Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: toxicokinetic information derived from other studies
Adequacy of study:
supporting study
Study period:
2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Overview based on existing toxicity data.

Data source

Reference
Reference Type:
other: Compilation of available data.
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Principles of method if other than guideline:
Overview based on existing toxicity data.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
melam
IUPAC Name:
melam

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no bioaccumulation potential based on study results
Executive summary:

The toxicokinetic behaviour of melam was estimated from available data for the purpose of registration of the substance.

Absorption, distribution: No systemic effects were observed in the acute oral toxicity studies even at high doses. No toxic effects were detected in the repeated dose toxicity tests, too. Only unspecific, possibly systemic effects (reduced body weight gain of the dams) were detected in the teratogenicity studies at high doses of 1000 mg/kg bw. Therefore it is concluded that an absorption after peroral administration of the submitted substance might have occurred, at least at high doses. No information on the distribution was obtained, as only unspecific effects were noted.

The logPow is very low and does not favour an oral or an inhalation absorption of the substance. Also the molecular mass of 235 does not point to a good absorption.

Metabolism: No relevant differences occurred in the mutagenicity studies with and without the addition of a metabolising system. Therefore no indication of the importance of the metabolism of the test substance was obtained from these studies.

Bioaccumulation: A potential for bioaccumulation is unlikely, based on the low partition coefficient. No statement on the bioaccumulation can be derived from the comparison of the effective doses in the acute and the repeated dose oral toxicity study.

Excretion: No relevant data are available, which provide evidence on the route of excretion.