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EC number: 907-349-6 | CAS number: -
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable, well documented study report which meets basic scientific principles
Data source
Reference
- Reference Type:
- other: microfiche
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- yes
- Remarks:
- - only 1000 immature erythrocytes per animal were scored for the incidence of micronucleated erythrocytes
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Octadecyl isocyanate
- EC Number:
- 204-019-7
- EC Name:
- Octadecyl isocyanate
- Cas Number:
- 112-96-9
- Molecular formula:
- C19H37NO
- IUPAC Name:
- 1-isocyanatooctadecane
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- ICR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague Dawley, Inc. (Frederick, MD)
- Age at study initiation: 6 - 8 weeks
- Weight at study initiation: males: 27-36 g; females: 18-26 g
- Housing: five per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 3
- Humidity (%): 50 +/- 20
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: none
- Duration of treatment / exposure:
- single i.p. injection
- Frequency of treatment:
- once
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 0.5, 2.5, 5.0 ml/kg
Basis:
other: actual injected dose
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- triethylenemelamine (TEM) dissolved in distilled water, single i.p. injection with 0.25 mg/kg bw
Examinations
- Tissues and cell types examined:
- Using oil immersion, 1000 polychromatic erythrocytes (PCEs) per animal were scored for the presence of micronuclei. The proportion of polychromatic erythrocytes to total erythrocytes and the number of micronucleated normocytes in the field of 1000 polychromatic erythrocytes were also enumerated.
- Details of tissue and slide preparation:
- At the scheduled sacrifice times, five mice per sex per treatment were sacrificed by CO2 asphyxiation. Immediately following sacrifice, the femurs were exposed, cut just above the knee, and the bone marrow was aspirated into a syringe containing fetal bovine serum. The bone marrow cells were transferred to a capped centrifuge tube containing approximately 1 mL fetal bovine serum. The bone marrow cells were pelleted by centrifugation at approximately 100 x g for five minutes and the supernatant was drawn off, leaving a small amount of serum with the remaining cell pellet. The cells were resuspended by aspiration with a capillary pipet and a small drop of bone marrow suspension was spread onto a clean glass slide. Two to four slides were prepared from each mouse. The slides were fixed in methanol, stained with May-Gruenwald-Giemsa and permanently mounted. Slides were coded using a random number table by an individual not involved with the scoring process. Using medium magnification, an area of acceptable quality was selected such that the cells were weIl spread and stained.
- Evaluation criteria:
- The mean incidence of micronucleated polychromatic erythrocytes must not exceed 5/1000 polychromatic erythrocytes (0.5 %) in the negative control. The incidence of micronucleated polychromatic erythrocytes in the positive control group must be significantly increased relative to the negative control group (p<=0.05, Kastenbaum-Bowman Tables).
- Statistics:
- Statistical significance will be determined using the Kastenbaum-Bowman tables which are based on the binomial distribution.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- GENERAL TOXICITY:
One male receiving 5 ml/kg and one female receiving 2.5 ml/kg died immediately followinq the i.p. injection; death was assumed to be a dosing accident and these mice were replaced. All animals appeared normal several minutes after dose administration and during the course of the study.
RATIO OF POLYCHROMATIC ERYTHROCYTES TO TOTAL ERYTHROCYTES:
The incidence of micronucleated polychromatic erythrocytes per 1000 polychromatic erythrocytes scored and the proportion of polychromatic erythrocytes per total erythrocytes are summarized and presented for each treatment group by sacrifice time in Table 1. No reduction in the ratio of
polychromatic erythrocytes to total erythrocytes in males or females suggests no bone marrow toxicity.
MICRONUCLEATED POLYCHROMATIC ERYTHROZYTES:
The number of micronucleated polychromatic erythrocytes per 1000 polychromatic erythrocytes was not statistically increased in males and females, regardless of dose level or bone marrow collection times (p>0.05, Kastenbaum-Bowman Tables). TEM induced a significant increase in micronucleated polychromatic erythrocytes in male and female mice relative to the negative
control (p<=0.05, Kastenbaum-Bowman Tables).
