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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study summarised in peer-reviewed paper.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1976
Reference Type:
review article or handbook
Title:
Fragrance material review on methyl salicylate
Author:
Lapczynski A, Jones L, McGinty D et al
Year:
2007
Bibliographic source:
Food Chem Toxicol 45:S428-S452

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline required
Principles of method if other than guideline:
Human maximization procedure
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
not specified
Subjects:
25 volunteers
Route of administration:
dermal

Results and discussion

Results of examinations:
SYMPTOMS
- Frequency, level, duration of symptoms observed: No evidence of sensitization

Applicant's summary and conclusion

Conclusions:
The incidence of positive reactions in patients with existing dermatitis was low . The highest incidence (3%) was seen in a study of 585 eczema patients. In two large studies (3109 and 1825 allergy patients), the incidence of positive reactions was lower (0.19% and 0.4%).
Executive summary:

In a review of MeS as a fragrance ingredient (Lapczynski et al, 2007), summaries are reported of 12 publications describing diagnostic studies on dermatitis patients, using several internationally-approved patch testing protocols. The test concentration of MeS was generally 2% in petrolatum.

The incidence of positive reactions in patients with existing dermatitis was low . The highest incidence (3%) was seen in a study of 585 eczema patients. In two large studies (3109 and 1825 allergy patients), the incidence of positive reactions was lower (0.19% and 0.4%).