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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
Reason / purpose for cross-reference:
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

Constituent 1
Chemical structure
Reference substance name:
2-phenoxyethanol
EC Number:
204-589-7
EC Name:
2-phenoxyethanol
Cas Number:
122-99-6
Molecular formula:
C8H10O2
IUPAC Name:
2-phenoxyethan-1-ol
Specific details on test material used for the study:
- 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