6-aminonaphthalene-2-sulphonic acid

Skin sensitisation

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

Guideline:

other: as mentioned below

Principles of method if other than guideline:

A delayed contact hypersensitivity test was conducted on Guinea pigs to evaluate the skin sensitization potential of test chemical under occlusive condition.

GLP compliance:

not specified

Type of study:

other: delayed contact hypersensitivity

Justification for non-LLNA method:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

sodium naphthalene-2-sulfonate

Cas Number:

532-02-5

Molecular formula:

C10H8O3S.Na

IUPAC Name:

sodium naphthalene-2-sulfonate

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): SNS (sodium 2-naphthalenesulfonate)
- Molecular formula: C10H7NaO3S
- Molecular weight: 230.23 g/mol
- Substance type: Organic
- Physical state: solid
- 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

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

not specified

Study design: in vivo (non-LLNA)

Induction

Route:

epicutaneous, occlusive

Vehicle:

other: Petroleum jelly

Concentration / amount:

Induction exposure:
Amount : 500 mg (0.5 g)
Concentration: 30% (w/w)

Day(s)/duration:

3 weeks.

Adequacy of induction:

not specified

Challenge

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

other: Petroleum jelly

Concentration / amount:

Challenge exposure:
Amount : 100 mg (0.1 g)
Concentration: 30%, 10%, 3% (w/w)

Day(s)/duration:

48 hours

Adequacy of challenge:

not specified

No. of animals per dose:

Total 20
control group:10
test group: 10

Details on study design:

RANGE FINDING TESTS:

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:3
- Exposure period: 6 hour
- Test groups: Ten animals
- Control group: Ten animals
- Site: clipped and shaved Flank
- Frequency of applications: Once a week
- Duration: 3 weeks.
- Concentrations: Amount : 500 mg (0.5 g)
Concentration: 30% (w/w)



B. CHALLENGE EXPOSURE
- No. of exposures: one time
- Day(s) of challenge: after two weeks
- Exposure period: 24 h
- Test groups: Ten animals
- Control group: Ten animals
- Site: clipped and shaved Flank
- Concentrations: Amount : 100 mg (0.1 g)
Concentration: 30%, 10%, 3% (w/w)

- Evaluation (hr after challenge): 24 and 48 h

Other: Skin reactions were scored on a −, ±, +, ++, +++ scale at 24 and 48 h.

Challenge controls:

Yes concurrent vehicle.

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:

30%, 10%, 3% (w/w) (100 mg)

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

In no case was there a positive response.

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

other: not sensitising

Conclusions:

None of the treated animal showed any signs of delayed contact hypersensitivity within 48 hours. Thus, the test chemical was considered to be not sensitizing in Guinea pigs.
 

Executive summary:

A delayed contact hypersensitivity test was conducted on Guinea pigs to evaluate the skin sensitization potential of test chemical under occlusive condition.

 

Ten animals were used in the treatment group and 10 in the control group.during induction, the test site on the flank was clipped and shaved and 500mg (0.5 g) of the 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. Skin reactions were scored on a −, ±, +, ++, +++ scale at 24 and 48 h.

 

None of the treated animal showed any signs of delayed contact hypersensitivity within 48 hours. Thus, the test chemical was considered to be not sensitizing in Guinea pigs.