METHYL (3-OXO-2-PENTYLCYCLOPENT-1-EN-1-YL)ACETATE

Repeated dose toxicity: oral

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

1

Dose descriptor:

NOAEL

Effect level:

150 mg/kg bw/day (nominal)

Basis for effect level:

other: original NCD unit is mg/kg/day.

2

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.