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EC number: 412-300-2 | CAS number: 139504-68-0 AMBER CORE
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- from 16 October 2008 to 11 December 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study but there was no data on the test substance (purity)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
- Reference Type:
- other: Statement of purity for Amber core
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- : no certificate of analysis, few data on the test substance.
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 2007-10-15, Department of health of the government of the United kingdom
- Type of assay:
- micronucleus assay
Test material
- Details on test material:
- - Name of test material (as cited in study report): Amber Core (P#620), 1-(2-tert-Butylcyclohexyloxy)-2-butanol
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: albino Hsd:ICR (CD-1)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK
- Age at study initiation: 5-8 weeks old
- Weight at study initiation: 22 to 30g
- Assigned to test groups randomly: yes
- Fasting period before study: no data
- Housing: in groups of up to 7 in solid-floor polypropylene cages with wood-flake bedding.
- Diet (e.g. ad libitum): free access to Harlan Teklad 2014 Rodent Pelleted Diet
- Water (e.g. ad libitum): free access
- Acclimation period: Yes, for 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: no data
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: Sodium chloride 0.9% w/v
- Justification for choice of solvent/vehicle: no data
- Concentration of test material in vehicle: 100 or 200 mg/mL
- Amount of vehicle (if gavage or dermal): 10 mL/kg bw
- Type and concentration of dispersant aid (if powder): not applicable
- Lot/batch no. (if required): 300407503
- Purity: no data - Details on exposure:
- See details in Table 7.6.2/2.
- Duration of treatment / exposure:
- the test subtance was injected, and 24 or 48 after this administration, the animals were killed.
- Frequency of treatment:
- once only.
- Post exposure period:
- One group of mice from each dose level was killed 24 hours following treatment and a second group dosed with test material at 2000 mg/kg bw was killet at 48 hours.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500; 100; 2000 mg/kg bw
Basis:
nominal conc.
- No. of animals per sex per dose:
- Main test: 7 male mice/dose group
- Positive control(s):
- cyclophosphamide (Acros Organics, batch no. A0164185)
- Justification for choice of positive control(s): Cyclophosphamide is known to produce micronuclei under the conditions of the test.
- Route of administration: oral route
- Doses / concentrations: the positive control material was freshly prepared as required as a solution at the appropriate concentration in distilled water.
Examinations
- Tissues and cell types examined:
- All animals were observed for signs of overt toxicity and death one hour after dosing and then once daily as applicable and immediately prior to termination.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: the doses were selected in accordance with the results obtained in the range-finding study.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): no additionnal information
DETAILS OF SLIDE PREPARATION: Immediately after termination, both femurs were dissected from each animal, aspirated with foetal calf serum and bone marrow smears prepared following centrifugation and re-suspension. These smears were air-dry and cover-slipped using mounting medium.
METHOD OF ANALYSIS: Stained bone marrow smears were coded and examined blind using light microscopy at x1000 magnification.
OTHER: The incidence of micronucleated cells per 2000 polychromatic erythrocytes (PCE-blue stained immature cells) per animal was scored. Micronuclei are normally circular in shape, although occasionally they may be oval or half-moon shaped, and have a sharp contour with even staining. In addition, the number of normochromatic erythrocytes (NCE-pink stained mature cells) associated with 1000 erythrocytes was counted; these cells were also scored for incidence of micronuclei. The ratio of polychromatic to normochromatic erythrocytes was calculated together with appropriate group mean values and standard deviations. - Evaluation criteria:
- A comparison was made between the number of micronucleated PCE occuring in each of the test material groups and the number occuring in the corresponding vehicle control group. A positive mutagenic response was demonstrated when a statistically significant, dose-responsive, toxicologically relevant increase in the nhumber of micronucleated PCE was observed for either the 24 or 48-hour kill times when compared to their corresponding group.
A positive response for bone marrow toxicity was demonstrated when the dose group mean polychromatic to normochromatic ratio was shown to be statistically significantly lower than the concurrent vehicle control group. - Statistics:
- Student's t test following a ѵ(x+1) transformation, ANOVA 1
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 1000-2000 mg/kg bw
- Solubility: no data
- Clinical signs of toxicity in test animals: no death occured at any dose level and at any exposure mode (oral or intraperitoneal). In animals dosed with the test material via the intraperitoneal route, clinical signs were observed at 2000 mg/kg bw (Huched posture and ptosis).
- Evidence of cytotoxicity in tissue analyzed: not examined
- Rationale for exposure: The test material showed no marked difference in its toxicity to male or female mice; it was therefore considered to be acceptable to use males only for the main test. No evidence of toxicity was observed in animals dosed with test material via the oral route and, therefore systemic absorption could not be confirmed using this dose route. Adequate evidence of test material toxicity was demonstrated via the intraperitoneal route of administration, therefore this was selected for use in the main test. The maximum recommended dose of the test material, 2000 mg/kg bw, was selected for use in the main test, with 1000 and 500 mg/kg bw as the lower dose levels.
