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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPP 81-5 (Acute Dermal Irritation)

Version / remarks:

November, 1984.

Deviations:

no

GLP compliance:

yes (incl. QA statement)

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

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:
Ray Nichols Rabbitry, Lumberton, Texas
- Age at study initiation:
Young adult (3 to 6 months)
- Weight at study initiation:
Not specified
- Acclimation period: At least five days
Cage Type: Suspended, wire bottom, stainless steel Housing: One per cage
Transfer to Clean Cages: Weekly
Litter Pan Linmg: Paper
Litter Pan Lining Change: Daily
Food: Purina Rabbit Chow; presented in measured amounts Water Type: Tap; available ad libitum
Water System: Automatic


IN-LIFE DATES: From: June 9, 1992 To: June 12, 1992

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Each test site was treated with 500 mg of test material moistened with 1.20 ml of deionized water

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

6: Three males and three females

Details on study design:

TEST SITE
- Area of exposure: 8 x 8 cm
- Type of wrap if used:
Each test site was treated with 500 mg of test material moistened with 1.20 ml of deionized water by introducing the test material beneath a surgical gauze patch measuring 2.5 x 2.5 cm and two single layers thick. Each patch was secured in place with a strip of non-irritating adhesive tape. The entire trunk of each animal was loosely wrapped with a semi-permeable dressing (orthopedic stockinette) to retard evaporation of volatile substances and to prevent possible ingestion of the test material. The wrappings were held in place with non-irritating adhesive tape. The animals were returned to their cages.

REMOVAL OF TEST SUBSTANCE
Four hours after treatment, the wrappmgs and patches were removed. The test sites were gendy wiped with a clean wet cloth to remove as much residual test material as possible.

OBSERVATION TIME POINTS
The test sites were observed for erythema and eschar formation, edema formation, and any other dermal defects or irritation at 3/4, 24, 48 and 72 hours after wiping.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The EPA 81-5 Skin irritation test showed that GU 10-415 should not be classified according to GHS criteria.

Executive summary:

A skin irritation study (EPA 81 -5) was conducted on six albino rabbits using test material GU10-415.

There was one contact skin test site per animal. Each test site was treated with 500 mg of test material moistened with 1.20 ml of deionized water. The test sites were occluded for 4 hours. Observations for dermal irritation and defects were made at 3/4, 24, 48 and 72 hours after the occlusion period.

None of the animals showed signs of skin irritation. No signs of erythema or edema were observed. Therefore, GU10 -415 does not have to be classified according to the GHS criteria.