Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
other information
Study period:
1984
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Principles of method if other than guideline:
subacute toxicity test
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tributylamine, not further specified

Test animals

Species:
other: rat, mouse
Strain:
other: white
Sex:
not specified

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
3 days
Frequency of treatment:
1x/d
Doses / concentrations
Remarks:
Doses / Concentrations:
1/3 of LD50
No. of animals per sex per dose:
no data
Control animals:
other: no data specified

Results and discussion

Effect levels

Dose descriptor:
LOAEL
Effect level:
ca. 36 mg/kg bw/day (nominal)
Sex:
not specified
Basis for effect level:
other: effects on liver enzymes metabolising xenobiotics, lipid peroxidation, intercellular shift from SH- to SS-groups

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No conclusions can be drawn based on the available data.
Executive summary:

Intraperitoneal injections of 1/3 the LD50 (approx. 36 mg/kg bw) into white rats and mice of unspecified strain produced effects on xenobiotic-metabolising liver enzymes 24 h after the last dosing: there was a prolongation of the hexobarbital sleeping time, an increased activity of the monoamine oxidase and a decrease in the activity of the activity of the succinate dehydrogenase. The amount of urinary antipyrine metabolites were reduced. There was also an increase in lipid peroxidation and a decrease in the content of intercellular free SH groups as well as an increase in SS-groups (Sidorin et al., 1984).