Boronic acid, (4-ethylphenyl)-

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-04-12 to 2008-02-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(4-ethylphenyl)boronic acid

EC Number:

613-145-5

Cas Number:

63139-21-9

Molecular formula:

C8 H11 B O2

IUPAC Name:

(4-ethylphenyl)boronic acid

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: Charles River Wiga GmbH, Kißlegg
- Age at study initiation: Approx. 17 and 47 weeks
- Weight at study initiation: 3.79 kg
- Housing: Separately in a special rabbit cage (manufacturer: Becker; type K.99/30 KU) placed on mobile racks.
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: More than 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15 to 18
- Humidity (%): 42 to 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: Day 0 To: Day 14

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 g of the test material

Duration of treatment / exposure:

14 days

Observation period (in vivo):

Day 0 to day 14

Number of animals or in vitro replicates:

2 females

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: The test substance remained in the eyes of the rabbits up to the end of the observation period.

SCORING SYSTEM: See table 1 in section "Any other information on materials and methods incl. tables".

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: discharge

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.66

Max. score:

3

Reversibility:

fully reversible within: 5 days

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

other: discharge

Basis:

animal #1

Time point:

24/48/72 h

Score:

2.33

Max. score:

3

Reversibility:

fully reversible within: 5 days

Remarks on result:

positive indication of irritation

Results 3

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 6 days

Remarks on result:

positive indication of irritation

Results 5

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 8 days

Remarks on result:

positive indication of irritation

Results 6

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Results 7

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 5 days

Remarks on result:

positive indication of irritation

Results 8

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 5 days

Remarks on result:

positive indication of irritation

Results 9

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

positive indication of irritation

Results 10

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 6 days

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

The cornea developed diffuse areas of opacity (scores 1 and 2) from the first investigation up to day 5 and 7 of the experimental part. At the iris signs of irritation were observed (score 1) from day 2 up to day 5 in one animal. The conjunctivae showed redness (scores 1 and 2) from the first investigation up to day 6 and 7. Chemosis (score 1 and 2) was seen up to experimental day 4. Furthermore, discharge was observed 1 hour after instillation of the test material up to day 4 of the experimental part (scores 1 and 4). The untreated eye was unchanged.

Other effects:

- Lesions and clinical observations: No signs of pain were observed immediately after instillation.

Any other information on results incl. tables

Table 1: Body weights

 

Animal No.	Body weight in kg on experimental day					Body weight gain
	1	5	8	11	15	dayl to 15
18	3.40	3.36	3.42	3.46	3.48	+ 0.08
16	4.18	4.21	4.25	4.25	4.23	+ 0.05
Mean	3.79	3.79	3.84	3.86	3.86	+ 0.07

 

Table 2: Eye alterations, mean score 24, 48 and 72 hours oft wo rabbits

	Mean score (24, 48 and 72 hours)		Maximum value (24, 48 and 72 hours)
Animal No	1	2	1	2
Cornea	1.33	1	2	1
Iris	1	0	1	0
Conjunctivae	1	2	1	2
Chemosis	1	1.33	1	2

 

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritating to eyes) based on GHS criteria

Conclusions:

In this in vivo eye irritation study according to OECD guideline 405, the test item showed eye irritating effects and is thus categorized as irritating to the eye “UN GHS Category 2”.

Executive summary:

The test item was tested for its eye irritating properties. Prior to testing, the hen's egg test on the chorioallantoic membrane was performed and no irritating potential could be detected. The test for primary eye irritation was performed initially with one animal and followed by the confirmatory test with one further animal according to OECD guideline 405. For the test of primary eye irritation, the test material was applied into the conjunctival sac of rabbits. The first examination of the eyes followed 1 hour after instillation. The other examinations of the eyes were performed daily for a further 14 days. Two rabbits were used in this study. No signs of pain were observed immediately after instillation. Diffuse areas of opacity were seen at the cornea 1 hour after instillation up to day 5 and 7 of the experimental part. The iris showed signs of irritation from day 2 up to day 5 in one animal. The conjunctivae were reddened from the first investigation up to day 6 and 7. Chemosis was observed in both animals up to experimental day 4. The individual scores after 24/48/72 hours were 0 (animal 1) and 2 (animal 2) for iris irritation, 2 (animal 1) and 1 (animal 2) for reddening of the conjunctivae, 1.33 (animal 1) and 1 (animal 2) for chemosis and 1 (animal 1) and 1.33 (animal 2) for corneal opacity. The untreated eyes were unchanged. In conclusion, the test item was considered to be irritating to the eye.