1-phenylazo-2-naphthol

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

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

Justification for type of information:

Data is from peer reviewed journal

Data source

Reference

Reference Type:

publication

Title:

Occupational pigmented contact dermatitis from azo-dyes

Author:

Keiichi Fujimoto, Sehchi Hashimoto, Takehito Kozuka, Minoru Tashiro and Shigemaru Sano

Year:

1985

Bibliographic source:

Contact Dermatitis 12: 15-17

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

To evaluate the skin sensitizing potential of 1-phenylazo-2-naphthol (Sudan I) in human by patch test.

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1-phenylazo-2-naphthol

EC Number:

212-668-2

EC Name:

1-phenylazo-2-naphthol

Cas Number:

842-07-9

Molecular formula:

C16H12N2O

IUPAC Name:

1-[(E)-2-phenyldiazen-1-yl]naphthalen-2-ol

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Solvent yellow 14
- Molecular formula (if other than submission substance): C16H12N2O
- Molecular weight (if other than submission substance): 248.28 g/mole
- InChl (if other than submission substance):1S/C16H12N2O/c19-15-11-10-12-6-4-5-9-14(12)16(15)18-17-13-7-2-1-3-8-13/h1-11,19H/b18-17+
- Substance type: Organic
- Physical state: Solid
- Analytical purity: No data
- Impurities (identity and concentrations): No data

Specific details on test material used for the study:

Details on test material
Name of test material (as cited in study report): Sudan I
Molecular formula: C16H12N2O
Molecular weight: 248.284 g/mol
Physical State: Solid
Substance type: Organic

In vivo test system

Test animals

Species:

other: Human

Strain:

other:

Remarks:

Not applicable

Sex:

male

Details on test animals and environmental conditions:

Details on test animal
TEST ANIMALS
- Source: No data available
- Age at study initiation: 51 years old
- Weight at study initiation: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%): No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available

Study design: in vivo (non-LLNA)

Induction

Route:

other: not specified

Vehicle:

unchanged (no vehicle)

Concentration / amount:

1%

Day(s)/duration:

48 hour

No. of animals per dose:

1 human male

Details on study design:

Details on study design
RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 1
- Exposure period: 48 hours
- Test groups: yes
- Control group: No data available
- Site: Back
- Frequency of applications: No data available
- Duration: 48 hour
- Concentrations: 1 %

OTHER:
- Evaluation (hr after induction exposure): 1hour and at 24 hour after removal of patch

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Key result

Reading:

other: both 1and 2nd reading

Hours after challenge:

24

Group:

test chemical

Dose level:

1%

No. with + reactions:

2

Clinical observations:

Test area became pigmented.

Remarks on result:

positive indication of skin sensitisation

Any other information on results incl. tables

The test result was read according to ICDRG classification.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (skin sensitising) based on GHS criteria

Conclusions:

The substance 1-phenylazo-2-naphthol (Sudan I) was observed for its sensitizing potential in human. Sudan I was considered to be sensitizing in human male by patch test.

Executive summary:

A 51-year-old man had been working in dye factory for 25 years and had noticed itching and pigmentation on the extremities for the past 5 years. On examination there were erythematous lesions, lichenification and pigmentation, diffusely and symmetrically over the dorsa of the hands, feet and legs. Patch test was performed having concentration of Sudan I is 1%. They were applied on the back for 48 hours, and the test read 1h and 24 h after removal according to the ICDRG Classification. Positive reaction was observed for to 1-phenylazo-2-naphthol (Sudan I).Therefore 1-phenylazo-2-naphthol (Sudan I) was considered to be a skin sensitizer and can be classiffied as sensitizer1 according to GHS criteria.