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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 is from peer reviewed journal.

Data source

Reference
Reference Type:
publication
Title:
Final Report on the Amended Safety Assessment of Sodium Polynaphthalene sulfonate and Sodium Naphthalenesulfonate
Author:
Cosmetic Ingredient Review Expert Panel
Year:
2003
Bibliographic source:
International Journal of Toxicology, 22(Suppl. 2):37–44, 2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To evaluate the skin sensitization property of the given test chemical in Guinea pigs.
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):Sodium 2-naphthalenesulfonate
- Molecular formula :C10H7NaO3S
- Molecular weight :230.2183 g/mol
- Substance type:Organic
- Physical state: solid powder
-Smiles-c1ccc2cc(ccc2c1)S(=O)(=O)[O-].[Na+]
-InChI -1S/C10H8O3S.Na/c11-14(12,13)10-6-5-8-3-1-2-4-9(8)7-10;/h1-7H,(H,11,12,13);/q;+1/p-1
Specific details on test material used for the study:
- Name of test material (as cited in study report):Sodium 2-naphthalenesulfonate
- Molecular formula :C10H7NaO3S
- Molecular weight :230.2183 g/mol
- Substance type:Organic
-Physical state: solid powder
-Smiles-c1ccc2cc(ccc2c1)S(=O)(=O)[O-].[Na+]
-InChI -1S/C10H8O3S.Na/c11-14(12,13)10-6-5-8-3-1-2-4-9(8)7-10;/h1-7H,(H,11,12,13);/q;+1/p-1
- Impurities (identity and concentrations): Not more than 0.5% sulfate (as sodium sulfate); not more than 20 mg/kg of heavy metals; and not more than 2 mg/kg arsenic.

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data available.

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: Petroleum jelly
Concentration / amount:
0.5 g of SNS at a concentration of 30% (w/w) diluted in petroleum jelly.
Day(s)/duration:
3 weeks
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: Petroleum jelly
Concentration / amount:
0.1 g of SNS at a concentration each of 30%, 10%, 3% (w/w) diluted in the petroleum jelly.
Day(s)/duration:
2 weeks
Adequacy of challenge:
not specified
No. of animals per dose:
Ten animals
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:3 times
- Exposure period: 6 hour
- Test groups: Ten animals
- Control group: Ten animals
- Site: Flank
- Frequency of applications: Once a week
- Duration: 3 weeks.
- Concentrations: 0.5 g of SNS at a concentration of 30% (w/w) diluted in petroleum jelly.

B. CHALLENGE EXPOSURE
- No. of exposures: one time
- Day(s) of challenge: Two weeks
- Exposure period: 24 h
- Test groups: Ten animals
- Control group: Ten animals

- Site: Flank
- Concentrations: 0.1 g of SNS at a concentration each of 30%, 10%, 3% (w/w) diluted in the petroleum jelly.
- Evaluation (hr after challenge): 24 and 48 h

Challenge controls:
not specified
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
0.1 g of SNS at a concentration each of 30%, 10%, 3% (w/w) diluted in the petroleum jelly.
Total no. in group:
10
Clinical observations:
no skin reaction observed
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
other: not skin sensitizing
Conclusions:
The given test chemical when applied on on guinea pig‘s skin in the concentration 0.5 g in induction and 0.1 g in challenge produced no skin reaction. Hence, it was considered to be not sensitizing in Guinea pigs.
Executive summary:

Skin sensitization potential was observed for the given test chemical in Guinea pigs by delayed contact hypersensitivity reaction. Ten animals were in the treatment group and 10 in the control group. The test site on the flank was clipped and shaved and 0.5 g test chemical at a concentration of 30% (w/w) (diluted in petroleum jelly) was applied for 6 h under a closed patch, once a week, for 3 weeks. A control site received only the petroleum jelly. Two weeks after the last application, 0.1 g each of 30%, 10%, 3%, or the petroleum jelly were applied to the shaved skin and left for 24 h under a closed patch. The given test chemical when applied on guinea pigs skin in the concentration 0.5 g in induction and 0.1 g in challenge produced no skin reaction. Hence, it was considered to be not sensitizing in Guinea pigs.