Registration Dossier

Toxicological information

Repeated dose toxicity: other routes

Currently viewing:

Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Unsuitable test system

Data source

Reference
Reference Type:
publication
Title:
Long-Term Treatment with 2,5-Hexanedione Has No Effect on the Specific Activity of Some Brain and Liver Glycolytic Enzymes of Adult Rats
Author:
M.E. Pereira, A.M. Bordignon, C. Bürger, C.I. Huang, J.B.T. Rocha
Year:
1991
Bibliographic source:
Brazilian J. Med Biol. Res. 1991, 24, 735-740

Materials and methods

Test guideline
Qualifier:
no guideline followed
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
no data

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
female Wistar rats, 40-45 days old, 150-170 g bw, 12 h light/12 h dark cycle

Administration / exposure

Route of administration:
subcutaneous
Vehicle:
other: 100 mM NaCl, 10 mM K-Phosphate buffer, pH = 7
Details on exposure:
200 mg/ kg bw 2,5- Hexanedione

Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
40 days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
200 mg/ kg bw
No. of animals per sex per dose:
one dose group
Control animals:
yes
Details on study design:
40 days treatment, examination of brain and liver after treatment.
Enzymes: Lactic dehydrogenase, Enolase, Malate dehydrogenase, Liver glycogene level

Examinations

Observations and examinations performed and frequency:
Body weight, food and water intake were measured every 6 days.
Sacrifice and pathology:
Decapitation, removal and analysis of brain and liver.
Statistics:
no data

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
reduced body weight gain
Food consumption and compound intake (if feeding study):
no effects observed
Water consumption and compound intake (if drinking water study):
effects observed, treatment-related
Description (incidence and severity):
increase

Effect levels

Dose descriptor:
other: enzyme activity
Effect level:
ca. 200 mg/kg bw/day
Based on:
test mat.
Sex:
female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Reduced weight gain, increased water intake, no changes in enzyme activity in brain and liver.