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Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
repeated dose toxicity: oral
Remarks:
other: Short-term
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1996

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: 92/69/EWG, B.7; OECD 407
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)isophthalamide
EC Number:
419-710-0
EC Name:
N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)isophthalamide
Cas Number:
42774-15-2
Molecular formula:
C26H42N4O2
IUPAC Name:
N,N'-bis(2,2,6,6-tetramethyl-4-piperidyl)isophthalamide
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
other: rat, Sprague-Dawley

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 1 % wässrige Carboxymethylcelluloselösung
Details on oral exposure:
Method of administration:
Magensonde
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 50 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 500 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 500 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
There were no treatment-related deaths.
Substance-induced effects on body weight gain,
Food or water consumption were not observed.
Laboratory findings:
In the high dose were in the males a
Lowering of the erythrocyte cell number and an increase in the
central blood volume diagnosed. Clinical-chemical
was in the males in the medium dosage,
seen increased activity of ASAT. Investigations
Urine showed no treatment-related effects.
Effects in the institution:
Macroscopic and histomorphological investigations
There were no findings on substance-induced functional
or morphological changes in both sexes.

Effect levels

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Dose descriptor:
NOAEL
Effect level:
500 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOAEL
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:
Classified as: Not classified