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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:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study follows acceptable practices. Conducted prior to GLP regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Guidelines established by the US Federal Hazardous Substances Act (1973)
Deviations:
not specified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: viscous, applied as 50% in light paraffinic petroleum oil as placed on the market
Details on test material:
50% DNNSA (DI C8-C10, BRANCHED, C9 RICH, ALKYLNAPHTHALENE SULFONIC ACID)
50% light paraffinic petroleum oil

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Six healthy mature male albino rabbits of the New Zealand variety were selected from the stock colony.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: 6 sites abraded and 6 sites intact skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml of 50% solution in light paraffinic petroleum oil
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 hours
Number of animals:
6
Details on study design:
Prior to application of the sample, the backs were
clipped free of hair. The skin was left intact at six test sites and was
abraded on the other six. 0.5 ml of a liquid test material was
applied to an area of skin approximately 1 inch square on each rabbit. Patches
of surgical gauze measuring 1 inch square, 2 single layers thick, were applied
over the samples and covered with a non-reactive tape. The rabbits were then
wrapped with a rubber dam.
After the 24-hour exposure, the dam and tape were removed and the skin reactions
evaluated. An evaluation was also made at 72 hours after application.
The reactions were scored according to the methods described in the Federal
Hazardous Substances Act.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
no data
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
no data
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24 h
Score:
1.67
Max. score:
4
Reversibility:
no data
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24 h
Score:
1.83
Max. score:
4
Reversibility:
no data
Remarks on result:
other: abraded skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 72 h
Score:
2.16
Max. score:
4
Reversibility:
no data
Remarks on result:
other: intact skin
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 72 h
Score:
2.16
Max. score:
4
Reversibility:
no data
Remarks on result:
other: abraded skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 72 h
Score:
2.16
Max. score:
4
Reversibility:
no data
Remarks on result:
other: intact skin
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 72 h
Score:
2.16
Max. score:
4
Reversibility:
no data
Remarks on result:
other: abraded skin
Irritant / corrosive response data:
The primary irritation index was 4.04, moderate irritation. It would not be considered a primary skin irritant.

INDEX Evaluation
0 No irritation
0.04 to 0.99 Irritation barely perceptible
1.00 to 1.99 Slight irritation
2.00 to 2.99 Mi ld irritation
3.00 to 5.99 Moderate irritation
6.00 to 8.00 Severe irritation

Any other information on results incl. tables

 

RABBIT

NO.

 

24 HOURS

 

72 HOURS

 

INTACT

 

ABRADED

 

INTACT

 

ABRADED

 

ERYTHEMA

 

EDEMA

 

ERYTHEMA

 

EDEMA

 

ERYTHENA

 

EDEMA

 

ERYTHEMA

 

EDEMA

 

A

 

B

 

C

 

D

 

E

 

F

 

G

 

H

 

2582

 

1

 

2

 

1

 

2

 

2

 

2

 

2

 

2

 

2583

 

2

 

2

 

2

 

2

 

2

 

2

 

2

 

2

 

2584

 

1

 2

 

2

 

2

 

1

 

2

 

1

 

2

 

2585

 

2

 

2

 

2

 

2

 

3

 

3

 

3

 

3

 

2586

 

2

 

2

 

2

 

2

 

2

 

2

 

2

 

2

 

2587

 

2

 

2

 

2

 

2

 

3

 

2

 

3

 

2

 

TOTAL

 

10

 

12

 

11

 

12

 

      13

 

13

 

13

 

13

PRIMARY IRRITATION INDEX = ( sum of individual totals, each divided by 6 ) divided by 4 = 4.04

Scoring of Irritation

Evaluation of Skin Reaction

 

Erythema and eschar formation:

Value

No erythema

0

Very slight erythema (barely perceptible)

1

Well-defined erythema

2

Moderate to severe erythema

3

Severe erythema (beet redness) to slight eschar formation (injuries in depth)

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 (raised approximately 1 mm)

3

 

 

Severe edema (raised more than 1 mm) and extending beyond the area of exposure

4

                                                            

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance is a moderate skin irritant but according to classification criteria as defined in GHS and CLP not subject to classification.
Executive summary:

A 50% DNNSA formulation in light paraffinic petroleum oil was tested on six healthy mature male albino rabbits (New Zealand variety) for evaluation of primary irritation. Prior to application of the sample, the backs were clipped free of hair. The skin was left intact at six test sites and was abraded on the other six. 0.5 ml of a liquid test material was applied to an area of skin approximately 1 inch square on each rabbit. Patches of surgical gauze measuring 1 inch square, 2 single layers thick, were applied over the samples and covered with a non-reactive tape. The rabbits were then wrapped with a rubber dam. After the 24-hour exposure, the dam and tape were removed and the skin reactions evaluated. An evaluation was also made at 72 hours after application. The reactions were scored according to the methods described in the Federal Hazardous Substances Act.

RESULTS

The primary irritation index was 4.04 indicating moderate irritation.