Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 410-610-2 | CAS number: 111850-24-9 MORTRACE SB CONC.
- 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
- Study period:
- 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD TG 474, EEC Directive 84/449, L 251, B.12 and in accordance with the Principles of Good Laboratory Practices (GLP)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Enviromuental Protection Agency, Code of Federal Regulations, Title 40, Subpart F—Genetic Toxicity, Revision July 1, 1986 “In vivo mammalian bone marrow cytogenetics tests: Micronucleus assay.”
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- MORTRACE SB CONC.
- IUPAC Name:
- MORTRACE SB CONC.
- Reference substance name:
- 4-(4-Nitrophenylazo)-2,6-di- sec.butylphenol
- IUPAC Name:
- 4-(4-Nitrophenylazo)-2,6-di- sec.butylphenol
- Reference substance name:
- 4-(4-nitrophenylazo)-2,6-di-sec-butyl-phenol
- EC Number:
- 410-610-2
- EC Name:
- 4-(4-nitrophenylazo)-2,6-di-sec-butyl-phenol
- Cas Number:
- 111850-24-9
- Molecular formula:
- C20 H25 N3 O3
- IUPAC Name:
- 2,6-bis(butan-2-yl)-4-[2-(4-nitrophenyl)diazen-1-yl]phenol
- Test material form:
- other: dark red-brown liquid
- Details on test material:
- - Name of test material (as cited in study report): Mortrace SB Conc.
- Physical state: dark red-brown liquid
- Analytical purity: concentrate
- Lot/batch No.: MR 26592 SBC
- Expiry date: June 03, 1993
- Stability under storage conditions: stable
- Storage condition of test material: at room temperature protected from light
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sandhofer Weg 7, D-8741 Sulzfeld 1
- Age at study initiation: minimum 10 weeks
- Weight at study initiation: approximately 30 grams
- Assigned to test groups randomly: yes
- Fasting period before study: Approximately 18 hours before treatment with the test article the animals received no food but water ad libitum
- Housing: individually housed
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3°C
- Humidity (%): 30 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Justification for choice of solvent/vehicle: recommeded by various regulatory agencies
- Amount of vehicle (if gavage or dermal): 20 ml/kg body weight - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: On the day of the experiment, the test article was formulated in corn oil. The vehicle was chosen to its relative non—toxicity for the animals. All animals received a single standard volume of 20 ml/kg body weight orally.
- Duration of treatment / exposure:
- single
- Frequency of treatment:
- single
- Post exposure period:
- At the beginning of the treatment the animals were weighed and the individual volume to be administered was adjusted to the animal’s body weight. The animals received the test article once. Twelve animals, six males and six females, were treated per dose group. Sampling of the bone marrow was done 24, 48 and 72 hours after treatment.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 mg/kg body weight
Basis:
nominal conc.
- No. of animals per sex per dose:
- Twelve animals, six males and six females, were treated per dose group
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s): recommended by various regulatory agencies
- Route of administration: orally, once
- Doses / concentrations: 30 mg/kg body weight
Examinations
- Tissues and cell types examined:
- not applicable
- Details of tissue and 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 5 ml syringe. The cell suspension was centrifuged at 1500 rpm 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-6100 Darmstadt)/Gieznsa (Gurr, BDH Limited Poole, Great Britain). Cover slips were mounted with EUKITT (KINDLER, D-7800 Freiburg). At least one slide was made from each bone marrow sample.
Evaluation of the slides was performed using NIKON microscopes with 100x oil immersion objectives. 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. - Evaluation criteria:
- A test article, is classified as mutagenic if it induces a statistically significant increase in the number of micronucleated polychromatic erythrocytes at for at least one of the test points.
A test article producing no statistically significant increase in the number of micronucleated polychromatic erythrocytes at any of the test points is considered non-mutagenic in this system. - Statistics:
- Standard statistical methods were employed
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY - In pre-experiments 4 animals (2 males, 2 females) received orally a single dose of 500, 1000, 2000 or 5000 mg/kg b.w., respectively, Mortrace SB Conc. formulated in corn oil and the volume administered was 20 ml/kg b.w.
Clinical signs of toxicity such as reduction of spontaneous activity, eyelid closure, apathy and abdominal position were noted in the 500 and 1000 mg/kg dose group. The above symptoms along with mortality (50%) was noted in the higher doses of 2000 and 5000 mg/kg bw.. On the basis of these results 1000 mg/kg b.w. Mortrace SB Conc. was estimated to be close to the maximum tolerated dose.
RESULTS OF DEFINITIVE STUDY -
In the micronucleus assay 7 out of 36 animals treated with Mortrace SB Conc. died. The mean number of normochromatic erythrocytes was not increased aftertreatment with the test article as compared to the mean values of NCEs of the corresponding negative controls, indicating that Mortrace SB Conc. had no cytotoxic properties.
In comparison to the corresponding negative controls there was no statistically significant enhancement in the frequency of the detected micronuclei at any preparation interval after application of the test article. The mean values of micronuclei observed after treatment with Mortrace SB conc. were in the same range as compared to the negative control groups.
30 mg/kg b.w. cyclophosphamide administered per os was used as positive control which showed a distinct increase of induced micronuleus frequency.
In conclusion, it can be stated that during the study described and under the experimental conditions reported, the test article did not induce micronuclei as determined by the micronucleus test in the bone marrow cells of the mouse.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
In conclusion, it can be stated that during the study described and under the experimental conditions reported, the test article did not induce micronuclei as determined by the micronucleus test in the bone marrow cells of the mouse. - Executive summary:
The test article Mortrace SB Conc. was assessed in the micronucleus assay for its potential to induce micronuclei in polychromatic erythrocytes (PCE) in the bone marrow of the mouse.
The test article was formulated in corn oil. This vehicle was used as negative control. The volume administered orally was 20 ml/kg b.w.. 24 h, 48 h and 72 h after a single application of the test article the bone marrow cells were collected for micronuclei analysis.
Twelve animals per test group were treated and if available (lethalities were observed after treatment with the test article), ten animals (5 males, 5 females) per test group were evaluated for the occurrence of micronuclei. 1000 polychromatic erythrocytes (PCE) per animal were scored for inicronuclei.
Ten animals (5 males, 5 females) per test group were evaluated for the occurrence of micronuclei. 1000 polychromatic erythrocytes (PCE) per animal were scored for micronuclei.
To describe a cytotoxic effect due to the treatment with the test article the ratio between polychromatic and normochromatic erythrocytes (NCE) was determined in the same sample and reported as the number of NCE per 1000 PCE.
The following dose level of the test article was investigated:
24 h, 48 h, and 72 h preparation interval: 1000 mg/kg b.w..
In pre-experiments this dose level was estimated to be close to the maximum tolerated dose. The animals expressed toxic reactions. However, in the micronucleus assay 7 out of 36 animals treated with Mortrace SB Conc. died.
The mean number of normochromatic erythrocytes was not increased after treatment with the test article as compared to the mean values of NCEs of the corresponding negative controls, indicating that Mortrace SB conc. had no cytotoxic properties.
In comparison to the corresponding negative controls there was no statistically significant enhancement in the frequency of the detected micronuclei at any preparation interval after application of the test article. The mean values of micronuclei observed after treatment with Mortrace SB Conc. were in the same range as compared to the negative control groups.
30 mg/kg b.w. cyclophosphamide administered per os was used as positive control which showed a distinct increase of induced micronuleus frequency.
In conclusion, it can be stated that during the study described and under the experimental conditions reported, the test article did not induce micronuclei as determined by the micronucleus test in the bone marrow cells of the mouse.
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.