Disodium 5-(benzoylamino)-4-hydroxy-3-[[2-(2-methylphenoxy)phenyl]azo]naphthalene-2,7-disulphonate

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Well-documented study report which meets basic scientific principles, but low purity of the substance in the tested mixture.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Repeated Insult Patch Test was performed on 200 human volunteers to determine if the test material is capable of irritating the skin of humans under controlled test conditions. The test material was applied under occlusion for a series of effective contact periods of two days' duration. If no reactions occurred, the test material was re-applied immediately for another forty-eight-hour period. This cycle was repeated for three more weeks, so that a series of eight forty-eight-hour applications were completed. in addition, Sites were re-examined twenty-four and forty-eight hours later for delayed reactions.

GLP compliance:

no

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 5-(benzoylamino)-4-hydroxy-3-[[2-(2-methylphenoxy)phenyl]azo]naphthalene-2,7-disulphonate

EC Number:

274-434-6

EC Name:

Disodium 5-(benzoylamino)-4-hydroxy-3-[[2-(2-methylphenoxy)phenyl]azo]naphthalene-2,7-disulphonate

Cas Number:

70210-37-6

Molecular formula:

C30H21N3O9S2.2Na

IUPAC Name:

disodium (E)-5-benzamido-4-hydroxy-3-((2-(otolyloxy)phenyl)diazenyl)naphthalene-2,7-disulfonate

Method

Type of population:

general

Ethical approval:

confirmed, but no further information available

Subjects:

Number of subjects exposed: 200
The criteria for qualifying were:
- General well-being.
- Absence of any skin disease which might be confused with skin reactions from the test material.
- Willingness to cooperate.
- Dependability and intelligence in following directions.

Route of administration:

dermal

Details on study design:

TYPE OF TEST USED: Repeated insult patch test

ADMINISTRATION
- Type of application: occlusive
- Description of patch: size 3 cm x 3 cm
- Removal of test substance: after two days
- Tested as: composite 4 %

PROCEDURE
On Monday, the test material was applied. The participants were instructed to contact the laboratory and inform the investigator immediately if any discomfort was felt at the patch site. On Wednesdays, the patches were removed, the contact sites examined, and the reactions, if any, were graded and recorded. If no reactions occurred, the test material was re-applied immediately for another forty-eight-hour period. The participants were instructed to call the laboratory on Thursday if any discomfort was felt. On Friday, the covers were removed and the contact sites were again examined and graded. The contact sites were then rested until the following Monday. This cycle was repeated for three more weeks, so that a series of eight forty-eight-hour applications were completed.
On the second Monday following the removal of the last series of applications, the test material was applied to the same contact site. The covers were removed on Wednesday, thereby effecting a challenge contact period of forty-eight hours' duration. The contact sites were examined for visible changes which, if present, were graded and recorded. Sites were re-examined twenty-four and forty-eight hours later for delayed reactions.

EXAMINATIONS
- Grading/Scoring system:
0 = No reactions.
1+ = Slight erythema.
2+ = Marked erythema.
3+ = Marked erythema, edema, with or without a few vesicles.
4+ = Marked erythema, edema, with vesicles and oozing.
- Other: Sites were re-examined twenty-four and forty-eight hours later for delayed reactions.

Results and discussion

Results of examinations:

No. of person with/without reactions compared to study population:
- Number of subjects with positive reactions: 1
- Number of subjects with negative reactions: 199

- Skin Changes Accompanying Application No. 1:
No visible skin changes signifying reaction to injury were observed in any of the 200 subjects.
- Skin Changes Accompanying Application Nos. 2 through 8:
Visible skin changes signifying reaction to injury were observed in 1 out of 200 subjects.
- Skin Changes Accompanying Challenge Application:
No visible skin changes signifying reaction to injury were observed in any of the 200 subjects.

Reaction of the case reported: marked erythema during application number 2 and 3

Any other information on results incl. tables

Summary of reaction grades:

	Number of reaction in grades indicated
Number of application	0	1+	2+	3+	4+	NP
1	200	0	0	0	0	0
2	199	0	1	0	0	0
3	199	0	1	0	0	0
4	200	0	0	0	0	0
5	200	0	0	0	0	0
6	200	0	0	0	0	0
7	200	0	0	0	0	0
8	200	0	0	0	0	0
Challenge	200	0	0	0	0	0

Applicant's summary and conclusion

Conclusions:

The test substance did elicit visible skin changes consistent with a fatiguing agent in 1 out of 200 subjects.

Executive summary:

Repeated Insult Patch Test was performed on 200 human volunteers.The test material was applied under occlusion for a series of effective contact periods of two days' duration.

The test substance was not capable of eliciting visible skin changes consistent with the criteria deemed characteristic of a primary irritant or sensitizer. It did elicit visible skin changes consistent with a fatiguing agent in 1 out of 200 subjects.