Registration Dossier

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:
EPA OTS 798.4500 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Resultsopen allclose all
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
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
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
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.