Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate

Endpoint summary

Description of key information

No positive reactions were reported by any of the 9 patients tested. The test chemical can be considered as a non- sensitizer in humans.

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 to determine the allergic contact dermatitis caused by the chemical

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

not specified

Species:

other: humans

Strain:

not specified

Sex:

male/female

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

50% in petrolatum

Day(s)/duration:

2-3 days

Adequacy of induction:

not specified

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

petrolatum

Concentration / amount:

50% in petrolatum

Day(s)/duration:

2-3 days

Adequacy of challenge:

not specified

No. of animals per dose:

9 patients

Details on study design:

Details on study design
OTHER: The dye was applied in Finn Chambers and read first at 2 or (more commonly) 3 days and
again at 4–7 days.
The reactions of the patients were graded as?+. + and ++ categories.

Challenge controls:

no data available

Positive control substance(s):

not specified

Key result

Reading:

1st reading

Hours after challenge:

72

Group:

test chemical

Dose level:

50% in petrolatum

No. with + reactions:

0

Total no. in group:

9

Clinical observations:

no dermal reactions observed

Remarks on result:

no indication of skin sensitisation

Table 1:  Patch test results

 

Chemical	No of patients tested	?+	+	++
17372 -87 -1 (50% petrolatum.)	9	0	0	0

Interpretation of results:

other: not sensitizing

Conclusions:

9 patients were tested with the dye.No positive reactions were reported by any of the 9 patients tested. The test chemical can be considered as a non- sensitizer in humans.

Executive summary:

The sensitization potential of the test chemical was determined by performing patch tests on humans. 9 patients were tested with the test chemical.

50% test chemical in petrolatum was applied in Finn Chambers to the skin of 9 patients. The reactions were first read at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories

No positive reactions were reported by any of the 9 patients tested. The test chemical can be considered as a non- sensitizer in humans.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Various studies have been reviewed to determine the allergenic potential of the test chemical in living organisms. These include experimental results performed on humans for the test chemical. The studies are summarized as follows:

The sensitization potential of the test chemical was determined by performing patch tests on humans. 9 patients were tested with the test chemical.

50% test chemical in petrolatum was applied in Finn Chambers to the skin of 9 patients. The reactions were first read at 2 or (more commonly) 3 days and again at 4–7 days. The reactions of the patients were graded as ‘?+ ‘ , ‘+’ and ‘++’ categories

No positive reactions were reported by any of the 9 patients tested. The test chemical can be considered as a non- sensitizer in humans.

In similar manner patch test was conducted on 81 year old male patient with a history of recurrent leg dermatitis to determine the contact sensitization caused by the test chemical.

The test material was applied to the upper back with Micropore (3M, Minnesota) tape at concentration of 50% in petrolatum. Patches were removed after 2 days and a second reading was made at 3 days. Reactions were recorded according to the ICDRG scoring system.

 After 2 months he was again patch tested with test chemical at dose of 1% in petrolatum which produced strong allergic reaction (++).

Strong allergic reaction (++) was obtained when the patient was tested with 1% in petrolatum. Therefore the test chemical was considered as skin sensitizing to the skin.

This is supported by the results of a study in which a patch test was conducted on a 24 year old tennis player who had a 5 month history of an unhealed itching injury on his left leg to assess sensitization potential of test chemical.

 The test material was applied to the upper back with Micropore (3M, Minnesota) tape at concentration of 1% and 50% in petrolatum. Patches were removed after 2 days and a second reading was made at 3 days. Reactions were recorded according to the ICDRG scoring system.

The patient developed strong positive reaction (++) at both the tested concentration. Hence the test chemical was considered as sensitizing to the skin.

These results are further supported by a study where a patch test was conducted on a 64 year old female patient with a past history of recurrent contact dermatitis with an extensive leg ulcer due to the test chemical.

The test material was applied to the upper back with Micropore (3M, Minnesota) tape at concentration of 2% (aqueous) and 50% (Petrolatum). Patches were removed after 2 days and a second reading was made at 3 days. Reactions were recorded according to the ICDRG scoring system.

Strong allergic reaction was observed in treated patients at dose of 2% aq. (++) and 50% petro (+++).  

Hence the test chemical was considered as sensitizing to the skin.

The above results are supported by a study where patch test was conducted on 64 year old female patient suffering from ulcus cruis developed erythema and vesicles on her right leg and right forearm due to exposure to the test chemical. The test material was applied to the upper back with Micropore (3M, Minnesota) tape at concentration of 2% (aqueous) and 1% and 50% (petrolatum). Patches were removed and a second reading was made after 2 days. Reactions were recorded according to the ICDRG scoring system.

Since the chemical produced allergic skin reaction at the tested concentration, the test chemical was considered as sensitizing to the skin.

Eventhough the key study claims that the test chemical does not cause any dermal reactions in 9 patients, but strong allergic reactions were observed in the remaining studies. Taking in to consideration the results of the majority supporting studies, the test chemical can be considered to cause an allergic reaction to skin. Hence, it can be considered to be a potential skin sensitizer. Comparing the annotations with the criteria of CLP, the test chemical can be classified under the category “Skin Sensitizer 1”.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Eventhough the key study claims that the test chemical does not cause any dermal reactions in 9 patients, but strong allergic reactions were observed in the remaining studies. Taking in to consideration the results of the majority supporting studies, the test chemical can be considered to cause an allergic reaction to skin. Hence, it can be considered to be a potential skin sensitizer. Comparing the annotations with the criteria of CLP, the test chemical can be classified under the category “Skin Sensitizer 1”.