3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8 February 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study in accordance with internationally recognised guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

EC Number:

410-290-4

EC Name:

3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Cas Number:

80693-00-1

Molecular formula:

Hill formula: C35H54O6P2 CAS formula: C35H54O6P2

IUPAC Name:

3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): PEP-36
- Physical state: White powder
- Purity: assumed to be 100%*
- Lot/batch No.: not reported*
- Date received: 18 February 1988
- Storage condition of test material: At room temperature in the dark

* sample confirmed as representative of manufactured material

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: not reported
- Age at study initiation: young adult
- Weight at study initiation:
- Housing: screen bottomed hanging cages
- Diet (e.g. ad libitum): 120 g per day high fiber rabbit diet
- Water: ad libitum
- Acclimation period: 7 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): temperature controlled but value/range not reported
- Humidity (%): humidity controlled but value/range not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hours dark

IN-LIFE DATES: From: 17 March To: 24 March 1988

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 ml (25mg)

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE:
-Washing: no

SCORING SYSTEM:
-Draize scale for scoring ocular lesions

TOOL USED TO ASSESS SCORE:
-Fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

other: 24, 48 and 72 hrs

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 72 hrs

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hrs

Score:

0.16

Max. score:

1

Reversibility:

fully reversible within: 72 hrs

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hrs

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 72 hrs

Results 4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hrs

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 72 hrs

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 3 days

Any other information on results incl. tables

Animal	Sex	Observation period	Cornea opacity	Iris	Redness	Chemosis
1	M	1 hour 24 hours 48 hours 72 hours	0 0 0 0	0 0 0 0	1 0 0 0	0 0 0 0
2	M	1 hour 24 hours 48 hours 72 hours	0 0 0 0	0 0 0 0	1 1 0 0	1 0 0 0
3	F	1 hour 24 hours 48 hours 72 hours	0 0 0 0	0 0 0 0	1 0 0 0	0 0 0 0
4	M	1 hour 24 hours 48 hours 72 hours	0 0 0 0	0 0 0 0	1 1 0 0	1 0 1 0
5	F	1 hour 24 hours 48 hours 72 hours	0 0 0 0	0 0 0 0	1 0 0 0	0 0 0 0
6	F	1 hour 24 hours 48 hours 72 hours	0 0 0 0	0 0 0 0	1 0 0 0	0 0 0 0

Not classified i.e.:

The substance did not, when applied to the eye of an animal, produce:

At least in 2 of 3 tested animals, a positive response of:

— corneal opacity ≥ 1 and/or

— iritis ≥ 1, and/or

— conjunctival redness ≥ 2 and/or

— conjunctival oedema (chemosis) ≥ 2

Calculated as the mean scores following grading at 24, 48 and 72 hours after installation of the test material, and which fully reverses within an observation period of 21 days.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Based upon the results of this study, 3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane is considered to be mildly irritating to rabbit eyes.