Registration Dossier

Administrative data

Endpoint:
epidemiological data
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
2005 - 2009
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Patch testing with formaldehyde and formaldehyde-releasers: multicentre study in Spain (2005–2009)
Author:
Latorre N, Borrego L, Fernandez-Redondo V et al.
Year:
2011
Bibliographic source:
Contact Dermatitis, 65, 286–292

Materials and methods

Study type:
case control study (retrospective)
Endpoint addressed:
skin sensitisation
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
other: Patients who underwent patch testing during 2005-2009 in six Spanish hospitals.
Ethical approval:
not applicable
Details on study design:
METHOD OF DATA COLLECTION
- Type: Record review

STUDY PERIOD: 2005 - 2009

STUDY POPULATION
- Total population (Total no. of persons in cohort from which the subjects were drawn): 7838 (902 were treated with the test substance)
- Selection criteria: From all patients that underwent patch testing during 2005 and 2009 those were selected, who reacted positive on formaldehyde and specific formaldehyde releasers e.g. the test substance.

HEALTH EFFECTS STUDIED
- other health effects: skin reactions
Exposure assessment:
measured
Details on exposure:
TYPE OF EXPOSURE: Patch test with the test substance applied as 1 % solution in petrolatum.

Results and discussion

Results:
8 patients of 902 showed a positive skin reaction when treated with the test substance (0.88%).

Applicant's summary and conclusion