Registration Dossier
Registration Dossier
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EC number: 222-695-1 | CAS number: 3576-88-3
Basic toxicokinetics
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:
- 2 011
- Report date:
- 2011
Materials and methods
- Principles of method if other than guideline:
- Overview based on existing toxicity data.
- GLP compliance:
- no
Test material
- Reference substance name:
- melam
- IUPAC Name:
- melam
Constituent 1
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.
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