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

Endpoint summary

Description of key information

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.

 

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

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

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

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

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

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

5%

Day(s)/duration:

48 hours

Adequacy of induction:

not specified

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

Positive control results:

No reaction was observed.

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Various studies have been summarized to determine the extent of dermal sensitization caused by the test chemical in living organisms. These results include in vivo experimental studies as well as in vitro experimental study for the test chemicals.

 

 

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 surgey, 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.

The above result is supported by another case study which reports a case of contact dermatitis to the test chemical present in the ointment gauze dressings.

A 55 year old male educator was presented with a non-healing ulcer of the lower right pretibial area. The patient initially suffered an ipen tibia fibular fracture at age 10. Chronic osteomyelitis and a draining wound were the sequelae that caused long serious of operative procedures. A prior episode of deep vein thrombophlebitis had occured. He was not aware of the dressings used on prior donor sites and the allergic history was negative. A split thickness skin graft donor site was dressed with scarlet red gauze. Three days following the surgery the patient developed an intense blistering eruption in a field of erythema peripheral to the donor site. Itching was not severe. Scarlet red gauze was removal was effected with continuous saline soaks and whirlpool. The donor site was redreseed with petrolatum dressing and the erythematous lesion was treated with 0.1% triamcinolone oitnemnt 3 times daily. A 48 hour epicutaneous occlusive patch test with each of the ingredients of the scarlet red ointment dressing was applied. In addition the patches were tested to 23 commonly encountered contact allergens

A ++++(erosive) 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.

 

Available studies fortest chemicalindicate that it may cause an allergic reaction to the skin.

Hence, the test chemical can be considered to be sensitizing to skin.

 

 

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Available studies for test chemical indicate that it may cause an allergic reaction to the skin.

Hence, the test chemical can be considered to be sensitizing to skin.