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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:
Not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted standards with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: FDA Standards
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Bourgeonal
- Substance type: clear colourless liquid
- Physical state: Liquid
- Lot/batch No.: 148983

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
New Zealand White rabbits were supplied by an accredited supplier.

- Age at study initiation:
Adult

- Weight at study initiation:
At the start of the study the animals were in the weight range of 2.5 - 3.0 kg

- Housing:
Not specified in the report

- Diet (e.g. ad libitum):
Not specified in the report

- Water (e.g. ad libitum):
Not specified in the report

- Acclimation period:
Not specified in the report

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
Not specified in the report

- Humidity (%):
Not specified in the report

- Air changes (per hr):
Not specified in the report

- Photoperiod (hrs dark / hrs light):
Not specified in the report

Test system

Type of coverage:
open
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Remarks:
undiluted bourgeonal
Controls:
yes
Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
0.2 ml

- Concentration (if solution):
Not applicable.

VEHICLE
- Amount(s) applied (volume or weight with unit):
Not applicable

- Concentration (if solution):
Not applicable.

- Lot/batch no. (if required):
Notapplicable
Duration of treatment / exposure:
72 hours
Observation period:

72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure:
On the day of the test a suitable test site was selected on the back of each rabbit.

- % coverage:
Not given in study report.

- Type of wrap if used:
Test material was brought into contact with separated skin areas left of the midline of the back.

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Not reported

- Time after start of exposure:
72 hours.


SCORING SYSTEM:
The resulting skin reactions were evaluated by the method of Draize (J. Pharm. Exptl. Therap. 82 (1944) 377-390) 24, 48, 72 and 96 hours after application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: erythema/edema
Basis:
animal: 8803
Time point:
other: Mean score at 24 and 72 hours
Score:
2
Max. score:
8
Reversibility:
no data
Irritation parameter:
other: erythema/Edema
Basis:
animal: 8804
Time point:
other: Mean at 24 and 72 hours
Score:
3
Max. score:
8
Reversibility:
no data
Irritation parameter:
other: Erythema/Edema
Basis:
animal: 8805
Time point:
other: mean at 24 and 72 hours
Score:
3
Max. score:
8
Reversibility:
no data
Irritation parameter:
other: erythema/edema
Basis:
animal: 8806
Time point:
other: mean of 24 and 72 hours
Score:
2
Max. score:
8
Reversibility:
no data
Irritation parameter:
other: erythema/edema
Basis:
animal: 8807
Time point:
other: mean at 24 and 72 hours
Score:
3
Max. score:
8
Reversibility:
no data
Irritation parameter:
other: erythema/edema
Basis:
animal: 8808
Time point:
other: Mean at 24 and 72 hours
Score:
3
Max. score:
8
Reversibility:
no data
Irritant / corrosive response data:
Individual and average skin irritation scores are given in table 1. Bourgeonal caused severe skin irritation. Its dermal effects generally consisted of focal haemorrhages, slight to distinct ischemia and incrustation, and very slight edema.
Other effects:
None

Any other information on results incl. tables

TABLE 1 - INDIVIDUAL AND AVERAGE SKIN IRRITATION SCORES OF BOURGEONAL

Rabbit

Number

Intact Skin

Rabbit

Number

Abraded Skin

24 hours

72 hours

24 hours

72 hours

A                         B

 

A                        B

 

8803

4          -            1

2

8797

4          -            1

2

8804

4          -            1

3

8798

4          -            1

2

8805

4          -            1

3

8799

4          -            1

3

8806

4          -            1

2

8800

4          -            1

3

8807

4          -            1

3

8801

4          -            1

2

8808

4          -            1

3

8802

4          -            1

2

Average

5.0

2.7

Average

5.0

2.3

A = erythema

B = edema

The resulting skin reactions were evaluated by the method of Draize (J. Pharm. Exptl. Therap. 82 (1944) 377-390) 24, 48, 72 and 96 hours after application.


Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the present results it can be concluded that undiluted Bourgeonal is a severe primary skin irritant.
Executive summary:

The product bourgeonal was examined in primary skin irritation using New Zealand White albino rabbits as the experimental animals.

Pure and undiluted bourgeonal caused severe skin irritation.