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EC number: 425-400-6 | CAS number: 179986-09-5
- 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
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD, GLP, QAU)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Version / remarks:
- adopted May 26, 1983
- Deviations:
- yes
- Remarks:
- only 1000 polychromatic erythrocytes/animal were counted, the guideline was updated in 1997, here the analysis of 2000 polychromatic erythrocytes/animal is designated
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- -
- EC Number:
- 425-400-6
- EC Name:
- -
- Cas Number:
- 179986-09-5
- Molecular formula:
- UVCB substance
- IUPAC Name:
- methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate; propane-1,2,3-triol; tetradecanoic acid
- Details on test material:
- - Physical state: liquid, colourless
- Analytical purity: 95%
- Storage condition of test material: room temperature
No further information.
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, CH-4414 Füllinsdorf
- Age at study initiation: 8-12 weeks
- Weight at study initiation: males/females mean value: 31.9/25.7 g
- Assigned to test groups randomly: yes
- Fasting period before study: approximately 18 hours before treatment the animals received no food but water ad libitum.
- Housing: single in Makrolon type I, with wire mesh top
- Diet (ad libitum): pelleted standard diet (Altromin 1324)
- Water (ad libitum): tap water
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: polyethylene glycol 400
- Amount of vehicle (if gavage or dermal): 10 ml/kg bw - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: prior to administration
- Frequency of treatment:
- once
- Post exposure period:
- 24 and 48 hours
Doses / concentrations
- Remarks:
- Doses / Concentrations:
200, 670, 2000 mg/kg bw
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Route of administration: oral
- Doses / concentrations: 40 mg/kg bw
Examinations
- Tissues and cell types examined:
- polychromatic erythrocytes
- Details of tissue and slide preparation:
- TREATMENT AND SAMPLING TIMES (in addition to information in specific fields): Animals were treated once orally. Sampling of the bone marrow was done 24 and 48 hours after treatment, respectively.
DETAILS OF SLIDE PREPARATION: The animals were sacrificed by cervical dislocation. The femora were removed, the epiphyses were cut off and the marrow was flushed out with fetal calf serum, using a syringe. The cell suspension was centrifuged at 1500 rpm (390 x g) for 10 minutes and the supernatant was discarded. A small drop of the resuspended cell pellet was spread on a slide. The smear was air-dried and then stained with May-Grünwald (MERCK, D-64293 Darmstadt)/Giemsa (Gurr, BDH Limited Poole, Great Britain). Cover slips were mounted with EUKITT (KENDLER, D-79110 Freiburg). At least one slide was made from each bone marrow sample.
METHOD OF ANALYSIS: Evaluation of the slides was performed using NIKON microscopes with 100x oil immersion objectives. At least 1000 polychromatic erythrocytes (PCE) were analysed per animal for micronuclei. To describe a cytotoxic effect the ratio between polychromatic and normochromatic erythrocytes was determined in the same sample and expressed in normochromatic erythrocytes per 1000 the PCEs. The analysis was performed with coded slides. Five animals per sex and group were evaluated as described. The remaining 6th animal of each test group was evaluated in case an animal had died in its test group. - Evaluation criteria:
- The test substance is classified as mutagenic if it induces either a dose-related increase in the number of micronucleated polychromatic erythrocytes or a statistically significant positive response for at least one of the test points.
The test substance producing neither a dose-related increase in the number of micronucleated polychromatic erythrocytes nor a statistically significant positive response at any of the test points is considered non-mutagenic in this system. - Statistics:
- Mann-Whitney test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose: 2000 mg/kg bw
- Solubility: the test substance was formulated in PEG 400
- Clinical signs of toxicity in test animals: reduction of spontaneous activity, apathy
Any other information on results incl. tables
Table 1: Micronuclei in polychromatic erythrocytes in male and female mice (5 animals/sex) scoring 24 and 48 hours after treatment
Sex (m/f) |
Hours after treatment |
Dose (mg/kg bw) |
Micronucleated cells per 1000 PCEs per animal |
M |
24 |
Vehicle |
4 |
F |
24 |
Vehicle |
3 |
M |
24 |
200 |
6 |
F |
24 |
200 |
4 |
M |
24 |
670 |
3 |
F |
24 |
670 |
3 |
M |
24 |
2000 |
6 |
F |
24 |
2000 |
3 |
M |
24 |
Positive control |
97 |
F |
24 |
Positive control |
62 |
M |
48 |
2000 |
3 |
F |
48 |
2000 |
4 |
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.