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Toxicological information

Specific investigations: other studies

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specific investigations: other studies
Adequacy of study:
other information

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Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Principles of method if other than guideline:
Test procedure:
Not applicable.

Results and discussion

Details on results:
Administration of samples of undiluted DEMB and of any of
the dilutions (i.e. 200 and/or 10 mg/ml in propylene glycol)
on freshly prepared non-living animal skin via open or
occlusive application, did not result in any
physico-chemical reaction i.e. the substance did not catch
fire.


After open application, no biological reactions in the skin
were observed in response to the three concentrations used.
The white discolouration, noted during the observation
period, after exposure to the undiluted test substance is an
optical effect likely due to (rapid) evaporation and not
related to a biological effect in the skin-tissue.



Occlusive administration of the undiluted test substance for
2 hours to a sacrificed, intact guinea pig, caused
corrosion of the skin as observed after removal of the
bandages.

The skin-site treated with a 200 mg/ml solution showed
novisible changes as assessed in situ. After excision of the
treated skin, slight effects, a yellowish discolouration of
the subcutis, were observed with a 200 mg/ml solution.



The intradermal injections of different concentrations made
in the guinea pig showed a dose-response relationship as a
gradual increase of the diameter of necrosis with increasing
concentrations. At higher concentrations the maximum
diameter of the necrosis was found within 15 minutes after
treatment. An increase of the diameter of necrosis after
injection of a 10 mg/ml was observed from < 3 mm after 15
minutes to >= 5 mm after 2 hours.

Applicant's summary and conclusion