Registration Dossier
Registration Dossier
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EC number: 226-408-0 | CAS number: 5395-50-6
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- publication
- Title:
- Human Health Tier II Assessment For N-Methylol imidazolidones
- Author:
- Accelerated Assessment of Industrial Chemicals in Australia (IMAP)
- Bibliographic source:
- https://www.nicnas.gov.au/chemical-information/imap-assessments
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- Commercially available allergen tests were applied to unaffected skin of the upper back.
Patches were removed after 2 days, and reactions graded on days 2, 3, and 7.
Test material
Constituent 1
Method
- Type of population:
- other: patients suspected of allergic contact dermatitis from clothing
- Subjects:
- Number of subjects: 103
- Clinical history:
- 9 of the later patch-positive pations has previously presented with purpuric allergic contact dermatitis.
- Route of administration:
- dermal
Results and discussion
- Results of examinations:
- 30 patients tested positive to any one allergen tested.
1 of the 9 of these patients with a history of purpurinic dermatitis was allergic to the registered substance. It is unknown, how many of the remaining 21 subjects patch tested positive to tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]i midazole-2,5(1H,3H)-dione.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
