Bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992-07-27 to 1992-10-19

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-Guideline study (OECD Guideline 405)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adpted on 12 May 1981

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphate

EC Number:

416-140-4

EC Name:

Bis(2,4-di-tert-butyl-6-methylphenyl)ethyl phosphate

Cas Number:

145650-60-8

Molecular formula:

C32H51 O3 P

IUPAC Name:

bis(2,4-di-tert-butyl-6-methylphenyl) ethyl phosphite

Details on test material:

Physical properties: Solid, white

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Chemisch-pharmazeutische Fabrik, D-7950 Biberach/Riss, Germany
- Weight at study initiation: 2340 to 2730g
- Housing: Individually in metal cages
- Diet: Standard rabbit pellet, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature: 20 +/-3°C
- Humidity: 30-70%
- Photoperiod: 12 hrs light cycle

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: the right eye of each animal remained untreated and served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1mL (67 mg) of the test substance

Duration of treatment / exposure:

The eye was not rinsed after application.

Observation period (in vivo):

10 days

Number of animals or in vitro replicates:

3 male rabbits

Details on study design:

SCORING SYSTEM according to OECD 405 (1981):

CORNEA
Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupil barely discernible 3
Opaque cornea, iris not discernible through the opacity 4

IRIS
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive) 1
No reaction to light, hemorrhage, gross destruction (any or all of these) 2

CONJUNCTIVAE
Redness (refers to most severe reading of palpebral and bulbar conjunctivae when compared with control eye)
Blood vessels normal 0
Some blood vessels definitely hyperemic (injected) 1
Diffuse, crimson color, individual vessels not easily discernible 2
Diffuse beefy red 3

CHEMOSIS: lids and/or nictitating membranes
No swelling 0
Any swelling above normal (including nictitating membranes) 1
Obvious swelling with partial eversion of lids 2
Swelling with lids about half-closed 3
Swelling with lids more than half-closed 4


TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

other: 24, 48, 72 hrs

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hrs

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Results 4

Irritation parameter:

iris score

Basis:

animal #1

Time point:

other: 24, 48, 72 hrs

Score:

0.7

Max. score:

2

Reversibility:

fully reversible within: 72 hrs

Results 5

Irritation parameter:

iris score

Basis:

animal #2

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

2

Results 6

Irritation parameter:

iris score

Basis:

animal #3

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

2

Results 7

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #1

Time point:

other: 24, 48, 72 hrs

Score:

1.3

Max. score:

3

Reversibility:

fully reversible within: 10 days

Results 8

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #2

Time point:

other: 24, 48, 72 hrs

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hrs

Results 9

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

animal #3

Time point:

other: 24, 48, 72 hrs

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 48 hrs

Results 10

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

other: 24, 48, 72 hrs

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 48 hrs

Results 11

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Results 12

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

other: 24, 48, 72 hrs

Score:

0

Max. score:

4

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information