Registration Dossier
Registration Dossier
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EC number: 225-208-0 | CAS number: 4719-04-4
Epidemiological data
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:
- 2 011
- 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 substance name:
- 2,2',2''-(hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol
- EC Number:
- 225-208-0
- EC Name:
- 2,2',2''-(hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol
- Cas Number:
- 4719-04-4
- Molecular formula:
- C9H21N3O3
- IUPAC Name:
- 2,2',2''-(1,3,5-triazinane-1,3,5-triyl)triethanol
Constituent 1
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
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