1-(2-methyl-4-(2-methylphenylazo)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:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

Scarlet red allergy

Author:

Garrigues NW, Carraway JH

Year:

1983

Bibliographic source:

Plast Reconstr Surg. Jan; 71(1):123-5

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Patch test

Principles of method if other than guideline:

Patch test was performed on humans to determine the irritation potential of the test chemical

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-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol

EC Number:

201-635-8

EC Name:

1-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol

Cas Number:

85-83-6

Molecular formula:

C24H20N4O

IUPAC Name:

1-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol

Details on test material:

- Name of test material (as cited in study report): SCARLET RED
- Molecular formula (if other than submission substance): C24H20N4O
- Molecular weight (if other than submission substance): 380.45
- Substance type: Organic
- Physical state: Solid

Specific details on test material used for the study:

Details on test material
- Name of test material (as cited in study report): Scarlet red
- Molecular formula : C24H20N4O
- Molecular weight : 380.449 g/mol
- Substance type: Organic
- Physical State: Solid

In vivo test system

Test animals

Species:

other: Human

Strain:

not specified

Remarks:

Not applicable

Sex:

female

Details on test animals and environmental conditions:

Details on test animal
TEST ANIMALS
- Source: Department of Plastic Surgery, Eastern Virginia Graduate School of Medicine
- Age at study initiation: 54 year old
- Weight at study initiation: No data available

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

5%

Day(s)/duration:

48 hours

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

5%

Day(s)/duration:

48 hours

Adequacy of challenge:

not specified

No. of animals per dose:

1 human female

Details on study design:

Details on study design
After a skin graft surgery. The patient was reported with pruritus especially to the donar site. The donar site was dressed with scarlet red guaze.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: single
- Exposure period: 48 hour
- Test groups: test site
- Control group: Positive test sites.
- Site: No data available.
- Frequency of applications: No data available
- Duration: 48 hour
- Concentrations: 5%

B. Challenge Exposure
- No. of exposures: single
- Exposure period: 48 hour
- Test groups: test site
- Control group: Positive test sites.
- Site: No data available.
- Frequency of applications: No data available
- Duration: 48 hour
- Concentrations: 5%

Challenge controls:

23 commonly encountered Allergen were used in patch test

Positive control substance(s):

yes

Results and discussion

Positive control results:

No reaction was observed.

In vivo (non-LLNA)

Results

Key result

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

5%

No. with + reactions:

1

Total no. in group:

1

Clinical observations:

Sensitization index score; ++++(Erosive)

Remarks on result:

positive indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

other: sensitizing

Conclusions:

A +++ reaction was obtained with the test chemical present as a part of the scarlet red gauze. Hence, the test chemical can be considered to be sensitizing to skin.

Executive summary:

The study reports a case of contact dermatitis to the test chemical present in the ointment gauze dressings.

A 54 year female peanut factory worker presented with hypertrophic and contracted burn scars of the left thorax and axilla, the sequelae of flame burns suffered at age 4. She reported multiple prior skin graft (split and full thickness) and local flap reconstructive procedures for this problem. Unremembered types of powder and gauze were used to donor sites in those prior operations. The patient denied medicinal allergies, including sulfonamides. She did relate a specific pruritic eruption, generalized and not limited to the hands that occurred when she used inexpensive orange and red dyes fruit or flowers in her hobby of flower arrangement. This problem was relieved by steriods.

The patient underwent release of burn-scar contractures with split-thickness skin graft reconstruction. Three days following the surgery, the patient reported an increasing pruritus licalized specifically to the split-graft donor site. This wound was inspected and an intense erythematous vesilobullous peripheral reaction was noted. The scarlet red gauze was coated with fibrinolysis and de-oxyribonuclear, combined(bovine). This coupled with continuous saline soaks, allowed the removal of the gauze. The donor site was left open to air-dry and the inflames periphery was treated.

A recovery was observed. The donor site healed without any difficulty and the graft manifested completed. 3 months later , the patient was patch tested with each of the ingredients of the scarlet red gauze and 23 commonly contacted contact allergens. The patient had 48 hours epicutaneous exposure to these patches.

A +++ reaction was obtained with the test chemical present as a part of the scarlet red gauze. Hence, the test chemical can be considered to be sensitizing to skin.