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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13.05. - 29.07.1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- but performed under GLP-like quality control with QAU statement included.
- Type of assay:
- micronucleus assay
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
- Details on test material:
- - Appearance: yellow liquid
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- hamster, Chinese
- Strain:
- other: random outbred strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Tierfarm, Sisseln
- Age at study initiation: females: 6-10 weeks; males: 4-9 weeks
- Weight at study initiation: females 22-35 g, males 23-35 g (tolerability test), females 28-34 g, males 28-33 g (mutagenicity test)
- Assigned to test groups randomly: no data
- Fasting period before study: no data
- Housing: not specified
- Diet: standard diet NAFAG No.924, ad libitum
- Water: tap water, ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-23
- Humidity (%): 52-56
- Air changes: no data
- Photoperiod: 12 hrs dark /12 hrs light
IN-LIFE DATES: from 24.02. - 13.05.1986
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle/solvent used: arachis oil
- Amount of vehicle (if gavage or dermal): 10 ml/kg bw - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test item was formulated in arachis oil. - Duration of treatment / exposure:
- Single treatment.
- Frequency of treatment:
- The animals received the test item, the vehicle or the positive control substance once. The dosing volume was 10 mL/kg bw.
- Post exposure period:
- 16 h, 24 h or 48 h
Doses / concentrations
- Dose / conc.:
- 5 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 24 at 5000 mg/kg and for negative control (8 per sampling time).
8 for positive control. - Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
- Justification for choice of positive control(s): as recommended by the guideline
- Route of administration: oral gavage
- Doses / concentrations: 64 mg/kg bw in 10 mL/kg bw arachis oil
Examinations
- Tissues and cell types examined:
- Bone marrow smears from femur.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
A preliminary test was performed to determine the highest dosage of the test item to be applied in the mutagenicity assay. In this experiment the dose of 5000 mg/kg was determined as the highest applicable in the mutagenicity assay.
TREATMENT AND SAMPLING TIMES
The preparation was administered orally to groups of 24 female and 24 male animals each in the negative and in the 5000 mg/kg bw dose group. The positive control group consisted of 8 female and 8 male animals. Treatment consisted of a single application. 16, 24 and 48h after application 8 female and 8 male animals per sampling time were sacrificed. Bone marrow was harvested from the shafts of both femurs.
DETAILS OF SLIDE PREPARATION:
Bone marrow was harvested from the shafts of both femurs. In a siliconized pipette filled with approx. 0.5 µl rat serum the bone marrow was drawn up. In order to receive a homogenous suspension the content of pipette was aspirated gently about three times. Small drops of the homogenous bone marrow suspension in rat serum were transferred on the end of a slide, spread out by pulling it behind a polished cover glass and the preparations were air-dried. Three hours later, the slides were stained in undiluted May-Grünwald solution for 2 min then in May-Grünwald solution/water 1/1 for 2 min and then in Giemsa's, 40% for 20 min. After being rinsed in methanol 55% for 5-8 sec and washed off twice in water, they were left immersed in water for approx. 2 min. After rinsing with distilled water and air-drying, the slides were cleared in Xylene and mounted in Eukitt.
METHOD OF ANALYSIS:
The slides of five female and five male animals each of the negative control group and of the dosage group sacrificed at 16, 24 and 48 hours post-treatment were examined. The slides of five female and five male animals of the positive control group were scored at 24 hours post-treatment only. 1000 polychromatic erythrocytes each were scored for the incidence of micronuclei per animal. The ratio of polychromatic to normochromatic erythrocytes was determined for each animal by counting a total of 1000 erythrocytes. - Evaluation criteria:
- Not specified.
- Statistics:
- The significance of difference was assessed by X² -test.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: Three groups of four Chinese hamsters (2 females and 2 males) were treated with three different doses, one receiving the maximum dose of 5000 mg/kg bw, and the other two doses of 1/5 and 1/25 of that amount respectively.
- Solubility: no data
- Mortality: no mortality within the observation period of 24, 48 or 72 hours.
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): In comparison to the corresponding vehicle controls there was no biologically relevant or statistically significant enhancement in the frequency of the detected micronuclei at any preparation interval after administration of the test item and with any dose level used.
- Ratio of PCE/NCE (for Micronucleus assay): After treatment with the test item the number of PCEs was not substantially decreased as compared to the mean value of PCEs of the vehicle control thus indicating that the test item did not exert any cytotoxic effects in the bone marrow.
- Appropriateness of dose levels and route: yes
- Statistical evaluation: No statistically significant differences in the frequency of erythrocytes containing micronuclei between the solvent control and the dose groups were observed.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this experiment, no evidence of mutagenic effects was obtained in Chinese hamsters treated with the test substance.
- Executive summary:
In a micronucleus test performed under GLP-like quality control, the test article in arachis oil was given by gavage to three groups of 8 male and 8 female Chinese hamsters. The animals were treated once with the highest applicable dose of 5000 mg/kg and sacrificed 16, 24 and 48 hours thereafter. From the bone marrow smears were made. The negative control animals received the vehicle alone. The bone marrow smears from animals treated with the test substance showed no statistically significant increase (p>0.05) in the number of micronucleated polychromatic erythrocytes compared to the negative control animals at all three sampling times. The respective "positive control" experiments with cyclophosphamide (64 mg/kg) yielded an average of 2.9% polychromatic erythrocytes with micronuclei. This is significantly different from the controls (0.06%) treated with the vehicle (arachis oil) alone. It is concluded that under the conditions of this experiment, no evidence of mutagenic effects was obtained in Chinese hamsters treated with the limit dose of 5000 mg/kg bw of the test article.
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