4-anilino-3-nitro-N-phenylbenzenesulphonamide

Epidemiological data

Administrative data

Endpoint:

epidemiological data

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was not conducted according to OECD guideline and GLP but the report contains sufficient data to permit interpretation of study results

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Study type:

other: Repeated Insult Patch Test

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Not available

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

4-anilino-3-nitro-N-phenylbenzenesulphonamide

EC Number:

225-862-7

EC Name:

4-anilino-3-nitro-N-phenylbenzenesulphonamide

Cas Number:

5124-25-4

Molecular formula:

C18H15N3O4S

IUPAC Name:

4-anilino-3-nitro-N-phenylbenzenesulfonamide

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): Disperse Yellow 042

Method

Type of population:

general

Ethical approval:

not specified

Details on study design:

Two hundred individuals were employed to participate in this evaluation. Prior to inclusion in the study panel, all of the candidates were briefed as to the purpose of the study, the procedure to which they would be subjected, and the hazards which might be anticipated as a consequence thereof. Parents of minors participating in this study were briefed along with their children so that parental consent could be obtained. Informed-consent forms were obtained from all individuals, the parents signing on behalf of the participating minors. The ages of the participants selected ranged from 2 to 65 years. Approximately 1/3 were males and 2/3 were females. The test materials were applied under occlusion for a series of effective contact periods of two days duration, i . e . , Monday to Wednesday and Wednesday to Friday of each week for four weeks. On Mondays the test materials were applied. On Wednesdays the patches were removed, the contact sites examined and the test materials reapplied for another 48 hour period. On Fridays, the covers were removed and the contact sites were again examined and graded. The contact sites were then rested until the following Monday. A mixture of the group of four materials was applied to a single predesignated contact site which was reserved for this specific group throughout the test. On each application day, 4% aqueous solutions were freshly made. Fifty ml of the solutions of each of the four test materials comprising each group were then mixed together and one ml was pipetted off to saturate a lintine disc, 1.25 in. in diameter. One such disc was placed intimately in contact with the contact site on each participant and covered with a water impermeable sheet of plastic (1.5 in. x 1.5 in.). The plastic was then affixed to the skin with Blenderm tape applied in such a manner so as to seal the edges and maintain the integrity of the micro-climate under the patch. On the second Monday following the removal of the last series of applications, each contact site was challenged with its corresponding composite of test materials. The covers were removed on Wednesday, thereby effecting a challenge contact period of 48 hours duration. The contact sites were examined for visible changes which, if present, were graded and recorded. Sites were re-examined 24 and 48 hours later for delayed reactions. At all reading periods it was found useful to wash the sites in order to remove the dye stuffs obscuring the underlying skin. Satisfactory washing was accomplished with the use of warm water and mild, gentle sponging. In those participants showing visible skin changes typical of irritation resulting from the application of the composite, an additional evaluation was undertaken to determine the particular offending material or materials.

Exposure assessment:

measured

Details on exposure:

Not available

Statistical methods:

Not available

Results and discussion

Results:

Group C-2
No visible skin changes signifying reaction to injury were observed in any of the subjects during the first, second, third, fourth, fifth, seventh and eighth applications.
Sixth Application - 2 Day's Duration (Third Week)
Visible skin changes signifying reaction to injury were observed in one subject, #9 who showed a 3+ reaction. No further applications were made to this subject until challenge.
Challenge Application
Visible skin changes signifying reaction to injury were observed in the following two subjects: #9 (3-t) and #177 (3+).
A total of two subjects reacted to Composite Group C-2. Both of these can be considered to have exhibited sensitization reactions. Both of these subjects were challenged with the separate components of Composite Group C-2 applied individually. Subject #9 showed 3+ reactions to Setacyl Yellow P-FL, 130-142-730 and to Setacyl Scarlet P-GBL, 130-295-770. Subject #177 although showing sensitization reactions to the Composite, did not react to any of the individual components. Neither subject showed reactions to the other two components.

Confounding factors:

Not available

Strengths and weaknesses:

Not available

Applicant's summary and conclusion

Conclusions:

Composite Group C-2, under the test conditions, was capable of eliciting visible skin changes consistent with the criteria deemed characteristic of a sensitizer in 2/200 subjects. Setacyl Yellow P-FL, 130-142-730 and Setacyl Scarlet. P-GBL, 130-295-770, when tested individually, were each capable of eliciting skin changes consistent with the criteria deemed characteristic of a sensitizer in one of the two subjects noted above. The other two components of this group, when tested individually, were not capable of eliciting visible skin changes consistent with the criteria deemed characteristic of a primary irritant, fatiguing agent or sensitizer in either of the two subjects noted above. It is the opinion of the investigator that Setacyl Yellow P-FL 130-142-730 or Setacyl Scarlet P-GBL 130-295-770 would constitute a hazard if they should remain in prolonged intimate contact with the skin. Setacyl Yellow P-4RL 130-140-700 or Setacyl Turquoise Blue G Supra 130-347-720 or a combination of the two may be considered innocuous under the normal use of such material as long as conditions of use do not exceed those under which it was evaluated herein.

Executive summary:

Composite Group C-2, under the test conditions, was capable of eliciting visible skin changes consistent with the criteria deemed characteristic of a sensitizer in 2/200 subjects. Setacyl Yellow P-FL, 130-142-730 and Setacyl Scarlet. P-GBL, 130-295-770, when tested individually, were each capable of eliciting skin changes consistent with the criteria deemed characteristic of a sensitizer in one of the two subjects noted above. The other two components of this group, when tested individually, were not capable of eliciting visible skin changes consistent with the criteria deemed characteristic of a primary irritant, fatiguing agent or sensitizer in either of the two subjects noted above. It is the opinion of the investigator that Setacyl Yellow P-FL 130-142-730 or Setacyl Scarlet P-GBL 130-295-770 would constitute a hazard if they should remain in prolonged intimate contact with the skin. Setacyl Yellow P-4RL 130-140-700 or Setacyl Turquoise Blue G Supra 130-347-720 or a combination of the two may be considered innocuous under the normal use of such material as long as conditions of use do not exceed those under which it was evaluated herein.