Reaction mass ofDisodium [1-{[2-(hydroxy-kO)-3,5-dinitrophenyl]diazenyl-kN1}naphthalen-2-olato(2-)-kO][3-(hydroxy-kO)-4-{[2-(hydroxy-kO)naphthalen-1-yl]diazenyl-kN1}-7-nitronaphthalene-1-sulfonato(3-)]chromate(2-) andDisodium [1-{[2-(hydroxy-kO)-3,5-dinitrophenyl]diazenyl-kN2}naphthalen-2-olato(2-)-kO][3-(hydroxy-kO)-4-{[2-(hydroxy-kO)naphthalen-1-yl]diazenyl-kN1}-7-nitronaphthalene-1-sulfonato(3-)]chromate(2-)

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Justification for type of information:

None

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

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The principle of the patch test is the application of the test product on the skin of the back of adults volunteers. The product is kept in contact with the skin for 48 hrs under occlusive patch. The clinical observation of the effects is carried out following the removal of the patch. 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 for 48 hrs. 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.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [1-[(2-hydroxy-3,5-dinitrophenyl)azo]-2-naphtholato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

EC Number:

274-487-5

EC Name:

Disodium [1-[(2-hydroxy-3,5-dinitrophenyl)azo]-2-naphtholato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Cas Number:

70236-55-4

Molecular formula:

C36H18CrN7O13S.2Na

IUPAC Name:

disodium [1-[(2-hydroxy-3,5-dinitrophenyl)azo]-2-naphtholato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Specific details on test material used for the study:

TEST MATERIAL IDENTIFIED AS: Composite of Irgalan Black RBL, Irgalan Black BGL, Irgalan Brown 3BL, Irganol Orange GRLS 200 %

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 200
- Sex: Not specified
- Age: Not specified
- Race: Not speciifed
- Demographic information: Not specified

Clinical history:

- Other: The criteria for qualifying were:
1. General well-being.
2. Absence of any skin disease which might be confused with skin reactions from the test material.
3. Willingness to cooperate.
4. Dependability and intelligence in following directions.
5. Reading, understanding, and signing an informed-consent contract. (In the case of minors,parental consent was obtained.)

Controls:

Not specified

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)

ADMINISTRATION & EXAMINATIONS:
The test material was applied under occlusion for a series of effective contact periods of two days' duration. 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. The following scoring system was used to grade skin reactions:
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.
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.

Results and discussion

Results of examinations:

Detailed gradings of the skin changes observed in each individual are attached in chart form.
1. Skin Changes Accompanying Application No. 1:
No visible skin changes signifying reaction to injury were observed in any of the 200 subjects.

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

3. Skin Changes Accompanying Challenge Application:
No visible skin changes signifying reaction to injury were observed in any of the 200 subjects.

Applicant's summary and conclusion

Conclusions:

The test item was not considered to be a primary irritant, fatiguing agent, or sensitizer under the tested conditions.

Executive summary:

The sensitising potential of the test item with respect to humans was evaluated in a repeated insult patch test. The test material was applied under occlusion twice a week for 4 weeks for a series of effective contact periods of two days' duration. On the second Monday following the removal of the last series of applications, the test material was applied to the same contact site as a challenge. The contact sites were examined for visible changes which, if present, were graded and recorded. Sites were re-examined twenty-four and fortyeight hours later for delayed reactions. No visible skin changes signifying reaction to injury were observed in any of the 200 subjects at any of the readings. Hence, based on the findings of the study, the test item was not considered to be a primary irritant, fatiguing agent, or sensitizer under the tested conditions.