Sodium salicylate

Skin sensitisation

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 journal.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Clinical and immunological studies.

Author:

Patriarca et al.

Year:

1976

Bibliographic source:

Z. Immun.-Forsch

Reference 2

Reference Type:

publication

Title:

Safety Assessment - Test chemical

Author:

COSMETIC INGREDIENT REVIEW

Year:

2003

Bibliographic source:

International Journal of Toxicology

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 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

Test material information

Constituent 1

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: 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

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 test chemical

No. with + reactions:

1

Total no. in group:

31

Clinical observations:

The test chemical did not develop any skin sensitizing effects on treated animals.

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 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.