Reaction mass of phenol and tetraphenylphosphonium phenolate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

1987

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

1992

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetraphenylphosphonium phenolate

EC Number:

239-480-3

EC Name:

Tetraphenylphosphonium phenolate

Cas Number:

15464-47-8

Molecular formula:

C24H20P.C6H5O

IUPAC Name:

tetraphenylphosphanium benzenolate

Constituent 2

Reference substance name:

Phenol

EC Number:

203-632-7

EC Name:

Phenol

Cas Number:

108-95-2

Molecular formula:

C6H6O

IUPAC Name:

phenol

Test material form:

solid

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Chr. Fred Leuschner & Co., 24601 Lohndorf/Post Wankendorf, Germany
- Age at study initiation: approx. 6.5 months
- Weight at study initiation: 2.9 - 3.0 kg
- Acclimation period: at least 20 days

IN-LIFE DATES: From: 1998-02-02 To: 1009-02-24

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The untreated eye served as a control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg

Duration of treatment / exposure:

after administering the test item into the conjunctival sac of the right eye of 3 rabbits the lid was then gently held together for about one second in order to prevent loss of the test material

Observation period (in vivo):

up to 21 days post-instillation

Number of animals or in vitro replicates:

3 rabbits

Details on study design:

The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and also 1, 24, 48, 72 hours and 4 to 21 days after the administration. The eye reactions were observed and registered.
24 hours, 7, 14, and 21 days after administration the eyes were treated additionally with fluorescein and examined.
Eyes are monitored until the changes obsered have completely subsided, however for not more than 21 days after application.

SCORING SYSTEM:
Cornea opacity: score range 0-4
Iris: score range 0-2
conjunctivae redness: score 0-3
conjunctivae chemosis: score 0-4
any further lesions are listed.

TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

animal: #1, #2, #3

Time point:

other: up to day 21

Score:

> 4

Max. score:

4

Reversibility:

not reversible

Remarks:

within 21 days

Remarks on result:

probability of severe irritation

Remarks:

in the first 9 days score 1-2, increasing to score 3 at days 10-14 and to score 4 at days 15-19; thereafter the cornea appeared destroyed

Results 2

Irritation parameter:

iris score

Basis:

animal: #1, #2, #3

Time point:

other: up to day 21

Score:

> 2

Max. score:

2

Reversibility:

not reversible

Remarks:

within 21 days

Remarks on result:

probability of severe irritation

Remarks:

in the first 9 days score 1, increasing to score 2 at days 10-19; thereafter the cornea appeared destroyed

Results 3

Irritation parameter:

conjunctivae score

Basis:

animal: #1, #2, #3

Time point:

other: up to day 21

Score:

>= 0 - <= 1

Max. score:

3

Reversibility:

not reversible

Remarks:

within 21 days

Remarks on result:

probability of severe irritation

Remarks:

in the first 3 days score 0; on days 4-19 whitish deposits were seen in the conjunctival sac (probably pus) with temporarily slight reddening; thereafter the cornea appeared destroyed

Results 4

Irritation parameter:

chemosis score

Basis:

animal: #1, #2, #3

Time point:

other: up to day 21

Score:

>= 2

Max. score:

4

Reversibility:

not reversible

Remarks:

within 21 days

Remarks on result:

probability of severe irritation

Remarks:

score 2-3 on days 1-19; thereafter the cornea appeared destroyed

Irritant / corrosive response data:

Severity of eye irritation increasing with time after exposure with maximal scores of 4 for erythema, 2 for iritis, 1 for redness (with whitish deposits in the conjunctival sac, probably pus), and 3 for edema. At day 20 the cornea appeared destroyed and evaluation was not possible any more.

Other effects:

There were no systemic intolerance reactions.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance severely damages the eye of rabbits.

Executive summary:

In an eye irritation study performed according to OECD 405 on three rabbits the severity of eye irritation increased with time after exposure. Maximal scores of 4 for erythema, 2 for iritis, 1 for redness (with whitish deposits in the conjunctival sac, probably pus), and 3 for edema. At day 20 the cornea appeared destroyed and evaluation was not possible any more. The effects showed no reversibility within the observation period of 21 days. The test substance is thus severely damaging the eyes of rabbits.