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

Eye irritation

Administrative data

Endpoint:

eye 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 81-4 (Acute Eye 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 / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues 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 8, 1992 To: June 11, 1992

Test system

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A dose of 0.1 ml by volume (40.8mg) of the test material

Duration of treatment / exposure:

1 second

Observation period (in vivo):

3 days

Number of animals or in vitro replicates:

Three males and three females (nonwash);
Three males (wash)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Three of the treated eyes ("washed eyes") were each washed with room temperature deionized water for one minute begmning 30 seconds after treatment.
- Time after start of exposure: 30 seconds

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: mean 3 male and 3 female animals, non-washed eyes

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

cornea opacity score

Basis:

other: mean 3 male animals, washed eyes

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 3

Irritation parameter:

iris score

Basis:

other: mean 3 male and 3 female animals, non-washed eyes

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 4

Irritation parameter:

iris score

Basis:

other: mean 3 male, washed eyes

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 5

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

other: mean 3 male and 3 female animals, non-washed eyes

Time point:

24/48/72 h

Score:

0.5

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

other: mean 3 male animals, washed eyes

Time point:

24/48/72 h

Score:

0.22

Max. score:

2

Reversibility:

fully reversible within: 48 hours

Results 7

Irritation parameter:

chemosis score

Basis:

other: mean 3 male and 3 female animals, non-washed eyes

Time point:

24/48/72 h

Score:

0.11

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Results 8

Irritation parameter:

chemosis score

Basis:

other: mean 3 male animals, washed eyes

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 hours

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Following the EPA 81-4 eye irritation study in nine albino rabbits, GU10-415 should not be classified according to GHS criteria.

Executive summary:

An eye irritation study was conducted on nine albino rabbits using test material GU10-415.

The imdiluted test material, 0.1 ml by volume (40.8 mg), was placed into the conjunctival sac of the right eye of each animal selected for testing. Three of the treated eyes ("washed eyes") were each washed with room temperature deionized water for one minute beginning 30 seconds after treatment. All treated eyes were washed with room temperature deionized water for one minute immediately after recording each 24 hour observation.

Effects on animals were very limited: the highest score was a cunjuctivae (redness) score of 2 in one animal (male, washed eyes) which disappeared after 24 hours. If any effects these had all disappeared after 72 hours. Therefore, GU10 -415 should not be classified according to GHS criteria.