Biphenyl-4-ol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Non-GLP study, pre-dates OECD guielines and some limitations in reporting but otherwise adequate for assessment.

Justification for data waiving:

other:

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)

Version / remarks:

Based on: Code of Federal Regulations, Title 16, Section 1500.42

Deviations:

no

Remarks:

6 rabbit study

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

p-Phenylphenol

IUPAC Name:

p-Phenylphenol

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Substance: p-Phenylphenol

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: W. Ostrop / Meerbusch (Breeder)
- Weight at study initiation: average weight of 2.8 kg
- Housing: The animals were housed individually in cages
- Diet (e.g. ad libitum): provided with “Mümmel Z” feed (ssniff / Soest) ad libitum
- Water (e.g. ad libitum): water ad libitum

ENVIRONMENTAL CONDITIONS (Rearing conditions)
- Temperature (°C): 16 - 18
- Humidity (%): 40 (relative humidity)
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle

- Other:
- Male rabbits used
- Habituation period 7- 14 d.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: The animal’s left eye remained untreated as a control.

Amount / concentration applied:

single application of 100 µl bulk volume

Duration of treatment / exposure:

8 d (the eye was not rinsed after the application)

Observation period (in vivo):

8 d

Number of animals or in vitro replicates:

6

Details on study design:

Test execution: The test was performed on 6 pre-screened rabbits with an average weight of 2.8 kg by a single application of 100 µl bulk volume of the polymorphous substance in the conjunctival sack of each animal’s lower right eyelid. The lids were then gently held together for 1 sec. The eye was not rinsed after the application. The animal’s left eye remained untreated as a control.

The eyes were then examined with the aid of an ophthalmoscope.

The corneal result was verified after 8 d by the fluorescein test. (Instillation of one drop of fluorescein ophthalmic solution directly onto the cornea. After rinsing with physiological saline solution, corneal damage appears as a yellow-green area. UV light and cobalt blue filter)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0.17

Max. score:

3

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 hours

Score:

0

Max. score:

4

Any other information on results incl. tables

- Findings were recorded 24, 48 and 72 h and 8 days after the start of the test. The control findings after 8 d are not included in the appraisal for the irritation index.

- See the attached report for the results of mucous membrane irritation in rabbits.

- Primary irritation index: 12/18 = 0.7

- Classification: non-irritant

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The product is thus classified as a non irritant to the eye.

Executive summary:

The aforementioned product yielded a primary irritation index of 0.7 in the primary mucous membrane irritation study conducted in accordance with Code of Federal Regulations, Title 16, Section 1500.42.

 

The product is thus classified as a non-irritant to the eye.