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Administrative data

Description of key information

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)
Reference:
Composition 0
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The sensitization potential of D&C yellow 8 was determined by performing patch test on humans.
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
not specified
Test material information:
Composition 1
Species:
human
Strain:
other: not applicable
Sex:
not specified
Details on test animals and environmental conditions:
No data available
Route:
epicutaneous, occlusive
Vehicle:
other: Petrolatum
Concentration / amount:
1 % in petrolatum
Concentration / amount:
1 % in petrolatum
No. of animals per dose:
16 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
Positive control results:
No data available
Reading:
other: Non-sensitiser
No. with + reactions:
1
Total no. in group:
16
Clinical observations:
not sensitising
Remarks on result:
other: Reading:

 Patch test results

 

Chemical

No of patients tested

?+

+

++

D&C yellow 8 (1% in pet.)

16

0

0

1

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The sensitization potential of D&C yellow 8 was determined by performing patch tests on humans.
16 patients were tested with the dye. Only 1 positive reactions was reported by a patient.
D&C yellow 8 can be considered as a non- sensitizer in humans
Executive summary:

The sensitization potential of D&C yellow 8 was determined by performing patch tests on humans.

 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

16 patients were tested with the dye.Only 1 positive reactions was reported by a patient.

 D&C yellow 8 can be considered as a non- sensitizer in humans.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitization

Skin sensitization test by (Guin JD, 2003) for Sodium Fluorescein (518-47-8) was assessed in human. The sensitization potential of D&C yellow 8 was determined by performing patch tests on humans. 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 .16 patients were tested with the dye. Only 1 positive reaction was reported by a patient. D&C yellow 8 can be considered as a non- sensitizer in humans.

In other supporting study by (E. Nuceraet al, 2003) for Sodium Fluorescein (518-47-8) was assessed in human.Patch test was conducted on 1 human male patient to evaluate skin sensitising potency of chemical sodium Fluorescein. An allergological evaluation (patch tests) with 20% sodium Fluorescein was performed. Saline and histamine solutions were used, respectively, as negative and positive controls .The patch test result was negative. Hence, non-sensitising effects were observed in patch test conducted on human male patient applied with 20% sodium Fluorescein.

In another study by (C.Trindade-Porto, 1999) for Sodium Fluorescein (518-47-8) was assessed in human.Skin prick test was conducted to evaluate the skin sensitising potency of chemical sodium Fluorescein involving 2 case studies of 1 male and 1female. The protocol for adverse reactions to Fluorescein consists of performing a skin prick test with a 200 mg/ml concentration and intradermal reactions with 1/1000, 1/ 100, and 1/10 dilutions. A 50% glycerine saline solution and 1% histamine chloride are used for negative and positive controls, respectively. Whenever the skin tests are negative, a conjunctival provocation test with Fluorescein is performed.

Case A: Case A. A 23-year-old woman who presented hypotension, respiratory distress, and hand edema with itching and sensation of warmth after administration of intravenous fluorescein required urgent medical care and treatment with intravenous antihistamines and corticoids. Hours later, the patient suffered facial angioedema. She had not undergone any previous fluorescein tests. She reported no personal history of adverse reactions to other drugs. Skin prick tests performed with sodium fluorescein were positive with a 5-mm papule.

Positve reactions were known in skin sensitisation test of chemical Sodium Fluorescein exposed to 2 human pateints in skin prick test.

Case B. -A 75-year-old man who, after the administration of intravenous fluorescein, immediately presented intense respiratory distress and loss of consciousness required urgent medical treatment with epinephrine, serum therapy, and corticoids. The patient did not mention any previous angiographies. There was no significant personal history. Given the high risk of this patient, the prick test was performed with sodium fluorescein at a 1/1000 dilution (0.2 mg/ml), and it was positive with a 6-mm papule.

Positve reactions were known in skin sensitisation test of chemical Sodium Fluorescein exposed to 2 human pateints in skin prick test.

In another study by (Beleña JM et al, 2013) for Sodium Fluorescein (518-47-8) was assessed in human.An intradermal skin test for predicting an anaphylactoid reaction to i. v. injection of Fluorescein solution was performed in 196 patients. Sodium Fluorescein was applied to the skin of 196 male and female patients with 0.2 ml of intradermal injections. Only 12 patients of 196 tested showed positive reactions. These results are consistent with previous studies. Hence, the chemical sodium fluorescence was considered to be non-sensitising to the skin of humans.

In another supporting study by (Dimitrios C. Kalogeromitros, 2011) for Sodium Fluorescein (518-47-8) was assessed in human.Patients with adequate indication for Fluorescein angiography and normal skin responsiveness were subjected to allergy skin-prick and intradermal tests for Fluorescein, followed by SFA (sodium Fluorescein angiography). One thousand and thirty-seven patients were enrolled in the study Possible sensitization to fluorescein was evaluated through skin-prick and intradermal tests. For the skin-prick tests, increasing concentrations of sodium Fluorescein were used successively (1⁄100, 1⁄10, 1⁄1 dilutions of the full-strength preparation). Intradermal tests were performed using a 1⁄100 dilution of Fluorescein 100 mg ⁄ ml (sodium Fluorescein 10%; Institute of Pharmacological Research and Technology, Pallini, Greece). Histamine chloride (10 mg ⁄ml; Stallergenes, Paris, France) and 50% glycerine saline solution were used as positive and negative controls, respectively. Intervals of 20 min were kept between each test. Wheal and flare reactions typical of mast-cell activation were evaluated and documented by the allergologist conducting the tests. Prick tests with a wheal diameter at least 3 mm larger than the one produced by the negative control were considered positive. During the intradermal testing, any occurring wheal and flare reaction with a wheal diameter‡5 mm was also considered positive. This study was performed in accordance with the tenets of the Declaration of Helsinki. None of the reactors produced positive skin tests to Fluorescein. Sodium Fluorescein is non – sensitizing to humans.

On the basis of majority of available information for the target, the test substance can be considered as not sensitising to the skin.


Migrated from Short description of key information:
Skin sensitization test by (Guin JD, 2003) for Sodium Fluorescein was assessed in human. The sensitization potential of D&C yellow 8 was determined by performing patch tests on humans. 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 .16 patients were tested with the dye. Only 1 positive reaction was reported by a patient.

Justification for selection of skin sensitisation endpoint:
Skin sensitization test by (Guin JD, 2003) for Sodium Fluorescein was assessed in human. The sensitization potential of D&C yellow 8 was determined by performing patch tests on humans. 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 .16 patients were tested with the dye. Only 1 positive reaction was reported by a patient. D&C yellow 8 can be considered as a non- sensitizer in humans.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance Sodium Fluorescein can be classified as “non-sensitizer” based on the majority of studies.