- Harvest times: not applicable
- High dose with and without activation: not applicable
RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): not applicable
- Induction of micronuclei (for Micronucleus assay): there was no statistically significant increase in the incidence of micronucleated PCE (see details in table 7.6.2/3).
- Ratio of PCE/NCE (for Micronucleus assay): modest decrease (but not statistically significant) in the PCE/NCE ratio in both the 24 and 48h test material dose groups when compared to their concurrent control groups. This, together with the observation of clinical signs (Hunched posture, ataxia, lethargy, ptosis and splayed gait) was taken to indicate that systemic absorption had occurred and exposure to the target tissue had been achieved (see details in table 7.6.2/3).
- Appropriateness of dose levels and route: see above.
- Statistical evaluation: the number of micronucleated PCE was statistically increased only for the positive control (P<0.001)
Any other information on results incl. tables
Table 7.6.2/3:Results obtained in the main test
Treatment group |
Dose level (mg/kg bw) |
Kill time (hours after dosing) |
Number of PCE with micronuclei per 2000 PCE |
PCE/NCE ratio |
||
Group Mean |
SD |
Group Mean |
SD |
|||
Vehicle control |
0 |
24 |
1.3 |
1.5 |
0.65 |
0.11 |
Amber Core (P#620) |
500 |
0.1 |
0.4 |
0.51 |
0.5 |
|
1000 |
0.9 |
1.6 |
0.65 |
0.18 |
||
2000 |
0.3 |
0.5 |
0.57 |
0.18 |
||
Positive control |
50 |
23.0*** |
5.4 |
0.72 |
0.17 |
|
Vehicle control |
0 |
48 |
0.9 |
1.2 |
0.80 |
0.30 |
Amber Core (P#620) |
2000 |
0.6 |
1.1 |
0.53 |
0.17 |
PCE: Polychromatic erythrocytes
NCE: Normochromatic erythrocytes
SD: Standard deviation
*** : P<0.001
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Under the test conditions, Amber Core (P#620) is not considered as genotoxic in this micronucleus test. - Executive summary:
In an in vivo micronucleus assay performed according to the OECD guideline No. 474, and in compliance with the GLP, Amber core (P#620) (purity unknown) was administratedviaintraperitoneal route to male albino Hsd:ICR (CD-1) mice (7 animals/dose level). In a preliminary test, two mice (one female, one male) were dosed once only at the appropriate dose level by gavage using a metal cannula or with a hypodermic needle attached to a graduated syringe. In the preliminary test, the test material showed no marked difference in its toxicity to male or female mice; it was therefore considered to be acceptable to use males only for the main test. No evidence of toxicity was observed in animals dosed with test materialviathe oral route and, therefore systemic absorption could not be confirmed using this dose route. Adequate evidence of test material toxicity was demonstratedviathe intraperitoneal route of administration, therefore this was selected for use in the main test. The maximum recommended dose of the test material, 2000 mg/kg bw, was selected for use in the main test, with 1000 and 500 mg/kg bw as the lower dose levels.
In the main, test, animals were therefore treated with Amber Core via one intraperitoneal injection. 24 or 48 Hours after the treatment, animals were killed and bone marrow was collected for further analysis. The incidence of micronucleated cells per 2000 polychromatic erythrocytes (PCE-blue stained immature cells) per animal was scored. In addition, the number of normochromatic erythrocytes (NCE-pink stained mature cells) associated with 1000 erythrocytes was counted; these cells were also scored for incidence of micronuclei. The ratio of polychromatic to normochromatic erythrocytes was calculated in order to determine the toxicity of the test material.
A modest decrease (but not statistically significant) was observed in the PCE/NCE ratio in both the 24 and 48h test material dose groups when compared to their concurrent control groups. This, together with the observation of clinical signs (Hunched posture, ataxia, lethargy, ptosis and splayed gait) was taken to indicate that systemic absorption had occurred and exposure to the target tissue had been achieved. Furthermore, there was no statistically significant increase in the incidence of micronucleated PCE.
In conclusion, under the test conditions, Amber Core (P#620) is not considered as genotoxic in thisin vivomicronucleus test. Therefore, Amber Core is not classified as genotoxic according to the criteria of the Annex VI of the of the Regulation (EC) No 1272/2008 (CLP) and the Annex VI of the Directive 67/548/EC.
This study is considered as acceptable as it satisfied the criteria of the OECD Guideline No. 474.
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.
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