Sodium naphthalene-2-sulphonate

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

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

Guideline:

other: as below

Principles of method if other than guideline:

To evaluate the skin sensitization property of Sodium 2-naphthalenesulfonate in Guinea pigs.

GLP compliance:

not specified

Type of study:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sodium naphthalene-2-sulphonate

EC Number:

208-523-8

EC Name:

Sodium naphthalene-2-sulphonate

Cas Number:

532-02-5

Molecular formula:

C10H8O3S.Na

IUPAC Name:

sodium naphthalene-2-sulphonate

Constituent 2

Reference substance name:

Sodium 2-naphthalenesulfonate

IUPAC Name:

Sodium 2-naphthalenesulfonate

Details on test material:

Details on test material
- Name of test material (as cited in study report): sodium 2-naphthalenesulfonate
- Molecular formula (if other than submission substance): C10H8O3S.Na
- Molecular weight (if other than submission substance): 230.23 g/mol
- Substance type: Organic
- Physical state: No data available.
Purity
- 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

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

other: Petroleum jelly

Induction 2

Concentration / amount:

Induction exposure: 0.5 g of SNS at a concentration of 30% (w/w) diluted in petroleum jelly.
Challenge exposure: 0.1 g of SNS at a concentration each of 30%, 10%, 3% (w/w) diluted in the petroleum jelly.

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

other: Petroleum jelly

Challenge 2

Concentration / amount:

Induction exposure: 0.5 g of SNS at a concentration of 30% (w/w) diluted in petroleum jelly.
Challenge exposure: 0.1 g of SNS at a concentration each of 30%, 10%, 3% (w/w) diluted in the petroleum jelly.

No. of animals per dose:

Induction exposure: 10 animals
Challenge exposure: 10 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:

No data available.

Positive control substance(s):

not specified

Results and discussion

In vivo (non-LLNA)

Results

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.1 g of SNS at a concentration each of 30%, 10%, 3% (w/w) diluted in the petroleum jelly

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

No response

Remarks on result:

other: see Remark

Remarks:

Reading: 1st reading. . Hours after challenge: 48.0. 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. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No response.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Sodium 2-naphthalenesulfonate was found to be not sensitizing in Guinea pigs

Executive summary:

Skin sensitization was observed for Sodium 2-naphthalenesulfonate 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 of SNS 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. Skin reactions were scored on a −, ±, +, ++, +++ scale at 24 and 48 h. In no case was there a positive response, leading the authors to conclude that SNS has no potential to induce delayed contact hypersensitivity.