Gum benzoin, Siam

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 May 1988 to 24 May 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

1

Reference substance name:

Gum benzoin, Siam

EC Number:

232-556-7

EC Name:

Gum benzoin, Siam

Cas Number:

9000-72-0

IUPAC Name:

Gum benzoin, Siam

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: commercial supplier
- Age: adults
- Diet: ad libitum
- Water: ad libitum
- housing: caged individually

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: undiluted

Duration of treatment / exposure:

4 hours

Observation period:

24,48, and 72 hours after exposure

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Dorsum
- Type of wrap if used: 25mm x 25mm gauze pad, backed by a 20mm x 30mm strip of thin polythene film stuck to a 25mm x 75 mm strip of zinc oxide sticking plaster.

REMOVAL OF TEST SUBSTANCE
- Washing: excess substance was wiped from the test site with a damp tissue.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
one hour after removal of the test patch thereafter at 24, 48, and 72 hours.

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no edema observed

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 edema observed

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: no edema observed

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

1 hour after patch removal

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

1 hour after patch removal

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 6

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

1 hour after patch removal

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Irritant / corrosive response data:

One hour after patch removal, all three animals showed slight erythema, without oedema. These effects reduced in intensity and all three animals appeared normal at 72 hours after patch removal.

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Remarks:

in accordance with EU CLP (EC 1272/2008 and its updates)

Conclusions:

Benzoin Hypersoluble showed very slight irritancy to rabbit skin. These very slight effects were reversible within 72 hours. Under the conditions of the test, the test substance is not considered to be a skin irritant.

Executive summary:

In a study equivalent to OECD TG 404 the irritating potential of the test substance was investigated. 3 New Zeeland white rabbits were exposed to 0.5mL undiluted test substance for 4 hours under semiocclusive conditions. Observations were made one hour after removal of the test patch thereafter at 24, 48, and 72 hours. Irritation was scored according to the Draize method. One hour after patch removal, all three animals showed slight erythema, without oedema. These effects reduced in intensity and all three animals appeared normal at 72 hours after patch removal. Under the conditions of the test, the test substance is not considered to be a skin irritant.