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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
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 Naphthalenesulfonate salts
Author:
Cosmetic Ingredient Review Expert Panel
Year:
2003
Bibliographic source:
International Journal of Toxicology, 2003

Materials and methods

Test guideline
Qualifier:
according to
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
GLP compliance:
not specified
Type of study:
other: delayed contact hypersensitivity
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Scoring Pattern:
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 group
Dose level:
30%, 10%, 3% (w/w) (100 mg)
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None of the treated animal showed delayed contact hypersensitivity within 48 hours
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
None of the treated animal showed delayed contact hypersensitivity within 48 hours

Applicant's summary and conclusion

Interpretation of results:
other: not sensitising
Conclusions:
None of the treated animal showed delayed contact hypersensitivity within 48 hours. Thus, the 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 30% (w/w) test chemical 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 delayed contact hypersensitivity within 48 hours. Thus, the chemical was considered to be not sensitizing in Guinea pigs.