Any other information on results incl. tables
Table 1: Summary of results from the bone marrow micronucleus test with octadecyl isocyanate
Treatment | Sex |
Time (hr) |
Number of mice |
PCE/total erythrocytes (Mean) |
Micronucleated poly- chromatic number per 1000 PCEs (Mean ± S.D.) |
Erythrocytes number per PCEs scored |
Water | ||||||
5 ml/kg | M | 24 | 5 | 0.55 | 0.6 ± 0.55 | 3 / 5000 |
48 | 5 | 0.57 | 0.4 ± 0.55 | 2 / 5000 | ||
72 |
5 | 0.56 | 0.8 ± 0.84 | 4 / 5000 | ||
F | 24 | 5 | 0.56 | 1.2 ± 0.84 | 6 / 5000 | |
48 | 5 | 0.54 | 2.2 ± 1.79 | 11 / 5000 | ||
72 |
5 | 0.57 | 0.8 ± 0.84 | 4 / 5000 | ||
Octadecyl isocyanate |
||||||
0.5 ml/kg |
M | 24 | 5 | 0.49 | 0.6 ± 0.89 | 3 / 5000 |
48 | 5 | 0.60 | 0.8 ± 0.84 | 4 / 5000 | ||
72 | 5 | 0.55 | 1.0 ± 0.71 | 5 / 5000 | ||
F | 24 | 5 | 0.57 | 1.4 ± 1.14 | 7 / 5000 | |
48 | 5 | 0.63 | 1.0 ± 0.71 | 5 / 5000 | ||
72 | 5 | 0.55 | 0.6 ± 0.89 | 3 / 5000 | ||
2.5 ml/kg |
M | 24 | 5 | 0.50 | 0.8 ± 1.30 | 4 / 5000 |
48 | 5 | 0.58 | 0.8 ± 0.45 | 4 / 5000 | ||
72 | 5 | 0.51 | 0.4 ± 0.55 | 2 / 5000 | ||
F | 24 | 5 | 0.48 | 0.6 ± 0.89 | 3 / 5000 | |
48 | 5 | 0.61 | 1.2 ± 1.10 | 6 / 5000 | ||
72 | 5 | 0.52 | 0.2 ± 0.45 | 1 / 5000 | ||
5.0 ml/kg |
M | 24 | 5 | 0.59 | 0.6 ± 0.89 | 3 / 5000 |
48 | 5 | 0.58 | 0.2 ± 0.45 | 1 / 5000 | ||
|
72 | 5 | 0.54 | 0.2 ± 0.45 | 1 / 5000 | |
F | 24 | 5 | 0.55 | 0.4 ± 0.55 | 1 / 5000 | |
48 | 5 | 0.58 | 0.0 ± 0.00 | 0 / 5000 | ||
72 | 5 | 0.55 | 0.0 ± 0.00 | 0 / 5000 | ||
TEM |
||||||
0.25 mg/kg |
M | 24 | 5 | 0.47 | 48.4 ± 21.01 | 242 / 5000 * |
F | 24 | 5 | 0.49 | 39.0 ± 4.64 | 195 / 5000 * |
* p ≤ 0.05 (Kastenbaum-Bowman Tables)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
- Executive summary:
Male and female ICR mice were exposed to 0.5, 2.5 or 5 ml/kg of octadecyl isocyanate which was administered as a single i.p. injection. Bone marrow cells, collected 24, 48 and 72 hours after treatment, were examined microscopically for micronucleated polychromatic erythrocytes. No change in the ratio of polychromatic erythrocytes to total erythrocytes was observed in male or female mice in the test article treated groups,suggesting that the test article did not induce bone marrow toxicity. No significant increases in micronucleated polychromatic erythrocytes were observed at 24, 48 or 72 hours after dose administration in males or females. The results of the assay indicate that under the conditions described, octadecyl isocyanate did not induce a significant increase in micronucleated polychromatic erythrocytes in male or female ICR mice. Therefore, octadecyl isocyanate was concluded to be negative in the mouse micronucleus assay.
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