Registration Dossier
Registration Dossier
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EC number: 421-450-8 | CAS number: 154702-15-5
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September-October 1995
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD guideline for testing of chemicals (proposal for a new guideline, percutaneous absorption, in vitro method, drat document March 1994)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- -
- EC Number:
- 421-450-8
- EC Name:
- -
- Cas Number:
- 154702-15-5
- Molecular formula:
- C44H59N7O5
- IUPAC Name:
- 2-ethylhexyl 4-[(4-{[4-(tert-butylcarbamoyl)phenyl]amino}-6-[(4-{[(2-ethylhexyl)oxy]carbonyl}phenyl)amino]-1,3,5-triazin-2-yl)amino]benzoate
- Details on test material:
- - Name of test material (as cited in study report): RA 3643
- Physical state: white powder
- Analytical purity:99%
- Lot/batch No.: 51/95
- Storage condition of test material: room temperature
Constituent 1
Results and discussion
Any other information on results incl. tables
Skin mean thickness of the skin organ cultures : 1.847 +/- 0.23 mm
Percutaneous absorption: after 24 h of exposure the % of absorption remained lower than 0.1% of the applied dose when test item was applied in oil-in-water emulsion or in isopropyl myristate. Percutaneous absorption was influenced only marginally by the vehicle. RA3643 was absorped slightly better when applied in oil-in-water emulsion comparedor to isopropyl myristate. No consistent dose-dependency of the absorption were observed. When was applied as powder no skin absorption was observed.
Percutaneous absorption rate after 24 h: between 0.0 and 4.90 nmole/cm^2/h
Percutaneous absorption rate in the control group: 160.46 nmole/cm^2/h
Percentage of RA3643 in the skin tissue after 24 h: between 0.26 and 1.54 % of the applied dose
Cytotoxicity : no statistically significant differences in LDH leakage was observed between the test group 24 h after application.No damage in exposed skin cultures was noted.
Applicant's summary and conclusion
- Conclusions:
- RA3643 did not induce toxicity in human skin cultures.
RA3643 showed in vitro a very low percutaneous absorption (less than 0.1% of the applied dose) and was found not to be toxic to hyman skin cultures.
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