Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study pre-dates GLP and the standard guidelines; nevertheless, data is well summarised and the experiment is conducted in accordance with generally accepted scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Test conducted in accordance with FHSA principles.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
not specified
Preparation of test site:
other: intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
500 mg applied as a finely ground powder, moistened with water.
Duration of treatment / exposure:
24 hours
Observation period:
7 days
Number of animals:
6
Details on study design:
Local dermal irritation was assessed using the prescribed numerical system:

Erythema and eschar formation:

No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) or eschar formation (injuries in depth) preventing erythema reading 4

Edema formation:

No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well-defined by definite raising) 2
Moderate edema (edges raised approximately 1 millimetre) 3
Severe edema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
score for 6 animals
Time point:
other: Mean score for 24, 48 and 72 hours
Score:
0.9
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Intact and abraded skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
score for 6 rabbits
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.94
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
score for 6 rabbits
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0.94
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
score for 6 rabbits
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
score for 6 animals
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Abraded skin

Any other information on results incl. tables

Table 1 Summary of Results after Exposure

Animal Number

Erythema

Edema

4 hours

24 hours

48 hours

72 hours

7 days

4 hours

24 hours

48 hours

72 hours

7 days

I

A

I

A

I

A

I

A

I

A

I

A

I

A

I

A

I

A

I

A

1

2

3

4

5

6

0

0

0

0

0

0

0

0

0

0

0

0

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

1

0

1

1

1

1

1

0

1

1

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

I = Intact skin

A = Abraded skin

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test material is not classified in accordance with EU criteria.
Executive summary:

The potential of the test material to cause primary skin irritation was assessed in the New Zealand Albino rabbit.

500 mg of the test material was applied as a finely ground powder moistened with water to the intact and abraded skin of 6 test animals, with exposure lasting for 24 hours. The animals were observed for 7 days.

Slight erythema was evident for the 72 hours following exposure. However these effects were completely reversed after 7 days. No edema was seen.

As a result of this, no classification is required in accordance with EU criteria under the conditions of this study.