Sodium naphthalene-2-sulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: 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 toxicity of Sodium naphthalene-beta-sulfonate in white rabbits by dermal application.

GLP compliance:

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

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report): SNS (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.

Test animals

Species:

rabbit

Strain:

other: Japanese albino rabbits

Details on test animals or test system and environmental conditions:

Sex: Female

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded and intact

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

Amount-0.5 g
Concentration applied-100% (undiluated)

Duration of treatment / exposure:

24 hour

Observation period:

3, 24, and 48 h

Number of animals:

Three

Details on study design:

TEST SITE
- Area of exposure: The test material was applied to abraded and intact skin at clipped sites on the animals’ backs.
- % coverage: 100%
- Type of wrap if used: Closed patch.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data available.
- Time after start of exposure:

CONTROL ANIMALS:
One abraded and one intact site received petroleum jelly.

SCORING SYSTEM: Reactions were scored for erythema and eschar formation on a scale of 0 to 4, and for edema on the same scale. A total score in the range of ≥5 to 8 was considered severely irritating; ≥2 to <5 was moderately irritating; >0 to <2 was mildly irritating; and a score of 0 was considered not irritating.

Results and discussion

In vivo

Results

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 3 hr

Score:

1

Max. score:

8

Reversibility:

no data

Remarks on result:

other: Mild irritant

Irritant / corrosive response data:

In only one animal, at the 3-h reading, was a grade 1 erythema seen with the undiluted material. No positive Erythema or edema scores were seen with the other animals exposed to undiluted SNS.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Sodium 2-naphthalenesulfonate was found to be mild irritant to rabbit skin when applied undiluted.

Executive summary:

In skin irritation study three female Japanese albinorabbitswere observed forSodium 2-naphthalenesulfonate toxicity. The test material was applied undiluted (0.5 g) to abraded and intact skin at clipped sites on the animals’ backs and a closed patch applied. After 24 h, the closed patch was removed, and the skin reactions were scored at 3, 24, and 48 h thereafter. In only one animal, at the 3-h reading, was a grade 1 erythema seen with the undiluted material. No positive Erythema or edema scores were seen with the other animals exposed to undiluted SNS. The authors concluded that SNS may be considered a mild irritant when applied undiluted.