Registration Dossier
Registration Dossier
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EC number: 400-820-2 | CAS number: 84268-33-7
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliance, not OECD guideline
Data source
Reference
- Reference Type:
- other: inquiry result from ECHA
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 400-820-2
- EC Name:
- -
- Cas Number:
- 84268-33-7
- Molecular formula:
- C20H23N3O3
- IUPAC Name:
- methyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate
- Details on test material:
- Details of label:
14C-labelled substance. Label is in the phenolic ring.
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- other: Rta (Wistar)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Suspension in a mixture of acetone, Cremphor and 0.9% NaCl.
- Details on exposure:
- Method of administration or exposure: Gavage
- No. of animals per sex per dose / concentration:
- Male: 5 animals at 1 mg/kg
Male: 5 animals at 10 mg/kg
Female: 5 animals at 1 mg/kg
Female: 5 animals at 10 mg/kg
Results and discussion
Any other information on results incl. tables
Very similar excretion patterns were observed in both sexes at both dose levels. Most of the radioactivity was rapidly recovered in the faeces (within 24 hours), and after 168 hours accounted for 92-97% of the administered dose. Urinary excretion was also rapid, being virtually complete within 24 hours. Based on urinary excretion, low but significant amounts of test substance were absorbed from the gastro-intestinal tract (at leastabout 5-9% of administered dose). Additionally, the low or negligible levels of radioactivity found at 168 hours in organs/tissue (including liver), blood/plasma, intestinal tract and residual carcass reflect the highly efficient excretion of the test substance in both sexes at both dose levels.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
