Resinoid of Canarium luzonicum (Burseraceae) obtained from the exudate by benzyl benzoate extraction

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4 December 1984 - 14 January 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

the grading scale is different from the OECD guideline (Draize); 3-day observation period; the same animals are tested with different test items

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Resinoid of Canarium luzonicum (Burseraceae) obtained from the exudate by benzyl benzoate extraction.

Molecular formula:

Not applicable (UVCB)

IUPAC Name:

Resinoid of Canarium luzonicum (Burseraceae) obtained from the exudate by benzyl benzoate extraction.

Specific details on test material used for the study:

Extract of elemi gum with benzyl benzoate, containing 30% benzyl benzoate
Name of test material: Elemi resinoid P
Appearance: thick pale yellow jelly
Storage: ambiant temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: commercial supplier
- Age at study initiation: 9-12 weeks
- Weight at study initiation: 1.62-2.34 kg
- Housing: individually in suspended cages with wire mesh floor
- Diet (e.g. ad libitum): pelleted, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 3-4 days

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

3 or 4 days prior to testing the backs and flanks of rabbits are clipped. The hair is given a final clip about 2h prior to treatment

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

7

Details on study design:

Each patch consists of a 25x25 mm, 16-ply gauze pad backed by a 20x30 mm strips of thin polythene and stuck to a 25x75 mm strip of zinc oxide plaster.
Up to 6 patch tests are applied on each animal
Rabbits are immobilised in a canvas body sleeve and placed in a quiet place for the 4-h application period, at the end of which the animals are removed from the body sleeves and the corners of each treatment site marked. Patches are then removed and excess substance wiped from the skin with a damp tissue.

Assessment:
Treatment sites are assessed immediately after removal of the patches and 24, 48 and 72 h after treatment.

Reactions are assessed for erythema, edema, cracking and scaling on a 9-point scale ranging from slight (a) to severe (h). Any other features of responses are described and recorded.

-: no reaction
a: marginal (very slight)
b: slight
c: fairly distinct
d: quite distinct
e: becoming well developped
f: well developped
g: becoming severe
h: severe

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

other: all animals

Time point:

24/48/72 h

Reversibility:

other: reversible

Remarks on result:

probability of weak irritation

Other effects:

No signs of cracking or scaling were observed.

Any other information on results incl. tables

Table 1: Individual scores

Rabbit No	4 hours		24 hours		48 hours		72 hours
	Erythema	Edema	Erythema	Edema	Erythema	Edema	Erythema	Edema
1	-	-	b	a	b	a	-	-
2	b	a	b	a	-	-	a	-
3	b	a	b	a	a	-	a	a
4	b	a	a	-	a	-	-	-
5	-	-	-	-	-	-	-	-
6	b	a	-	-	a	-	-	-
7	a	a	-	-	a	-	-	-

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the experimental conditions, only reversible slight signs of edema and erythema, equivalent to maximum score 1 in Draize grading scale, were observed therefore the substance can be considered as slightly irritant and does not require classification according to Regulation EC N° 1272/2008 (CLP) criteria.

Executive summary:

7 New Zealand White rabbits were applied 0.5 mL of undiluted test item for 4 hours under semi-occlusive conditions. Reactions were recorded immediately, 24, 48 and 72 h after treatment.

Under the experimental conditions, partly reversible slight signs of edema and erythema, equivalent to maximum score 1 in Draize grading scale, were observed therefore the substance can be considered as slightly irritant and does not require classification according to Regulation EC N° 1272/2008 (CLP) criteria.