Disodium 3-[(5-chloro-2-phenoxyphenyl)azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From June 32 to July 25, 1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: method given in the "Hazardous Substances Regulations" under the U.S. Federal Hazardous . Substances Labelling Act Sect. 191.11 (February 1965).

GLP compliance:

no

Remarks:

Pre GLP.

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 3-[(5-chloro-2-phenoxyphenyl)azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate

EC Number:

229-129-2

EC Name:

Disodium 3-[(5-chloro-2-phenoxyphenyl)azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate

Cas Number:

6416-66-6

Molecular formula:

C29H20ClN3O10S3.2Na

IUPAC Name:

Disodium 3-[(5-chloro-2-phenoxyphenyl)azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Number of animals: 6 (3 male; 3 female)- Age at study initiation: 9 -14 weeks- Weight at study initiation: 2.15 (male); 2.75 (female)- Housing: singly caged- Diet : commercial irradiated diet (Syles Oxoid), ad libitum- Water : ad libitum for all test durationENVIRONMENTAL CONDITIONS- Temperature (°C): 21°C ± 2°- Relative humidity: 50-70 %- Photoperiod (hrs dark / hrs light): 10 hours of light (8:00-18:00)

Test system

Type of coverage:

occlusive

Preparation of test site:

abraded

Vehicle:

water

Controls:

other: non abraded part of the skin area considered

Amount / concentration applied:

10g. of the test compound was mixed with 10ml of water to make a solution of 15ml. 0.75ml of which was applied to each test site on a 2.5 cm square gauze pad.

Number of animals:

6 (3 male and 3 female)

Details on study design:

TEST SITE24 hours prior to the dermal application, the backs of the rabbits were shaved over an area consisting of at least 10 %of the total body surface. Two test sites lateral to the mid line of the back were used on each rabbit. Immediately before the application of the test compound, the right hand site was abraded with 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 sits remained intact.These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6 " wide "Coban" self adhesive bandage the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.REMOVAL OF TEST SUBSTANCEAfter 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.SCORE SYSTEMThe assessment of the macroscopic skin reaction was made according to the Draize et al. 3. Pharmac. Exp. Ther. 82 377 1944.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

48th hour data is not available. The value of the 24th hour was taken to be more conservative. See attached table of results.

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

48th hour data is not available. The value of the 24th hour was taken to be more conservative. See attached table of results.

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

48th hour data is not available. The value of the 24th hour was taken to be more conservative. See attached table of results.

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

48th hour data is not available. The value of the 24th hour was taken to be more conservative. See attached table of results.

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

48th hour data is not available. The value of the 24th hour was taken to be more conservative. See attached table of results.

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

4

Remarks on result:

no indication of irritation

Remarks:

48th hour data is not available. The value of the 24th hour was taken to be more conservative. See attached table of results.

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1.33

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: 48th hour data is not available. The value of the 24th hour was taken to be more conservative. See attached table of results.

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 1.33

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: 48th hour data is not available. The value of the 24th hour was taken to be more conservative. See attached table of results.

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 1.33

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: 48th hour data is not available. The value of the 24th hour was taken to be more conservative. See attached table of results.

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Time point:

24/48/72 h

Score:

ca. 1.33

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: 48th hour data is not available. The value of the 24th hour was taken to be more conservative. See attached table of results.

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Time point:

24/48/72 h

Score:

ca. 1.33

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: 48th hour data is not available. The value of the 24th hour was taken to be more conservative. See attached table of results.

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

24/48/72 h

Score:

ca. 1.33

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: 48th hour data is not available. The value of the 24th hour was taken to be more conservative. See attached table of results.

Irritant / corrosive response data:

Slight erythema was seen on 2/6 abraded sites and slight to moderate oedema was seen on all sites, 24 hours after application of the compound. All sites were normal by 72 hours.See table for further details.

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Not skin irritant

Executive summary:

The determination of skin irritation was determined in an a Primary Skin Irritation test. No guideline is available and the test was not performed in GLP. The test substance was tested in albino rats for 72 h. Erythema and oedema formation were observed.

No erythema was observed on intact skin. Slight erythema was seen on 2/6 abraded sites and slight to moderate oedema was seen on all sites, 24 hours after application of the compound. All sites were normal by 72 hours. The primary irritation score was 1.2