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-bis(1,1-dimethylethyl)-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane

IUPAC Name:

3,9-bis(2,6-bis(1,1-dimethylethyl)-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:

Nature of substance: Solide

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

.1 ML

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Score:

0.11

Max. score:

1

Remarks on result:

other: Max. duration: 24 h; Max. value at end of observation period: 0

Results 2

Irritation parameter:

chemosis score

Basis:

mean

Score:

0.08

Max. score:

1

Remarks on result:

other: Max. duration: 48 h; Max. value at end of observation period: 0

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Score:

0

Max. score:

0

Remarks on result:

other: Max. duration: h; Max. value at end of observation period: 0

Results 4

Irritation parameter:

iris score

Basis:

mean

Score:

0

Max. score:

0

Remarks on result:

other: Max. duration: h; Max. value at end of observation period: 0

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, Phosphorous acid, cyclic neopentanetetrayl bis (2,6-di-tert-butyl-4-methylphenyl) ester is considered to be mildly irritating to rabbit eyes.