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Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
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:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
Qualifier:
according to guideline
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
A mixture of: bis(2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-1,10-decanedioate; 1,8-bis[(2,2,6,6-tetramethyl-4-((2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-decan-1,10-dioyl)piperidin-1-yl)oxy]octane
EC Number:
406-750-9
EC Name:
A mixture of: bis(2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-1,10-decanedioate; 1,8-bis[(2,2,6,6-tetramethyl-4-((2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-decan-1,10-dioyl)piperidin-1-yl)oxy]octane
Cas Number:
129757-67-1
Molecular formula:
C44H84N2O6
IUPAC Name:
2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl 2,2,6,6-tetramethyl-1-{[8-({2,2,6,6-tetramethyl-4-[(10-oxo-10-{[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl]oxy}decanoyl)oxy]piperidin-1-yl}oxy)octyl]oxy}piperidin-4-yl decanedioate; 2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl 2,2,6,6-tetramethyl-4-{[8-({2,2,6,6-tetramethyl-1-[(10-oxo-10-{[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl]oxy}decanoyl)oxy]piperidin-4-yl}oxy)octyl]oxy}piperidin-1-yl decanedioate; bis[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl] decanedioate

Test animals

Species:
rat
Strain:
other: Tif: RALF (SPF)
Sex:
male/female

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: Distilled water with 0.25% Tween 80
Details on oral exposure:
Method of administration: Magensonde (gavage)
Duration of treatment / exposure:
28DAYS
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 20 animals at 0 mg/kg bw/day
Male: 20 animals at 10 mg/kg bw/day
Male: 20 animals at 100 mg/kg bw/day
Male: 20 animals at 1000 mg/kg bw/day
Female: 20 animals at 0 mg/kg bw/day
Female: 20 animals at 10 mg/kg bw/day
Female: 20 animals at 100 mg/kg bw/day
Female: 20 animals at 1000 mg/kg bw/day

Results and discussion

Effect levels

Dose descriptor:
NOAEL
Effect level:
100 mg/kg bw/day (nominal)
Based on:
not specified
Sex:
not specified

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

No premature mortalities occurred. The body-weight gain was not impaired as a result of the treatment.

Laboratory findings:

Prolongation of the prothrombin time, which, however, was reversible in the animals from the recovery group, was observed among the males from the highest-dose group. Clinico-chemical findings, organ weights and the macroscopic investigation did not reveal any substance-related changes.

Effects in organs:

The histological examination revealed an increase in the extramedullar haematopoietic activity in the liver among the male animals from the high-dose group. No further substance-related changes (including neurological findings) were determinded.

Applicant's summary and conclusion

Conclusions:
Classified as: not classified.