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

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test conducted according to GLP and OECD 407, EU Method B.7.

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

1991

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))

Deviations:

not specified

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of bis[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl] decanedioate and 1,1'-bis[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl] 10,10'-{octane-1,8-diylbis[oxy(2,2,6,6-tetramethylpiperidine-1,4-diyl)]} didecanedioate

IUPAC Name:

Reaction mass of bis[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl] decanedioate and 1,1'-bis[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl] 10,10'-{octane-1,8-diylbis[oxy(2,2,6,6-tetramethylpiperidine-1,4-diyl)]} didecanedioate

Constituent 2

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:

Constituent 1: C44H84N2O6 Constituent 2 : C80H150N4O12

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

Constituent 3

Reference substance name:

Reaction mass of bis[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl] decanedioate and 1,1'-bis[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl] 10,10'-{octane-1,8-diylbis[oxy(2,2,6,6-tetramethylpiperidine-1,4-diyl)]} didecanedioate

IUPAC Name:

Reaction mass of bis[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl] decanedioate and 1,1'-bis[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl] 10,10'-{octane-1,8-diylbis[oxy(2,2,6,6-tetramethylpiperidine-1,4-diyl)]} didecanedioate

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:

Test duration: 28 days

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

Basis for effect level:

other: Original NCD unit is mg/kg/day

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.