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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
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 method is accepatble. Also data is from relaible sources which confirm the classfication of the substance.

Test material

Constituent 1
Chemical structure
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
Test material form:
solid: particulate/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 : 524.385088 g/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
Specific details on test material used for the study:
Name of test material (as cited in study report): Solvent Green 7 also known as Pyranine
Common Name: D&C Green 8
Molecular formula : C16H10O10S3.3Na
Molecular weight : 524.385088 g/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:
other: humans
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Source: test results of persons tested in author's practice

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2% pet.
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2% pet.
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
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
168
Group:
test chemical
Dose level:
2% in pet.
No. with + reactions:
0
Total no. in group:
9
Clinical observations:
no dermal reactions noted
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:
other: not sensitizing
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.