2-[(2-nitrophenyl)amino]ethanol

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

From 17 September 1984 to 25 October 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

During induction, observation of test area was performed 48 hours after application, the site should be observed 3 hours after patch removal.

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 available

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 9 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 sites on the opposite arm previously unexposed to the test material. Patches were removed after 24 hours. The sites were graded at 24 and 48 hours after removal.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-[(2-nitrophenyl)amino]ethanol

EC Number:

225-555-8

EC Name:

2-[(2-nitrophenyl)amino]ethanol

Cas Number:

4926-55-0

Molecular formula:

C8H10N2O3

IUPAC Name:

2-[(2-nitrophenyl)amino]ethanol

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Batch No. 2181083
- 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
- Stability under test conditions:not specified
- Solubility and stability of the test substance in the solvent/vehicle:not specified

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
Apply as received

Method

Type of population:

general

Ethical approval:

confirmed, but no further information available

Subjects:

- Number of subjects exposed: 104
- Sex: Male/Female
- Age: 18-79
- Race: Not designated
- Demographic information: Caucasoid, Negroid, Mongoloid, Hispanic

Controls:

No control was used in the study

Route of administration:

dermal

Details on study design:

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

ADMINISTRATION
- Type of application: occlusive
- Description of patch: Parke-Davis Readi Bandage affixed with Scanpor tape
- Vehicle / solvent: Isopropanol (12%), Tween-80 (2.0%), Natrosol (2.0%), Na sulfite (0.05%), water (q.s. 100)
- Concentrations: 3%
- Volume applied: 0.1 mL
- Testing/scoring schedule: The sites were grades 24 and 48 hours after removal.
- Removal of test substance: Patches were removed after 24 hours.

EXAMINATIONS
- Grading/Scoring system: Response observed during the test :
-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: The numerical equivalent of the strongest reaction obtained during challenge will be compared to the numerical equivalent of the strongest reaction obtained during induction (reactions felt to be indicative of sensitization during induction will be excluded) for each panelist. If greater than or equal to 3% of panelists have a "numerocal equivalent" difference greater than or equal to 1 point (challenge score greater than induction score) this result will be considered to be evidence for sensitization according to the following scale :
- No evidence of sensitization when "x" is less than 3%
- Interpretation may vary as discussed below when 3%<"x"<5% ("x" is greater than or equal to 3%, but less than 5%)

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: Only two subjects developed reactions on challenge that required further testing to rule out sensitization. They were rechallenged to the test item on the back and forearm using occlusive and semi occlusive patches. The result indicated irritation but no sensitization to the test substance.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions 96
- Number of subjects with equivocal reactions 0
- Number of subjects with irritating reactions 2

RESULT OF CASE REPORT: The result indicated irritation but no sensitization to the test substance on the two subjects which developed reactions on the first challenge.

Any other information on results incl. tables

Table 1 :Summary of results

	Induction Phase										Challenge
	1	2	3	4	5	6	7	8	9	10	1	2
Number of subjects	99	99	98	100	99	94	98	99	99	98	97	97
No reaction	99	98	98	97	98	93	96	92	92	91	95	95
Doubtful response, barely perceptible erythema, only slighty different from surrounding skin	0	1	0	3	1	1	2	7	7	7	1	1
Definite erythema											1	1
Definite erythema with minimal or doubtful edema
definite erythema with definite edema
definite erythema with definite edema andvesiculation

 

Applicant's summary and conclusion

Conclusions:

Under the experimental conditions of the study, the test substance H.C. Yellow No. 2 did not induce sensitization effect on human on 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. Yellow No. 2 on human with a Human Repeated Insult Patch Test.

104 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 9 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 sites on the opposite arm previously unexposed to the test material. Patches were removed after 24 hours. The sites were grades 24 and 48 hours after removal.

Two subjects developed reactions on challenge and were re-challenged. The results indicate irritation but not sensitization.

Under the experimental conditions of the study, the test substance H.C. Yellow No. 2 did not induce sensitization effect on human on a Human Repeated Insult Patch Test.