Registration Dossier
Registration Dossier
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EC number: 226-408-0 | CAS number: 5395-50-6
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- 2013
- 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
- Principles of method if other than guideline:
- - Principle of test: dermal absorption study
- Short description of test conditions: topical treatment of rats with 3 % 14C-labelled test substance for 6 hours
- Parameters analysed / observed: stratum corneum, deeper skin, faeces, urine, blood, organs, tissues - GLP compliance:
- not specified
Test material
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Duration of exposure:
- 6 hours
- Doses:
- 3 %
Results and discussion
- Signs and symptoms of toxicity:
- not specified
- Dermal irritation:
- not specified
- Absorption in different matrices:
- 1 - 4 % of the test substance was found in the stratum corneum after 6 hours
0.4 - 3 % of the dose had penetrated the deeper skin at this time point
0.04 % of the absorbed material was excreted in faeces and 0.3 % was excreted in urine
Applicant's summary and conclusion
- Conclusions:
- Topical treatment of rats with 3 % 14C-labelled test substance for 6 hours resulted in 87 % of the total dose remaining unabsorbed.
- Executive summary:
A dermal absorption study indicated poor dermal availability of the test substance. Topical treatment of rats with 3 % 14C-labelled test substance for 6 hours resulted in 87 % of the total dose remaining unabsorbed. Only 1 - 4 % of the test substance was found in the stratum corneum after 6 hours, and 0.4 - 3 % of the dose had penetrated the deeper skin at this time point. Of the absorbed material, 0.04 % was excreted in faeces and 0.3 % was excreted in urine. The radioactivity detected in blood, organs and tissues was negligible after 6 and 24 hours, with no radioactivity detected after 48 hours.
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