Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Summary of available data
Adequacy of study:
key study
Reliability:
other: Expert statement

Data source

Materials and methods

Objective of study:
other: Assessment of toxicokinetic behaviour
Test guideline
Qualifier:
according to
Guideline:
other: Expert statement
Principles of method if other than guideline:
Assessment of toxicokinetic behaviour

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Expert statement, no test material needed

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: No toxicologically relevant observations were made in any study performed
The substance is toxicologically not relevant. It is not classified according to DSD and CLP criteria. In any toxicological study performed there is no concern raised.
Executive summary:

The substance has been tested for acute oral toxicity by
oral and dermal application, for 28-day toxicity by oral
application, for skin and eye irritation and for skin
sensitization. In addition, a screening test for toxicity to reproduction has been performed. Moreover, three in-vitro test for mutagenicity have been
performed, without any relevance for the toxicokinetic
behaviour of the substance.

In the test for the acute oral toxicity in rats, the
substance has been applied at dose levels of 2000 mg/kg body
weight and 5000 mg/kg body weight. No mortality could be
observed. No clinical signs, indicating a resorbtion and/or
toxicity of the substance, could be observed.

Dermal application of 2000 mg/kg body weight did not lead to
any mortality. No systemic effects could be observed that
would indicate any resorbtion and/or toxicity of the
substance.

In the skin and eye irritation study and in the skin
sensitization study, the application of the substance did
not lead to any systemic effects.

In the 28-day toxicity study in rats, the substance was
applied at dose levels of 50, 200 and 1000 mg/kg/day.

The dose levels in the screening study for toxicity to reproduction were 100, 300 and 1000 mg/kg/day.

No significant signs of systemic effects, indicating an
intestinal resorption, were observed.

Presumably, the substance was not resorbed or showed no
toxicity when resorbed.

All other available results do not lead to any indication of
the toxicokinetic behaviour of the substance.