Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment

Data source

Reference
Title:
Die pharmakologischen Eigenschaften des Triacetonamines
Author:
Chodera, A., Frencel, I., Szpunar, K.
Year:
1964
Bibliographic source:
Pharmazeutische Zentralhalle fuer Deutschland, 103, 17-23

Materials and methods

Principles of method if other than guideline:
Method: other: no data
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS

TS-Freetext:
Triacetoneamine hydrochloride

Test animals

Species:
mouse
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
other: s.c.
Duration of treatment / exposure:
30 days
Frequency of treatment:
once per day
Doses / concentrations
Remarks:
Doses / Concentrations:
250 mg/kg bw
Control animals:
other: no data specified
Details on study design:
Post-exposure period: no data

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
> 250 mg/kg bw/day
Sex:
not specified

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

RS-Freetext:
No reduction in body weight. No indications of substance related  intoxictation. (no further data given).

Applicant's summary and conclusion