Sodium naphthalene-2-sulphonate

Eye irritation

Administrative data

Endpoint:

eye 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.

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

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.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

No data available

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1 ml (approximately 64 mg) of SNS was placed into the conjunctival sac of the right eye.

Duration of treatment / exposure:

7 days

Observation period (in vivo):

1, 24, 48, and 72 h. Additional observations were made on days 5 and 7 to assess the reversibility of any ocular effects.

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 7 days

Reversibility:

not specified

Remarks on result:

other: Areas of translucent corneal opacity persisted in one treated eye at the day 5 observation. Sloughing of the cornea was noted in one treated eye at day 5, but the other two animals’ eyes returned to normal at day 7

Irritant / corrosive response data:

For the conjunctivae, redness, chemosis, and discharge were determined and for the cornea, degree of opacity and area of opacity were determined. Any damage to the iris was noted. Assessments were made at 1, 24, 48, and 72 h. Additional observations were made on days 5 and 7 to assess the reversibility of any ocular effects. Areas of diffuse corneal opacity were noted in all treated eyes at 1 and 24 h, which lessened at 48 and 72 h.

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Sodium 2-naphthalenesulfonate was found to be moderate irritant to rabbit eye

Executive summary:

In eye irritation study three New Zealand white rabbits was observed for Sodium 2-naphthalenesulfonate. One drop of local anesthetic was instilled into both eyes at 3-min intervals over a period of 15-min before treatment. A volume of 0.1 ml (approximately 64 mg) of SNS was placed into the conjunctival sac of the right eye. For the conjunctivae, redness, chemosis, and discharge were determined and for the cornea, degree of opacity and area of opacity were determined. Any damage to the iris was noted. Assessments were made at 1, 24, 48, and 72 h. Additional observations were made on days 5 and 7 to assess the reversibility of any ocular effects. Areas of diffuse corneal opacity were noted in all treatedeyes at 1 and 24 h, which lessened at 48 and 72 h. Areas of translucent corneal opacity persisted in one treated eye at the day 5 observation. Sloughing of the cornea was noted in one treated eye at day 5, but the other two animals’ eyes returned to normal at day 7.The authors concluded that (SNS)Sodium 2-naphthalenesulfonatewas at least a moderate irritant to the rabbit eye. Because one rabbit showed irreversible ocular damage, the test material was viewed as corrosive to the eye