Disodium 4-hydroxynaphthalene-2,7-disulphonate

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:

other:

Justification for type of information:

data from peer reviewed journals

Data source

Reference

Reference Type:

publication

Title:

Patch testing to FD&C and D&C dyes.

Author:

Guin JD.

Year:

2003

Bibliographic source:

Contact Dermatitis 2003: 49: 217–218

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

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

GLP compliance:

not specified

Type of study:

patch test

Justification for non-LLNA method:

The available data is sufficient for the classification of the substance thus non LLNA mehtod is accepatble. Also data is from relaible sources which confirm the classfication of the substance.

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 8-hydroxypyrene-1,3,6-trisulphonate

EC Number:

228-783-6

EC Name:

Trisodium 8-hydroxypyrene-1,3,6-trisulphonate

Cas Number:

6358-69-6

Molecular formula:

C16H10O10S3.3Na

IUPAC Name:

trisodium 8-hydroxypyrene-1,3,6-trisulfonate

Constituent 2

Reference substance name:

D&C Green 8 also known as Pyranine

IUPAC Name:

D&C Green 8 also known as Pyranine

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Name of test material (as cited in study report): Solvent Green 7 also known as Pyranine
Molecular formula : C16H10O10S3.3Na
Molecular weight : 524.385088g/mol
Smiles notation : c12c3c4c(cc(c3ccc2c(S([O])(=O)=O)cc(c1cc4)S([O])(=O)=O)O)S([O])(=O)=O.[Na+].[Na+].[Na+]
InChl : 1S/C16H10O10S3.3Na/c1711512(27(18,19)20)8341014(29(24,25)26)613(28(21,22)23)9217(11)15(8)16(9)10;;;/h16,17H,(H,18,19,20)(H,21,22,23)(H,24,25,26);;;/q;3*+1/p3
Substance type: Organic
Physical State: Solid

In vivo test system

Test animals

Species:

human

Sex:

male/female

Details on test animals and environmental conditions:

Source: test results of persons tested in my(author's) practice

Study design: in vivo (non-LLNA)

Induction

Route:

other: patch test

Vehicle:

petrolatum

Concentration / amount:

2%

Challenge

No.:

#1

Route:

other: no data

Vehicle:

petrolatum

Concentration / amount:

2%

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

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Group:

test chemical

Dose level:

2% in pet.

No. with + reactions:

0

Total no. in group:

9

Clinical observations:

not sensitising

Remarks on result:

no indication of skin sensitisation

Any other information on results incl. tables

Table 1:  Patch test results

 

Chemical	No of patients tested	?+	+	++
D&C Green 8 (2% in pet.)	9	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Conclusions:

The sensitization potential of D&C Green 8 was determined by performing patch tests on humans.
9 patients were tested with the dye. No reactions were reported by all the patients
D&C Green 8 can be considered as a non- sensitizer in humans.

Executive summary:

The sensitization potential of D&C Green 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

 9 patients were tested with the dye.No reactions were reported by all the patients

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