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Toxicological information

Epidemiological data

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Administrative data

Endpoint:
epidemiological data
Type of information:
other: Epidemiological study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Contact sensitization to Euxyl K400
Author:
Bordel-Gómez, M.T. and Miranda-Romero, A.
Year:
2009
Bibliographic source:
Actas Dermosifilográficas 100, 201-4

Materials and methods

Study type:
other: retrospective study
Endpoint addressed:
skin sensitisation
Principles of method if other than guideline:
Retrospective analysis of medical records
GLP compliance:
no
Remarks:
not applicable

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2-Phenoxyethanol
- Analytical purity: no data

Method

Type of population:
other: patients attended in a skin allergy unit
Details on study design:
HYPOTHESIS TESTED: Prevalence of sensitisation


METHOD OF DATA COLLECTION
- Type: Record review


STUDY POPULATION
- Total population: 1092
- Selection criteria: Patch test-treated patients
- Sex/age/race: 61,6 % women/41.8 ± 16.1 years/not specified


HEALTH EFFECTS STUDIED
- Disease(s): Prevalence of sensitisation
Exposure assessment:
not specified
Statistical methods:
Statistical analysis was done by means of contingency tables using Pearson's chi-square test for categorical variables and Fisher's Student's t-test for quantitative variables. Agreement between sensitisation to Euxyl K400 and it components was calculated by means of contingency tables using the Kappa ponderate index (Kp).

Results and discussion

Results:
Only 15 patients developed a positive reaction to Euxyl K400 (consisting of MDGN and 2 -Phenoxyethanol in a proportion of 1 to 4). Of these, 11 were positive to MDGN and 2 to phenoxyethanol. Sensitisation was more common in men. The agreement between sensitisation to Euxyl K400 and MDGN was good (Kp = 0.68), whereas agreement between Euxyl K400 and phenoxyethanol was poor (Kp = 0.23).

Applicant's summary and conclusion