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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): HDDA
- Analytical purity: no data given

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Buckmasters, Henham, GB
- Age at study initiation: 11-13 weeks
- Weight at study initiation: 2.4 - 2.9 kg
- Housing: individually in metal cages with perforated floors
- Diet: SDS Standard Rabbit Diet, ad libitum
- Water: tap water, ad libitum
- Acclimation period: yes (not further specified)

ENVIRONMENTAL CONDITIONS
- Temperature: 19 °C
- Humidity: 30 - 70 %
- Air changes: approx. 19 per hour
- Photoperiod: 12 hrs dark / 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated sites of the same animal served as control.
Amount / concentration applied:
0.5 ml undiluted test material
Duration of treatment / exposure:
4 hours
Observation period:
14 days
Number of animals:
3 animals
Details on study design:
Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 10 cm square.
A 0.5 ml aliquot of HDDA was applied under a 2.5 cm square gauze pad to one intact skin site on each animal.
Each treatment site was occluded with "Elastoplast" elastic adhesive dressing for a four hour period. The animals were not restrained during the exposure period and were returned to their cages.
At the end of the exposure period, the semi-occlusive dressing and gauze pad were removed and the treatment site was washed using water to remove any residual test substance.

Examination of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4. Additional observations were made on Days 5 through 14.

Grading and scoring of the dermal reactions were performed using the prescribed numerical scoring system according to Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: desquamation was seen on days 9 through 14
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: desquamation was seen on days 9 through 14
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: desquamation was seen on days 9 through 14
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
2.67
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritant / corrosive response data:
The single semi-occlusive application of HDDA to intact rabbit skin for four hours elicited persistent well-defined to moderate dermal irritation.

Any other information on results incl. tables

Table 1: Erythema and edema scores of the individual animals from day 1 to day 14

 

Animal 1

Animal 2

Animal 3

Day

Erythema

Edema

Erythema

Edema

Erythema

Edema

1

2

3

2

3

2

3

2

2

3

2

3

2

3

3

2

2

2

2

2

2

4

2

3

2

2

2

2

5

2

2

2

2

2

2

6

2

2

2

2

2

2

7

2

1

2

1

2

2

8

2

1

2

1

2

2

9

2

2

2

2

2

2

10

2

2

2

2

2

2

11

2

1

2

2

2

2

12

2

1

2

1

2

1

13

1

1

2

1

1

1

14

1

0

1

1

1

1

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Migrated information