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EC number: 401-680-5 | CAS number: 125304-04-3 TINUVIN 171; TINUVIN 571
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18.05.2006 - 10.07.2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Version / remarks:
- The study was based on partially fulfilling the requirements of the guideline
- Principles of method if other than guideline:
- The objective of this study was: To determine whether the test article is absorbed following oral administration.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- A mixture of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n=5 or 6
- EC Number:
- 401-680-5
- EC Name:
- A mixture of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n=5 or 6
- Cas Number:
- 125304-04-3
- Molecular formula:
- C25 H35 N3 O and C37 H59 N3 O
- IUPAC Name:
- Reaction mass of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol, branched and 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol, branched
Constituent 1
- Radiolabelling:
- yes
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: in-house, animals were received at the research laboratory
- Age at study initiation: males: ca. 6-7 weeks; females ca. 8-9 weeks
- Weight at study initiation: males: 187 - 225 g, females: 186-229 g
- Fasting period before study: no
- Housing: housed individually in glass metabolism cages (Metabowls)
- Individual metabolism cages: yes
- Diet: VRFI diet, ad libitum
- Water: from local water supply, ad libitum
- Acclimation period: at least 5 days prior to dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2
- Humidity (%): 55 +/- 15
- Air changes (per hr): approx. 15
- Photoperiod: 12 hrs dark / 12 hrs light
IN-LIFE DATES: 31.05. - 06.09.2006
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 4 % carboxymethylcellulose and 0.2 % Tween 80
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Dose formulations were freshly prepared for administration to groups of animals. Where required radiolabelled and non-radiolabelled test item were mixed together in ethyl acetate to achieve the desired specific activity for the dosed material. For all other dose groups, the radiolabelled test item was not radiodiluted. The solvent was removed under a stream of nitrogen and the solid material suspended in 2% (w/v) aqueous carboxymethylcellulose solution / 0.2% Tween 80, using a magnetic stirrer.
The quantity of radioactivity administered to each animal was determined from the weight of the administered formulation (based on the weight of the dosing syringe before and after dosing) and the measured concentration of radioactivity in the formulation. Further weighed portions of the dose formulation were either counted directly by LSC or dispensed into 20 or 25 mL volumetric flasks. These were made up to volume with methanol and triplicate aliquots of each solution taken for radioactivity measurement. The specific activity of the [14C]-test item in the high level formulation was calculated from the radioactivity concentration of the formulation (taking into account the specific activity of the undiluted test item) and the weight of non-radiolabelled test item in the formulation.
The nominal radioactivity contained in each dose (50 mg/kg groups) was 20 µCi per rat (200 g).
VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
HOMOGENEITY AND STABILITY OF TEST MATERIAL:
At least triplicate aliquots of each dose formulation were analyzed for radioactivity to confirm the homogeneity of the formulation and the actual dose level. The dose formulation were analyzed for stability of the test substance after dosing. - Duration and frequency of treatment / exposure:
- All animals received a single dose via oral gavage.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0.5 mg/kg bw/day
- Remarks:
- Group 1: Excretion/tissue distribution, sacrifice 168h
- Dose / conc.:
- 50 mg/kg bw/day
- Remarks:
- Group 2: Excretion/tissue distribution, sacrifice 168h
- Dose / conc.:
- 0.5 mg/kg bw/day
- Remarks:
- Group 3: Tissue distribution, sacrifice 6h
- Dose / conc.:
- 50 mg/kg bw/day
- Remarks:
- Group 4: Tissue distribution, sacrifice 6h
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- no
- Positive control reference chemical:
- None
- Details on study design:
- - Dose selection rationale: Dose levels have been selected after consultation with the appropriate Regulatory Authority, the BfR, and have been set at levels which would cause no observable effects (NOEL).
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, cage wash, faeces, plasma, whole-blood, fat, muscle, brain, heart, kidney, liver, lungs, spleen, testes, ovaries, uterus, gastrointestinal tract, carcass
- Time and frequency of sampling:
urine: 0-6, 6-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168 hrs after administration
faeces: 0-24, 24-48,48-72, 72-96, 96-120, 120-144, 144-168 hours after administration
volatiles: 0-24 hrs after the administration
all others: 168 hrs after administration - Statistics:
- The mean and standard deviation were used to characterise the data, where appropriate (i.e., radioactivity measurement, concentrations, etc.). Concentrations of radioactivity in blood, plasma and tissues were calculated as µg equivalents of test item/g of sample. The total amounts of radioactivity in tissue and excreta samples were calculated as a percentage of the administered radioactivity and a 14C mass balance is presented. Individual excretion half-lives (t ½) were calculated by linear regression of time versus log concentration curves for urine and faeces.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- Absorption based on values in urine, expired air and tissues was low.
- Type:
- distribution
- Results:
- After 6hrs (high and low dose level): liver > spleen > ovaries > all others; after 168 hrs (high and low dose level): ovaries > liver > fat > all others
- Type:
- excretion
- Results:
- Mainly via faeces and in a lower extend via urine and negligibly via expired air.
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Absorption values in urine, expired air and tissues was low (1-3 % dose).
- Details on distribution in tissues:
- - 168 hours
0.5 mg/kg bw and 50 mg/kg bw test item:
Following administration of [phenyl-14C]-test item, very little of the administered radioactivity (< 1 %) was retained in the tissues at 168 hours. The highest accumulation occurred in the ovaries, liver and fat. There was less than a proportional increase in tissue concentrations of radioactivity at the high dose level.
- 6 hours
0.5 mg/kg bw test item:
Following administration of [phenyl-14C]-test item at 0.5 mg/kg bw (low level), a mean of less than 8 % administered radioactivity was retained in the tissues other than gastrointestinal tract (including contents) at 6 hours. Most of the retained radioactivity was detected in the liver (7 % dose). The highest concentrations occurred in the liver, spleen and ovaries.
50 mg/kg bw test item:
At 6 hours following administration of [phenyl-14C]-test item at 50 mg/kg bw (high level), a mean of 3 % administered radioactivity was retained in the tissues other than gastrointestinal tract and contents. Most of the retained radioactivity was detected in the liver (3 % dose). The highest concentrations occurred in the liver, spleen and ovaries.
- Details on excretion:
- After administration of [14C]-test item at the low and high dose levels, < 1 % dose was excreted in the urine and 93 - 96 % was excreted in the faeces. More than 77 % dose was excreted in the faeces during 0 - 24 hours after dose administration. Most of the radioactivity (>90 %) was excreted within the first 48 hours after administration.
Metabolite characterisation studies
- Metabolites identified:
- not measured
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.
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