Reaction products of diazotized 2-amino-4-(methylsulfonyl)-phenol with 2-(3-Chlorophenyl)-2,4-dihydro-5-methyl-3H-pyrazol-3-one and Methyl-7-hydroxy-1-naphthylcarbamate – and chromium (III) 2:1, salted by ammonium, sodium and acid

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted standards, well documented and acceptable for assessment. No data on purity of test substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1965

Report date:

1966

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

Thirty adults and twenty-three children were used in this study. The test material was applied to linteen discs approximately 0.5 square inches in diameter. These were then applied to the upper arms of the subjects and covered by an occlusive patch, being held in place with Blenderm Tape (3 M). After 24-hours the patch was removed and the reactions graded and recorded. A rest period of 24-hours then elapsed after which the patches were reapplied as before. This sequence was repeated until 15 successive patches had been applied. A two-week rest period was then allowed after which a challenge application was applied in a manner similar to the primary patches. In addition a control material consisting of Ivory soap, as a 1% w/v slurry in distilled water, was applied concurrently and in the same manner as the test material.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Irgacet Brown 2GL

IUPAC Name:

Irgacet Brown 2GL

Details on test material:

Purity: No data.

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed:
30 adults, 23 children

Clinical history:

no data

Route of administration:

dermal

Details on study design:

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

ADMINISTRATION
- Type of application: occlusive
- Description of patch: The test material was applied on linteen discs approximately 0.5 square inches in diameter. These were then applied to the upper arms of the subjects and covered by an occlusive patch, being held in place with Blenderm Tape (3 M).
- Vehicle / solvent: no data
- Concentrations: no data
- Volume applied: no data
- Testing/scoring schedule: After 24 h exposure the patch was removed and the reactions were scored. This sequence was repeated until 15 successive patches had been applied. A two-week rest period was then allowed after which a challenge application was applied in a manner similar to the primary patches. In addition a control material consisting of Ivory soap, as a 1% w/v slurry in distilled water, was applied concurrently and in the same manner as the test material.
- Removal of test substance: no data

EXAMINATIONS
- Grading/Scoring system:
0 = No reaction.
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:

SYMPTOMS
- Frequency, level, duration of symptoms observed:
The test material produced reactions in 21 subjects of whom 9 subjects, 6 adults and 3 children, showed 2+ reactions
indicative of moderate fatiguing effects.

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
Test substance:
- Number of subjects with positive reactions: 0/53
- Number of subjects with negative reactions: 53/53
- Number of subjects with irritating reactions while induction period: 21/53

Control substance (ivory soap):
- Number of subjects with positive reactions: 4/53
- Number of subjects with negative reactions: 49/53
- Number of subjects with irritating reactions while induction period: 31/53


RESULT OF STUDY:
Irgacet Brown 2GL was neither a primary irritant nor sensitizer to any of the test subjects under the test conditions. The test material is significantly less irritating than a 1% Ivory soap preparation under the same test conditions.
Insofar as sensitization is concerned, the significance of extrapolating these results to a general population is statistically limited by the number of the test subjects. From this test in which approximately 50 subjects were used, it may be predicted with a confidence of being correct in 19 out of 20 cases that Irgacet Brown 2GL will be safe to use by 90 out of every 100 people under conditions not exceeding those of this test in severity.