Registration Dossier
Registration Dossier
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EC number: 200-068-3 | CAS number: 50-85-1
Skin sensitisation
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 journals
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Intolerance to aspirin: Clinical and immunological studies.
- Author:
- Patriarca, G., A. Venuti, D. Schiavino, and G. Fais
- Year:
- 1 976
- Bibliographic source:
- Z. Immun.-Forsch. vol. 151, pp. 295-304 (1976)
- Reference Type:
- publication
- Title:
- Safety Assessment of Sodium Salicylate
- Author:
- American College of Toxicology
- Year:
- 2 003
- Bibliographic source:
- International Journal of Toxicology, 22(Suppl.3):1–108,2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- The allergenic potential of Sodium Salicylate was determined in a number of studies using up to 31 patients, 19 males and 12 females, with a history of aspirin intolerance
- GLP compliance:
- not specified
- Type of study:
- other: Intradermal Skin test
Test material
- Reference substance name:
- Sodium salicylate
- EC Number:
- 200-198-0
- EC Name:
- Sodium salicylate
- Cas Number:
- 54-21-7
- Molecular formula:
- C7H6O3Na
- IUPAC Name:
- sodium salicylate
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Sodium salicylate
- Molecular Formula: C7H6O3.Na
- Molecular Weight: 160.105 g/mol
- Smiles Notation: c1(c(cccc1)O)C(=O)[O-].[Na+]
- InChI: 1S/C7H6O3.Na/c8-6-4-2-1-3-5(6)7(9)10;/h1-4,8H,(H,9,10);/q;+1/p-1
- Substance Type: Organic
- Physical State: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Sodium salicylate
- Molecular Formula: C7H6O3.Na
- Molecular Weight: 160.105 g/mol
- Smiles Notation:
- InChI: 1S/C7H6O3.Na/c8-6-4-2-1-3-5(6)7(9)10;/h1-4,8H,(H,9,10);/q;+1/p-1
- Substance Type: Organic
- Physical State: Solid
In vivo test system
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Age: aged between 6 and 64 years
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- no data
- Concentration / amount:
- Induction exposure: 0.02 ml of 0.1 % sodium salicylate
- Day(s)/duration:
- 20 minutes
- Adequacy of induction:
- not specified
Challenge
- No.:
- #1
- Route:
- intradermal
- Vehicle:
- not specified
- Concentration / amount:
- an intradermal injection of 0.02 ml of 0.1% sodium salicylate
- Day(s)/duration:
- 20 minutes
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 19 males and 12 females
- Details on study design:
- an intradermal injection of 0.02 ml of sodium salicylate (0.1%) were given to human patients and the result were recorded after 20 min
- Challenge controls:
- no data available
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Vehicle:
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 20
- Group:
- test chemical
- Dose level:
- 0.02 ml of 0.1% of sodium salicylate
- No. with + reactions:
- 1
- Total no. in group:
- 31
- Clinical observations:
- Sodium salicylate is not skin sensitizing
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- There was one positive reaction to Sodium Salicylate in the skin test was observed out of 31 pateints.Hence, Sodium Salicylate can be considered to be not sensitizing to skin.
- Executive summary:
The allergenic potential of Sodium Salicylate was determined in a number of studies using up to 31 patients. 19 males and 12 females, with a history of aspirin intolerance were used for the assay. 31 patients were given an intradermal in injection of 0.02 ml of 0.1% Sodium Salicylate; the results were scored 20 min after dosing. There was one positive reaction to Sodium Salicylate in the skin test was observed out of 31 patients. Hence, Sodium Salicylate can be considered to be not sensitizing to skin.
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