2-(4-amino-2-nitroanilino)ethanol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

From 5 March 1984 to 12 June 1984

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:

1984

Report date:

1984

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 entire study extended over a six weeks period with three phases: induction, rest and challenge. The induction phase consisted of 10 consecutive applications of the test material. The patches were removed 24 hours after application and evaluated each 48 hours. The challenge phase was initiated during the sixth week of the study, with identical patches applied to a unexposed site to the test material. Patches were removed after 48 hours. The sites were graded 48 and 72 hours after removal.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-(4-amino-2-nitroanilino)ethanol

EC Number:

220-701-7

EC Name:

2-(4-amino-2-nitroanilino)ethanol

Cas Number:

2871-01-4

Molecular formula:

C8H11N3O3

IUPAC Name:

2-(4-amino-2-nitroanilino)ethanol

Test material form:

semi-solid (amorphous): gel

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Product No. 1431282
- Expiration date of the lot/batch:not specified
- Purity test date: not specified

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: keep unused in refrigerator

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The samples were prepared at a level of 3.0% with : Tween 80 (2.0%), Natrosol (2.0%), Sodium Sulfite (0.05%), Carbitol (6.0%), Hexyleneglycol (4.0%), Water (q.s. 100)

Method

Type of population:

not specified

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 115 enrolled ; 100 completed cases
- Sex: male & female
- Age: 19-79
- Race: not designated
- Demographic information: Causaian; Negroid, Hispanic and Other (no more details)

Controls:

No control was used in the study

Route of administration:

inhalation

Details on study design:

TYPE OF TEST(S) USED: patch test (epicutaneous test)
- Type of application: semi-occlusive
- Description of patch: A 1.4cm square blotting paper affixed with Scanpor tape
- Vehicle / solvent: Formulation : The samples were prepared at a level of 3.0% with : Tween 80 (2.0%), Natrosol (2.0%), Sodium Sulfite (0.05%), Carbitol (6.0%), Hexyleneglycol (4.0%), Water (q.s. 100)
- Concentrations: 3%
- Volume applied: 0.1 mL
- Testing/scoring schedule: 48 hours after patch application
- Removal of test substance: 48 and 72 hours after application

EXAMINATIONS
Grading/Scoring system
-No reaction
- Doubtful response, barely perceptible erythema, only slighty different from surrounding skin
- Definite erythema (minimal or doubtful edema)
- Minimal or doubful edema
- Definite erythema
- Definite edema
- Definite erythema (definite edema and vesiculation)

-Statistical analysis : not specified

Results and discussion

Results of examinations:

There were neither irritation nor sensitisation reactions in the study.

Applicant's summary and conclusion

Conclusions:

Under the experimental conditions of the study, the test substance H.C. Red No. 3 did not induce sensitization effect on voluntary subjects in a Human Repeated Insult Patch Test.

Executive summary:

The purpose of the non GLP-compliant study was to evaluate the potential sensitizer effect of the test item H.C. Red No. 3 on human with a Human Repeated Insult Patch Test.

115 subjects were used in this study. The entire study extended over a six weeks period with three phases: induction, rest and challenge. The induction phase consisted of 10 consecutive applications of the test material. The patches were removed 48 hours after application and skin evaluated each 48 hours. The challenge phase was initiated during the sixth week of the study, with identical patches applied to sites on the opposite site previously unexposed to the test material. Patches were removed after 48 hours. The sites were grades 48 and 72 hours after removal.

Under the experimental conditions of the study, the test substance H.C. Red No. 3 in hayr dye base did not induce sensitization effect on voluntary subjects in a Human Repeated Insult Patch Test.