Registration Dossier

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:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

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.