Sodium 2-biphenylate

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:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

adopted May 1981

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 2-biphenylate

EC Number:

205-055-6

EC Name:

Sodium 2-biphenylate

Cas Number:

132-27-4

Molecular formula:

C12H9NaO

IUPAC Name:

sodium 2-phenylphenolate

Test material form:

solid: particulate/powder

Details on test material:

Batch No.: 80/07319

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd. (breeder)
- Weight at study initiation: 3.0, 3.1 and 3.6 kg, respectively
- Housing: The rabbits were individually housed in single cages (wire cages type III-high). Below the cages excrement trays with low-dust wood granulate type S 8/15 (Ssniff, Soest, Germany) were located.
- Diet: Standard diet "Ssniff K 4" (supplied by Versuchstierdiäten GmbH, Soest, Germany), approximately 100 - 120 g per animal and day
- Water: Tap water, ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): Approximately 50
- Air changes (per hr): Approximately 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 08 Mar 1988 To: 15 Mar 1988

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL

Duration of treatment / exposure:

24 h

Observation period (in vivo):

7 days
Reading time points: 1, 24, 48 and 72 h and 7 days

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye was rinsed with pysiological sodium chloride solution.
- Time after start of exposure: 24 h

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: 1% fluorescein solution and ultraviolet light

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of all 3 rabbits

Time point:

24/48/72 h

Score:

1.67

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days

Results 2

Irritation parameter:

cornea opacity score

Basis:

animal: #1 and #2

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days

Results 3

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days

Results 4

Irritation parameter:

iris score

Basis:

mean

Remarks:

of all 3 rabbits

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

not reversible

Remarks:

within 7 days

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of all 3 rabbits

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

not reversible

Remarks:

within 7 days

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of all 3 rabbits

Time point:

24/48/72 h

Score:

1.78

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

2.3

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days

Results 9

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

not reversible

Remarks:

within 7 days

Irritant / corrosive response data:

Animal #1 and #2 showed a cornea opacity score of 2 at the 1-, 24-, 48- and 72-h reading time point, which increased at the 7-day reading time point (score of 3). Animal #3 showed a cornea opacity score of 1 at all reading time points. The iris score was 1 and the conjunctivae score was 2 for all 3 rabbits at all reading time points. A slight swelling (chemosis score of 1) was determined in rabbit #1 at the 1-h and 7-day reading time point, which enhanced to a distinct swelling (score of 2) at the 24-, 48- and 72-h reading time point. A slight swelling was also observed at the 1-h reading time point in rabbit #2, which resulted in a distinct swelling (score of 2) at the 24- and 48-h reading time point in a score of 3 at the 72-h reading time point. This effect was not reversible within 7 days (score 2). Rabbit #3 showed a chemosis score of 1 at all reading time points.
The mucous membrane of the third eyelid of the animals was necrotized from the first evaluation. At the 7-day reading time point, 1/3 rabbits had a corneal pannus and hair loss at the upper and lower margin of the eyelid, respectively.

Any other information on results incl. tables

Table 1: Summary of Results

Rabbit #	Time [h]	conjunctivae		iris	cornea
		redness	swelling
1	1	2	1	1	2
	24	2	2	1	2
	48	2	2	1	2
	72	2	2	1	2
	average	2,0	2,0	1,0	2,0
2	1	2	1	1	2
	24	2	2	1	2
	48	2	2	1	2
	72	2	3	1	2
	average	2,0	2,3	1,0	2,0
3	1	2	1	1	1
	24	2	1	1	1
	48	2	1	1	1
	72	2	1	1	1
	average	2,0	1,0	1,0	1,0
	Time [h]	conjunctivae		iris	cornea
		redness	swelling
average score	1	2,00	1,00	1,00	1,67
	24	2,00	1,67	1,00	1,67
	48	2,00	1,67	1,00	1,67
	72	2,00	2,00	1,00	1,67
	24+48+72	2,00	1,78	1,00	1,67

Applicant's summary and conclusion

Interpretation of results:

other: Eye Dam. 1, H318 according to Regulation (EC) No. 1272/2008

Conclusions:

CLP: Eye Dam. 1, H318