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Toxicological information

Additional toxicological data

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Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The purity of the test substance was unknown. The protocols of the in vitro tests were very different from the standard method to evaluate the corrosivity but they were described in details and met the criteria agreed by the Management Team concerning acceptable underprediction and overprediction rates to be considered scientifically validated for use as replacement for the animal tests. The participating laboratories were selected according to their interest and proven competence in in vitro testing, taking into account the need for adherence to the principles of Good Laboratory practice (GLP) and for international participation. Within the context of the updated version of OECD testing guideline 404 (OECD, 1992), it was included the following statements: ".....it may not be necessary to test in vivo materials for which corrosive properties are predicted on the basis of results from in vitro tests". In this way, this study was interesting.

Data source

Reference
Reference Type:
publication
Title:
The ECVAM international validation study on in vitro tests for skin corrosivity. 2. Results and evaluation by the management team
Author:
Fentem J.H., Archer G.E.B., Balls M., Botham P.A., Curren R.D., Earl L.K., Esdaile D.J., Holzhutter H.-G., Liebsch M.
Year:
1998
Bibliographic source:
Toxicology in Vitro, 12, 483-524.

Materials and methods

Type of study / information:
In vitro tests for skin corrosivity

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
no data

Results and discussion

Any other information on results incl. tables

Using the TER assay, CORROSITEX assay and skin model ZK 1350, guaiacol was rated as "non-corrosive".
The EPISKIN assay, guaiacol was overclassified as R34 ("causes burns") and R35 ("causes severe burns") in the
prediction model A (a single treatment time of 240 min), and R34 in the prediction model B (three separate treatment times).
However, the authors concluded that the validities of TER and EPISKIN assays for discriminating corrosives from non-corrosives, and the EPISKIN assay for identifying correctly known R35 and R34 chemicals have been demonstrated
in this study.
The Skin ZK1530 did not meet the criteria for corrosive potential to be considered scientifically validated and also the CORROSITEX did not meet all of the criteria for it to be considered acceptable as a replacement test.

Applicant's summary and conclusion