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EC number: 204-596-5 | CAS number: 123-05-7
- 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: The study was conducted according to OECD guideline 474 (Mammalian Erythrocyte Micronucleus Test) under GLP conditions. There were only minor deviations. The study is fully sufficient for endpoint evaluation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- 2-ethylhexanal
- EC Number:
- 204-596-5
- EC Name:
- 2-ethylhexanal
- Cas Number:
- 123-05-7
- Molecular formula:
- C8H16O
- IUPAC Name:
- 2-ethylhexanal
- Details on test material:
- - Name of test material (as cited in study report): 2-ethylhexanal
- Physical state: colourless to yellow liquid
- Analytical purity: 99.5%
- Impurities (identity and concentrations): not reported
- Purity test date: not reported
- Lot/batch No.: 00STD77L0
- Stability under test conditions: in corn oil, stability analytically verfied with a comparable batch (9147-105)
- Storage condition of test material: at RT (light protected, under nitrogen)
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd., Animal breeding services, CH-4414 Füllinsdorf
- Age at study initiation: 8-10 weeks
- Weight at study initiation: M 33.4g (SD +-0.7g), F 29.8g (SD +-1.3g)
- Fasting period before study: starvation over night, but water ad libitum
- Housing: Makrolon Type I, with wire mesh top (EHRET GmbH, D-79302 Emmendingen)
- Diet: pellet standard diet ad libitum (Harlan Winkelmann GmbH, D-33178 Borchen)
- Water: tap water ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3°C
- Humidity (%): 30-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 6/6 (6.00a.m. - 6.00p.m.)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Justification for choice of solvent/vehicle: corn oil is relatively non-toxic for the animals
- Concentration of test material in vehicle: 200 mg/ml
- Amount of vehicle (if gavage or dermal): 10 ml/kg bw - Duration of treatment / exposure:
- animals received the test substance orally via gavage
- Frequency of treatment:
- single administration
- Post exposure period:
- 24h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2000 mg/kg bw
Basis:
nominal conc.
Limit test
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- yes, historical
- Positive control(s):
- cyclophosphamide (CPA)
- Justification for choice of positive control(s):
- Route of administration: orally, once
- Doses / concentrations: 40mg/kg bw (Volume 10 ml/kg bw)
Examinations
- Tissues and cell types examined:
- - bone marrow
- animals were examined 1h, 2-4h, 6h and 24h after treatment - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: maximum dose - limit test (2000 mg/kg bw)
TREATMENT AND SAMPLING TIMES (in addition to information in specific fields): orally once vie gavage, sampling after 24h
DETAILS OF SLIDE PREPARATION:
- bone marrow was flushed out with fetal calf serum after femora were removed and epiphysis were cut off
- cell suspension was then centrifuged at 390 x g for 10 min, supernatant was discarded
- a small drop of the suspension was spread on a slide and the smear was air dried
- staining with MAY-GRÜNWALD (Merck, D-64293 Darmstadt) / GIEMSA (Gurr, BDH Limited Poole, Great Britain)
- cover slips were mounted with EUKITT (Kindler, D-79110 Freiburg)
METHOD OF ANALYSIS:
- evaluation was performed with an NIKON microscope with 100 x oil immersion objectives
- analysis was performed in coded slides - Evaluation criteria:
- - cytotoxic effect description: ratio of polychromatic erythrocytes (PCE) and total erythrocytes
- 5M and 5F were analyzed
- at least 2000 polychromatic erythrocytes (PCE) were analyzed for micronuclei - Statistics:
- non-parametric Mann-Whitney Test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Mortality: 1M and 1F died after treatment
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
Any other information on results incl. tables
Table shows a summary of the micronucleus test:
Test group |
Dose [mg/kg bw] |
Sampling time (h) |
PCEs with micronuclei (%) |
Range |
PCE per 2000 erythrocytes |
Vehicle |
0 |
24 |
0.035 |
0-2 |
985 |
Test substance |
2000 |
24 |
0.100 |
1-4 |
1012 |
Positive control |
40 |
24 |
1.935 |
14-61 |
936 |
PCE - Polychromatic erythrocytes
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
- Executive summary:
The study was conducted according to OECD guideline 474 (Mammalian Erythrocyte Micronucleus Test) under GLP conditions. There were only minor deviations, the study is fully sufficient for endpoint evaluation. 2-ethylhexanal was tested for micronucleus induction in mouse after single administration of 2000 mg/kg bw (Limit test). A vehicle control and a positive control (cyclophosophamid) CPA for micronucleus formation were run in parallel and were both valid. Twelve animals (6M/6F) were treated per test group and analyzed after 24h (5M/5F). A cytotoxic effect was described as the ratio between polychromatic and total erythrocytes. 1M and 1F died after treatment with this dose. In a prior study (supporting study in this endpoint section) a weak positiv effect was detected, but only males were tested and effect were slightly higher than historical controls. Therefore the study was repeated (this study) in both sexes at the limit dose.
No statistically significant enhancement in the frequency of micronuclei after 2-ethylhexanal exposure was observed in this study. The test substance does not induce micronuclei in mouse erythrocytes in vivo.
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