Reaction mass of Chromate(1-), [N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthalenyl]acetamidato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-, hydrogen, compd. with N-cyclohexylcyclohexanamine (1:1) and hydrogen bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with dicyclohexylamine (1:1) and hydrogen bis[N-[7-hydroxy-8-[(2-hydroxy-5-nitrophenyl)azo]-1-naphthyl]acetamidato(2-)]chromate(1-) , compound with dicyclohexylamine (1:1)

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

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 followed

Principles of method if other than guideline:

The test item was tested on 200 volunteers in a series of 8 48-hour applications. The test item was applied under occlusion for effective contact periods of 2-days duration. If no reactions occurred, the test item was re-applied immediately for another 48-hour period.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

12237-23-9

Specific details on test material used for the study:

- Name of test material (as reported in study report): Orasol Black CN

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 200

Clinical history:

Criteria for qualifying included absence of any skin disease which might be confused with skin reactions from the test material.

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: Repeated Insult Patch Test

ADMINISTRATION
- Type of application: occlusive
- Description of patch: 3 cm x 3 cm
- Concentrations: 50%
- Testing/scoring schedule: every 48 h
- Removal of test substance: 48 h

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.

Results and discussion

Results of examinations:

No visible skin changes signifying reaction to injury were observed in any of the 200 subjects.