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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
12/1995-03/1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Pre-guideline method, but data comprehensible and scientifically acceptable. (GLP: Yes) Bronaugh, R.L., R.F. Stewart and E. R. Congdon (1982) Methods for in vitro percutaneous absorption studies II. Animal Models for Human Skin Toxicology and Applied Pharmacology 62, 481-488
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

GLP compliance:
yes (incl. certificate)
Test type:
other: single 24 hours exposure skin penetration test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solution
Details on test material:
technical product

Test animals

Species:
pig

Results and discussion

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information
Conclusions:
The test article FLOVAN CGN was assessed for its potential to permeate through porcine skin.
The assay was performed in two independent experiments over a time scale of 0 to 24 hours. The test article was tested at the following concentration (a.i):
Experiment I and II: 0.94 mg/ml in water. Samples were drawn from the receptor chambers following a fixed schedule:
Exp. I and II: 0.0; 0.5; 1.0; 2.0; 4.0, 6.0; 8.0 and 24 hours following the application of the test article.
The samples (0.5 ml each) were labelled and transferred to the sponsor's facilities for subsequent analysis.

Specimens of a pig ear skin penetration study were separated by reversed phase HPLC follwed by UV-detection at 200 nm. The separated and detected FLOVAN
CGN a.i. was quantified by an external calibration function. The bottom quantification limit of the practical work amounted to 1.28 µg/mL FLOVAN CGN a.i. in aqueous solution. By means of a serial connection of two analytical HPLC-columns penetrated FLOVAN CGN a.i. in the specimens of the 24 h sampling interval were quantified. Within 24 hours less than 5 % (mean value) of the amount of FLOVAN CGN applied to the test system penetrated*. Within 8 hours no MPAAU were detected in the receptor chamber.

*) test substance applied to the test system: 212.44 µg FLOVAN CGN a.i.; 452.00 µg FLOVAN CGN
5 % of the test substance: 10.62 ug FLOVAN CGN a.i.; 22.60 ug FLOVAN CGN

Discussion: Since permeation of the test article through porcine skin was very low a graphical evaluation of the analytical data was impossible. The concentration of the permeated test article did not exceed the lower limit of detection prior to 8 hours after start of experiments.

In conclusion, it can be stated that FLOVAN CGN showed very low penetration through the skin of porcine ears. Within 8 hours no MPAAU were detected in the receptor chamber. Within 24 hours less than 5 % (mean value) of the amount of FLOVAN CGN applied to the test system penetrated.