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Administrative data

Description of key information

In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the skin sensitization potential was estimated for Disodium 4-hydroxynaphthalene-2,7-disulphonate. It was estimated that Disodium 4-hydroxynaphthalene-2,7-disulphonatew as not sensitizing to guinea pig 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:
(Q)SAR
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification
Justification for type of information:
Data is predicted using OECD QSAR toolbox version 3.4 and QMRF report has been attached
Qualifier:
according to guideline
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Prediction was done by using OECD QSAR toolbox v3.4,2017
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Specific details on test material used for the study:
- Name of test material: Disodium 4-hydroxynaphthalene-2,7-disulphonate
- Common name: 2,7-Naphthalenedisulfonic acid, 4-hydroxy-, sodium salt (1:2)
- Molecular formula: C10H6Na2O7S2
- Molecular weight: 348.2624 g/mol
- Smiles notation: c1cc2c(cc1S(=O)(=O)[O-])cc(cc2O)S(=O)(=O)[O-].[Na+].[Na+]
- InChl: 1S/C10H8O7S2.2Na/c11-10-5-8(19(15,16)17)4-6-3-7(18(12,13)14)1-2-9(6)10;;/h1-5,11H,(H,12,13,14)(H,15,16,17);;/q;2*+1/p-2
- Substance type: Organic
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
Not specified
Day(s)/duration:
not specified
Adequacy of induction:
not specified
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
not specified
Concentration / amount:
Not specified
Day(s)/duration:
Not specified
Adequacy of challenge:
not specified
No. of animals per dose:
Not specified
Details on study design:
No data available
Challenge controls:
Not specified
Positive control substance(s):
not specified
Reading:
1st reading
Group:
test chemical
Dose level:
Not specified
Clinical observations:
no skin reaction
Remarks on result:
no indication of skin sensitisation
Cellular proliferation data / Observations:
no indication of skin reaction

The prediction was based on dataset comprised from the following descriptors: "Skin Sensitisation"
Estimation method: Takes highest mode value from the 6 nearest neighbours
Domain  logical expression:Result: In Domain

((((((("a" or "b" )  and ("c" and ( not "d") )  )  and "e" )  and ("f" and ( not "g") )  )  and "h" )  and "i" )  and ("j" and "k" )  )

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as Strong binder, OH group by Estrogen Receptor Binding

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as Acid moiety AND Phenols AND Salt by Aquatic toxicity classification by ECOSAR

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Not possible to classify according to these rules (GSH) by Protein binding potency

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as Moderately reactive (GSH) OR Moderately reactive (GSH) >> 2-Vinyl carboxamides (MA) OR Moderately reactive (GSH) >> Vinyl bromides (SN2) by Protein binding potency

Domain logical expression index: "e"

Referential boundary: The target chemical should be classified as High (Class III) by Toxic hazard classification by Cramer (original) ONLY

Domain logical expression index: "f"

Referential boundary: The target chemical should be classified as Group 1 - Alkali Earth Li,Na,K,Rb,Cs,Fr AND Group 14 - Carbon C AND Group 16 - Oxygen O AND Group 16 - Sulfur S by Chemical elements

Domain logical expression index: "g"

Referential boundary: The target chemical should be classified as Group 17 - Halogens Cl by Chemical elements

Domain logical expression index: "h"

Similarity boundary:Target: Oc1cc(S(=O)(=O)O{-}.[Na]{+})cc2cc(S(=O)(=O)O{-}.[Na]{+})ccc12
Threshold=30%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization

Domain logical expression index: "i"

Similarity boundary:Target: Oc1cc(S(=O)(=O)O{-}.[Na]{+})cc2cc(S(=O)(=O)O{-}.[Na]{+})ccc12
Threshold=40%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization

Domain logical expression index: "j"

Parametric boundary:The target chemical should have a value of log Kow which is >= -4.13

Domain logical expression index: "k"

Parametric boundary:The target chemical should have a value of log Kow which is <= -1.01

Interpretation of results:
other: Negative
Conclusions:
Disodium 4-hydroxynaphthalene-2,7-disulphonate is considered to be non skin sensitizing on guinea pig skin
Executive summary:

In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the skin sensitization potential was estimated for Disodium 4-hydroxynaphthalene-2,7-disulphonate. It was estimated that Disodium 4-hydroxynaphthalene-2,7-disulphonatew as not sensitizing to guinea pig skin .

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

Skin sensitization:

In different studies, 2,7-Naphthalenedisulfonic acid, 4-hydroxy-, sodium salt (1:2) has been investigated for potential for skin sensitization to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with human data for target chemical and its structurally similar read across substances Trisodium 8-hydroxypyrene-1,3,6-trisulphonate (6358-69-6) and  Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (4548-53-2) .The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.

In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the skin sensitization potential was estimated for Disodium 4-hydroxynaphthalene-2,7-disulphonate. It was estimated that Disodium 4-hydroxynaphthalene-2,7-disulphonatew as not sensitizing to guinea pig skin .

The above results are further supported by the experimental study conducted by Contact Dermatitis 2003: 49: 217–218 for the structurally similar read across substance Trisodium 8-hydroxypyrene-1,3,6-trisulphonate (6358-69-6) common name (D&C Green 8 ) .

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.

The above result was supported by experimental study conducted by Commission of the European Communities reports of the Scientific Committee on Cosmetology (seventh series), 1988 for its structurally similar read across substances Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (4548-53-2)

Kligman maximisation test was conducted on chemical Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (4548 -53 -2). 25 healthy adults were exposed to concentration up to 0.3% (0.3 gm) in petrolatum and applied under occlusion for 48-hrs was negative.Hence,Non-sensitising effects was considered in Kligman maximisation test of chemical Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate exposed to 25 human adults for 48-hrs.

Based on the available data for the target as well as it read across substances,it can be concluded that 2,7-Naphthalenedisulfonic acid, 4-hydroxy-, sodium salt (1:2)  was not sensitizing to skin; and itcan be classified under the category “Not Classified” as per CLP regulation.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data for the target as well as it read across substances,it can be concluded that 2,7-Naphthalenedisulfonic acid, 4-hydroxy-, sodium salt (1:2)  was not sensitizing to skin; and it can be classified under the category “Not Classified” as per CLP regulation.