Boronic acid, (4-ethylphenyl)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2007-03-16 to 2007-07-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2020

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH, Kifilegg
- Age at study initiation: approx. 15 weeks
- Weight at study initiation: The mean initial body weight at the start of the study was 2.88 kg
- Housing: Animals were kept separately in special rabbit cages in an air-conditioned room
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: More than 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-19
- Humidity (%): 45-50
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

VEHICLE
- Amount applied: 0.5 g of the test item was mixed with some drops of Aqua pro injectione before administration.

Duration of treatment / exposure:

4 hours

Observation period:

The rabbits were examined for skin alterations, behavior, and general condition 1 hour after removal of the patches, after 24, 48, 72 hours, and then daily up to experimental day 8.

Number of animals:

3 females

Details on study design:

TEST SITE
- Area of exposure: 6 cm^2
- Type of wrap: Fixomull® stretch, Beiersdorf

REMOVAL OF TEST SUBSTANCE
- Washing: Test material residues were wiped off
- Time after start of exposure: 4 hours after start of exposure

OBSERVATION TIME POINTS
The rabbits were examined for skin alterations, behavior, and general condition 1 hour after removal of the patches, after 24, 48, 72 hours, and then daily up to experimental day 8

SCORING SYSTEM:
- Method of calculation: Skin changes at the application sites were evaluated according to the DRAIZE-, OECD-and EEC recommendations (see table 1).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects

Remarks on result:

no indication of irritation

Other effects:

- Other adverse systemic effects: No signs of clinical toxicity were observed.
- Mortality: All animals survived the observation period.
- Body weight: Body weight development of the treated rabbits was insonspicious.

Any other information on results incl. tables

Table 2: Individual local findings (scores)

     

Animal No.	Finding	Day
		1(1 h)	2 (24 h)	3 (48 h)	4 (72 h)	5	6	7	8
14	Erythema	0	0	0	0	0	0	0	0
	Edema	0	0	0	0	0	0	0	0
15	Erythema	0	0	0	0	0	0	0	0
	Edema	0	0	0	0	0	0	0	0
16	Erythema	0	0	0	0	0	0	0	0
	Edema	0	0	0	0	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No skin irritating potential of the test item could be detected in a primary skin irritation test in rabbits according to OECD guideline 404.

Executive summary:

The test material was mixed with some drops of Aqua pro injectione to ensure good contact with the skin. Afterwards, the test material was spread onto patches and applied to the intact skin of previously shaven rabbits for 4 hours under semi-occlusive conditions. The study was performed initially with one animal and followed by the confirmatory test with two further animals according to OECD guideline 404. The first examination of the treated skin followed 1 hour after patch removal. Thereafter, examinations were performed daily for a further 7 days. Under the conditions of the present study no signs of irritation were seen.