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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
not specified

Test material

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

Resultsopen allclose all
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
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
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
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
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
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.

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