Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
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:
1976
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:
2003
Bibliographic source:
International Journal of Toxicology, 22(Suppl.3):1–108,2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
The allergenic potential of test chemical 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
Justification for non-LLNA method:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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 % of test chemical
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% test chemical
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 test chemical (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 group
Dose level:
0.02 ml of 0.1% of test chemical
No. with + reactions:
1
Total no. in group:
31
Clinical observations:
The test chemical did not develope any skin sensitizing effects on treated animals.
Remarks on result:
no indication of skin sensitisation

In vivo (LLNA)

Cellular proliferation data / Observations:
The test chemical did not develope any skin sensitizing effects on treated animals.

Applicant's summary and conclusion

Interpretation of results:
other: not sensitizing
Conclusions:
There was one positive reaction to test chemical in the skin test was observed out of 31 pateints.Hence, the test chemical can be considered to be not sensitizing to skin.
Executive summary:

The allergenic potential of test chemical 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 injection of 0.02 ml of 0.1% test chemical; the results were scored 20 min after dosing. There was one positive reaction to test chemical in the skin test was observed out of 31 patients. Hence, the test material can be considered to be not sensitizing to skin.