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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:
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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.