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EC number: 941-814-4 | CAS number: 157367-45-8
- 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:
- 14 April 1993 to 6 July 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to EU Method B.12 under 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:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- only male animals were used
- Principles of method if other than guideline:
- Not relevant
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 308 AQN
- IUPAC Name:
- 308 AQN
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Sufficient male albino CD1 strain mice were supplied by Charles River (UK) Ltd., Manston, Kent. At the start of the main study the mice weighed 24 - 31g and were approximately five to seven weeks old. After a minimum acclimatisation period of five days the animals were selected at random and given a unique number within the study by ear punching and a number written on a colour cage card.
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Suspension in arachis oil B.P.
- Details on exposure:
- Dose Level:
2000 mg/kg oral
2000, 1000, 500, 250, 125, 60, 30, 20, 10, 5 mg/kg i.P. - Duration of treatment / exposure:
- all animals were dosed once
- Frequency of treatment:
- once
- Post exposure period:
- observation period 2 days
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
20 mg/kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
10 mg/kg
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
5 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- Groups of seven male mice per dose were used.
In addition three further groups of male mice were included in the study; two groups of seven mice were dosed wia the intraperitoneal route with the vehicle alone (arachis oil B.P.) and the third group (five mice) was dosed orally with cyclophosphamide, a positive control material. - Control animals:
- yes
- Positive control(s):
- One group (five mice) was dosed orally with cyclophosphamide, a positive control material.
Examinations
- Tissues and cell types examined:
- Both femurs of each test animals were examined.
- Details of tissue and slide preparation:
- Immediately following sacrifice, both femurs were dissected from each animal, aspirated with foetal calf serum and bone marrow smears prepared following centrifugation and re-suspension. The smears were air-dried, fixed in absolute methanol, and stained in May-Grünwald/Giemsa.
- Evaluation criteria:
- Stained bone marrow smears were coded and eamined blind using light microscopy at x 1000 magnification. the incidence of micronucleated cells per 2000 polychromatic erythrocytes (PCE-blue stained immature cells) per animal was scored, in this study the incidence of micronucleated cells per 4000 polychromatic erythrocytes was scored for the 24 hour 20 mg/kg group due to only four animals being available for evaluation and consequently statistical analysis. Micronuclei are normally circular in shape, although occassionally 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 total erythrocytes were counted; these cells were also scored for incidence of micronuclei.
When a micronucleus slide is scored the slide assessor scores NCE and PCE until a total of 1000 erythrocytes (NCE + PCE) have been scored. At this point the number of NCE's is recorded and no more NCE's are scored. The slide scorer then continues scoring PCE's until a total of 2000 PCE's have been scored. Therefore the PCE/NCE ratio is obtained during the first half of 2000 scored PCE.
PCE number scored is usually 2000 unless, due to sample loss or insufficient bone marrow obtained, fewer PCE's are scored. PCE + MN relates to the number of PCE's with micronuclei seen within the number of PCE's scored. NCE number scored relates to the number of NCE scored within 1000 total erythrocytes (PCE + NCE), and NCE + MN relates to the number of NCE seen within this number with micronuclei. PCE/NCE ratio is obtained from the equation (1000 -NCE scored)/NCE scored. - Statistics:
- The individual ratio of polychromatic to normochromatic erythrocytes was calculated together with appropriate group mean values and standard deviations.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- There were premature deaths in animals dosed via theintraperitoneal route with 308 AQN at and above 20 mg/kg.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
308 AQN was considered to be non-genotoxic under the conditions of the test. - Executive summary:
There was no evidence of toxicologically significant increases in the incidence of micronucleated polychromatic erythrocytes in animals dosed with 308 AQN when compared to the concurrent vehicle control groups. No significant change in the PCE/NCE ratio was observed after dosing with 308 AQN.
The positive control material produced a large and significant increase in the frequency of micronucleated polychromatic erythrocytes.
The test material, 308 AQN, was considered to be non-genotoxic under the conditions of the test.
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