4,4'-[(1,10-dioxodecane-1,10-diyl)bis(oxy)]bis(2,2,6,6-tetramethylpiperidine-1-oxidanyl)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-1 (Acute Oral Toxicity)

Version / remarks:

November 1984

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1,10-bis(2,2,6,6-tetramethyl-1-piperidinyloxy)-1,10-dioxodecane

EC Number:

417-440-8

EC Name:

1,10-bis(2,2,6,6-tetramethyl-1-piperidinyloxy)-1,10-dioxodecane

Cas Number:

2516-92-9

Molecular formula:

C28 H50 N2 O6

IUPAC Name:

bis(1-hydroxy-2,2,6,6-tetramethylpiperidin-4-yl) decanedioate

Details on test material:

Identification code (lab) = TKA 40075

Specific details on test material used for the study:

Batch Ba #13

Test animals

Species:

rat

Strain:

other: HSD:(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc., Houston, Texas
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: Young adult
- Weight at study initiation:
Males (199-226 g)
Females (197-211 g)
- Fasting period before study: at least 16 hours prior to treatment
- Housing:
Cage Type: Suspended, wire bottom, stainless steel
Housing: 1 per cage
Transfer to Clean Cages: Weekly
Litter Pan Lining: Paper and aspen beddmg
Litter Pan Lining Change: Three times weekly
Food: Purina Formulab Chow #5001; available ad libitum
Water Type: Tap, available ad libitum
Water System: Automatic
- Acclimation period: 1 week


IN-LIFE DATES: From: 06/10/1992 To: 24/10/1992

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
All animals were treated with 5050 mg/kg (12.6 ml/kg) of a 40.0% w/v concentration of the test material m deionized water.

MAXIMUM DOSE VOLUME APPLIED: 5050 mg/kg

Doses:

5050 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Observations for mortality and signs of pharmacologic and/or toxicologic effects were made at least three tunes on the day of treatment and at least once daily thereafter for 14 days (day of treatmentconsideredDay0). Individualbodyweightswererecordedjustpriortotreatmentandon Days 7 and 14. A gross necropsy was conduaed on each animal at termination of the smdy.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 050 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: All animals appeared normal for the duration of the study.

Gross pathology:

The gross necropsy conduaed on all animals at termination of the smdy revealed no observable abnonnalities in any of the animals.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No animals died during the smdy. The acute oral LDjo for GUlO-415, as indicated by the data, is greater than 5050 mg/kg (12.6 ml/kg) when administered as a 40.0% w/v concentration in deionized water to albino rats.

Executive summary:

An acute oral toxicity study (EPA 81 -1) was conducted on male and female albino rats using test material GU 10-415.

The test material was administered as a 40.0% w/v concentration in deionized water. Five males and five females were dosed at a level of 5050 mg/kg (12.6 ml/kg).

No animals died during the study. The acute oral LD50 for GU 10-415, as indicated by the data, is greater than 5050 mg/kg (12.6 ml/kg) deionized water to albino rats.