Annex V - Method B7 and OECD No. 407.
GLP compliance:
yes
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Method of administration:
Oral by gavage.
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 15 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
Clinical signs:

No treatment-related death occurred during the treament
period.

Ptyalism was noted in almost all the animals given 150
mg/kg/day. No other clinical signs were recorded.


Body weight and food consumption:

Except for a slight reduction of body weight gain in males
receiving 150 mg/kg/day, there were no noteworthy
differences between control and treated groups.


Functional observation battery:

No specific signs of a neurotoxic action of the test
substance were noted.

Laboratory findings:
Hematology:

There were no noteworthy differences between control and
treated groups among hematological parameters.


Blood biochemistry:

No treatment-related abnormalities were observed among the
blood biochemical parameters.


Urinalysis:

No treatment-related qualitative or quantitative changes
were observed.

Effects in organs:
Organ weight:

No differences of toxicological importance were noted
between treated and controls groups.


Macroscopic and microscopic examinations:

No relevant findings were noted in any treated groups.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
150 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
50 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:
The administration of Pseudo Kharismal daily by Gavage for four weeks to rats did not produce any signs of toxicity at 15 and 50 mg/kg/day. At 150 mg/kg/day, the only effects noted were slight clinical signs (ptyalism) in both sexes and decreased body weight gain in males. No specific signs of a neurotoxic action were recorded. Consequently, under the experimental conditions, the No Observed Effect Level (NOEL) is established at 50 mg/kg/day.
Executive summary:

The administration of Pseudo Kharismal daily by Gavage for four weeks to rats did not produce any signs of toxicity at 15 and 50 mg/kg/day. At 150 mg/kg/day, the only effects noted were slight clinical signs (ptyalism) in both sexes and decreased body weight gain in males. No specific signs of a neurotoxic action were recorded. Consequently, under the experimental conditions, the No Observed Effect Level (NOEL) is established at 50 mg/kg/day.