Isodecyl diphenyl phosphate

Eye irritation

Administrative data

Endpoint:

eye irritation, other

Remarks:

In Vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

July 14, 1980 - July 21, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study similar to OECD Guideline 405. QA. Environmental conditions not reported. Acceptable basic data.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

9 rabbits; exposure time

Principles of method if other than guideline:

Not applicable

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Isodecyl diphenyl phosphate

EC Number:

249-828-6

EC Name:

Isodecyl diphenyl phosphate

Cas Number:

29761-21-5

Molecular formula:

C22H31O4P

IUPAC Name:

isodecyl diphenyl phosphate

Constituent 2

Reference substance name:

180-415 (C9889-147)

IUPAC Name:

180-415 (C9889-147)

Details on test material:

- Name of test material (as cited in study report): 180-415
- Physical state: liquid
- Analytical purity: no data
- Lot/batch No.: no data
- Stability under test conditions: no data
- Storage condition of test material: room temperature

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, USA
- Age at study initiation: young adult
- Weight at study initiation: no data
- Housing: individually, in suspended wire bottom galvanize steel gages
- Diet (e.g. ad libitum): Purina rabbit chow, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: approx. one week

ENVIRONMENTAL CONDITIONS: no data

IN-LIFE DATES: no data

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted (100%)

Duration of treatment / exposure:

6 rabbits: 7 days (unwashed)
3 rabbits: 30 seconds (washed)

Observation period (in vivo):

1, 24, 48, and 72 hours, and at 4 and 7 days after treatment

Number of animals or in vitro replicates:

9 (6 males and 3 females)

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): 3 of the 9 treated rabbits washed with room temperature deionised water for 1 minute
- Time after start of exposure: 30 seconds after treatment

SCORING SYSTEM: Numerical according to guidelines described by Draize (1965) (corneal, iridic and conjunctival irritation (redness/chemosis/discharge)).

TOOL USED TO ASSESS SCORE: fluorescein: observations with fluorescein staining were made at 1 and 24 hours after the application of the test substance and until there was no staining for 3 consecutive observations.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

9 rabbits

Time point:

other: 24, 48,and 72 hours

Score:

ca. 0

Max. score:

0

Remarks on result:

other: washed and unwashed eyes

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

6 rabbits

Time point:

other: 24, 48, and 72 hours

Score:

ca. 0.16

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: unwashes eyes

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

6 rabbits

Time point:

other: 24, 48, and 72 hours

Score:

ca. 0.66

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: unwashed eyes

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

3 rabbits

Time point:

other: 24, 48, and 72 hours

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: washes eyes

Results 5

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

6 rabbits

Time point:

other: 24, 48, and 72 hours

Score:

ca. 0.16

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: unwashed eyeys

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

3 rabbits

Time point:

other: 24, 48, and 72 hours

Score:

ca. 0.33

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: washed eyes

Other effects:

None

Any other information on results incl. tables

Not relevant

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Based on the mean scoring results (all < 1.00) and according to the criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS), 180-415 does not have to be classified and has no obligatory labelling requirement for eye irritation.

Executive summary:

This eye irritation test, comparable to OECD Guideline 405, consists of a single instillation of 0.1.ml of the undiluted test material (180-415) into the conjunctival sac of the left eye of each of 9 rabbits. The treated eye was washed with water 30 seconds after exposure in 3 rabbits and the eyes were left unwashed in the remaining 6 rabbits. The untreated eye of each animal served as a negative control. The cornea, the iris, and conjunctivae were observed at 1, 24, 48, and 72 hours, and at 4 and 7 days after treatment. Observations with fluorescein staining were made at 1 and 24 hours after the application of the test substance and until there was no staining for 3 consecutive observations. The guidelines described by Draize (1965) were used to assign numerical scores to the observed effects and to develop a weighted total score for each animal for each day of observations. Based on the mean scoring results (all < 1.00) and according to the criteria outlined in 67/548/EEC and 1272/2008/EC (CLP/EU-GHS), 180-415 does not have to be classified and has no obligatory labelling requirement for eye irritation.