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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:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, test procedure in accordance with OECD 406 methods, meets generally accepted scientific principles, acceptable for assessment. Not GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: "Hazardous Substances Regulations" - US Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)
Deviations:
no
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate
EC Number:
222-111-5
EC Name:
Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate
Cas Number:
3351-05-1
Molecular formula:
C32H23N5O6S2.2Na
IUPAC Name:
NA
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
The rabbits were caged singly in an experimental room maintained at a temperature of 20°C. (± 1°) and a relative humidityof 50-70%. Animals were exposed to artificial light for 10 hours daily from 08.00 - 18.00 hours. A commercial irradiated diet (Styles-Oxoid) was fed ad lib. Sterile filtered water was available at all times.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: shaved and abraded
Vehicle:
water
Controls:
other: intact skin was used as control
Amount / concentration applied:
Test solution: 10 g of the test compound in 10 ml of water0.75 ml of the test solution was applied to each test site on a 2.5 square cm gauze pad.
Duration of treatment / exposure:
24 h
Observation period:
up to 14 days
Number of animals:
6 (3 males; 3 females)
Details on study design:
Twenty-four hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10% ofthe total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before theapplication of the test compound, the right hand site was abraded uith the point of a sterile hypodermic needle. The abrasions weresufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact.10g. of the test compound was mixed with 10 ml of water to make solution of 15 ml., 0.75 ml of which was applied to each testsite on a 2.5 cm. square gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then covered by a 6" wide "Cohan" self adhesive bandage in order to retain the test substance in close contace with the skin.After 24 hours the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema.A further assessment was made at 72 hours and for any further period considered necessary up to 14 days.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
Intact
Basis:
mean
Time point:
other: 24h
Score:
ca. 1.17
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
erythema score
Remarks:
Abraded
Basis:
mean
Time point:
other: 24 h
Score:
ca. 1.5
Reversibility:
other: 3 fully reversible within 72 hours
Irritation parameter:
edema score
Remarks:
Intact
Basis:
mean
Time point:
other: 24 h
Score:
ca. 2.67
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
edema score
Remarks:
Abraded
Basis:
mean
Time point:
other: 24
Score:
ca. 3
Reversibility:
other: 4 fully reversible within 72 hours
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Time point:
24/48/72 h
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 2.29.

Any other information on results incl. tables

Erythema formation

No/sex

Intact

Abraded

24 hours

72 hours

24 hours

72 hours

11 male

1

0

1

0

13

1

0

2

0

15

1

0

2

1

12 female

2

0

2

0

14

1

0

1

1

16

1

0

1

0

Mean

1.17

0

1.5

0.33

Edema Formation

No/sex

Intact

Abraded

24 hours

72 hours

24 hours

72 hours

11 male

3

0

3

0

13

3

0

3

0

15

2

0

3

2

12 female

3

0

3

0

14

3

0

3

1

16

2

0

3

0

Mean

2.67

0

3

0.5

Total: 9.17

Primary irritation index: 2.29

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
non-irritant to the skin
Executive summary:

The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 1.17 for Erythema and 2.67 for Edema based on US Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).

Therefore the tested item is to be considered as non-irritant to the skin of rabbits.