Registration Dossier
Registration Dossier
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EC number: 209-421-6 | CAS number: 578-36-9
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- 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
Reference
- Reference Type:
- publication
- Title:
- Allergic Contact Dermatitis from Ethylhexyl Salicylate and Other Salicylates
- Author:
- Charlotte Gotthard Mortz, Henrik Thormann, An Goossens, and Klaus Ejner Andersen
- Year:
- 2 010
- Bibliographic source:
- Dermatitis, 21, no. 2 (2010): E7-E10
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Patch test
- Principles of method if other than guideline:
- Patch test were conducted on a patient with allergic contact dermatitis to sunscreen
- GLP compliance:
- not specified
- Remarks:
- Study data from handbook or collection of data
- Type of study:
- patch test
- Justification for non-LLNA method:
- not specified
Test material
- Reference substance name:
- Sodium salicylate
- EC Number:
- 200-198-0
- EC Name:
- Sodium salicylate
- Cas Number:
- 54-21-7
- Molecular formula:
- C7H6O3.Na
- IUPAC Name:
- sodium salicylate
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report):sodium salicylate- Molecular formula :C7H6O3.Na- Molecular weight : 160.1035 g/mol- Substance type: organic- Physical state: solid- Smilies 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
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: 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
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2% in petrolatum
- No. with + reactions:
- 0
- Total no. in group:
- 1
- Clinical observations:
- no signs of sensitization observed
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
Table: Patch test results
Test compound |
CAS |
Test concentration |
Function |
Day 3 reading** |
Day 7 reading** |
Sodium salicylate |
54-21-7 |
2% in petrolatum |
Denaturant and preservative |
- |
- |
**-readings are for the patient in the case report
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- No dermal reactions were observed on day 3 and day 7 of observation when the patient was tested with 2% sodium salicylate in petrolatum.Hence, sodium salicylate can be considered to be not sensitizing to skin.
- Executive summary:
Patch test were conducted on a patient with allergic contact dermatitis to sunscreen.
A 48 year old woman with a 12 year history of rosacea was advised to use sunscreen. A sample of Anthelios dermo-pediatrics SPF-50+ was given to the patient. Half year later, the patient developed facial dermatitis. She was tested with the European baseline series using panels 1,2, and 3 of the Thin Layer Rapid Use Epicutaneous Test [T.R.U.E Test] supplemented petrolatum-based allergens in Finn chambers on Scanpor tape and with her own topical products including the Anthelios dermo-pediatrics SPF-50+ lotion. The tests were occluded for 2 days and read according to the ICDRG[International Contact Dermatitis Research Group]scoring scale on day 3 and day 7.
The patient was subsequently patch test with individual components of the Anthelios dermo-pediatrics SPF-50+ lotion as provided by the manufacturer.
No dermal reactions were observed on day 3 and day 7 of observation when the patient was tested with 2% sodium salicylate in petrolatum.
Hence, sodium salicylate can be considered to be not sensitizing to skin.
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