Registration Dossier

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:
1988-05-9 to 1988-05-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
3 animals (the minimum permitted) were treated
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Patchouli P/578
- Appearance: straw coloured liquid
- Sample No.: S16935T01

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Commerical supplier
- Weight at study initiation: Animal 1: 2.14 kg; Animal 2: 2.37 kg; Animal 3: 2.27 kg
- Housing: Individually caged throughout testing
- Diet: Free access to pelleted food
- Water: Free access

ENVIRONMENTAL CONDITIONS
- After patch application, each animal was immobilised in canvas body sleeve and placed in a quiet place for the 4 hour contact period.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipping
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
4 hours
Observation period:
Observations were made at 30-60 minutes, and then at 24, 48 and 72 hours after patch removal.
Number of animals:
Three
Details on study design:
DESIGN

- No standard substance was applied for corroborative purposes
- The untreated skin of each animal served as its own control
- The degree of irritation was recorded in accordance with criteria given in Table 1 (below)

ANIMALS
- Testing was conducted when the hair was in the telogen (non-growth) phase of the hair cycle.
- Three to four days prior to testing, the dorsal area of the trunk of healthy adult animals was clipped to identify those which were in telogen and which had no skin blemishes.

PATCHES
- Each patch consisted of a 25 mm x 25 mm gauze pad, backed by a 20 mm x 30 mm strip of thin polythene film stuck to a 25 mm x 75 mm strip of zinc oxide sticking plaster.
- Animals were removed from the canvas body sleeves after 4 hours and the corners of each treatment site were marked.
- Patches were then removed and excess substance wiped from the skin with a damp tissue.



Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.67
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.67
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.33
Reversibility:
not fully reversible within: 72 hours
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 72 hours
Irritant / corrosive response data:
One hour after patch removal, two animals showed slight erythema and one showed distinct erythema. Two also showed slight oedema. These effects intensified to show marked erythema, together with slight or marked oedema, in all three animals at 24 to 72 hours after patch removal.

The individual scores are given in Table 2.
Other effects:
No data

Any other information on results incl. tables

Table 2: Results data

Animal number

Erythema

Oedema

1 h

24 h

48 h

72 h

Mean*

1 h

24 h

48 h

72 h

Mean*

1

1

2

2

1

1.67

1

1

1

1

1

2

1

2

2

2

2

0

1

2

2

1.67

3

2

2

2

3

2.33

1

2

2

2

2

* Mean of 24 h, 48 h and 72 h scores

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material was not irritating to rabbit skin.