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EC number: 244-815-1 | CAS number: 22174-70-5
- 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
Endpoint summary
Administrative data
Description of key information
2-ethylhexylal was identified as not irritating to skin and eyes in in vivo test performed according to OECD TG 404 and 405 (GLP). An in vitro test shows that 2-ethylhexylal is not corrosive OECD TG 431 and GLP).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2008-04-29 to 2008-05-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP lab following OECD guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 431 (In vitro skin corrosion: Human Skin Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- human
- Strain:
- other: Episkin Standard Model
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 3, 60 and 240 minutes
- Observation period:
- 3 hours after end of exposure
- Irritation / corrosion parameter:
- other: other: Cell Viability
- Value:
- > 35
- Remarks on result:
- other:
- Remarks:
- Basis: mean. Time point: 240 minutes. Reversibility: no data. Remarks: Following OECD Guideline 431: the cell viability is never below 35% even after 4 hours exposure. (migrated information)
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information: non corrosive
- Conclusions:
- According to the obtained results (cell viability never below 35% for tested exposure time) and reporting to the UN and EU classification criterias for corrosive chemical categorisation, we can conclude that the organic solvent 2-ethylhexylal can be classified as non corrosive.
- Executive summary:
The objective of this study is to predict and classify the skin corrositivity potential of the chemical product 2-ethylhexylal according to chemical safety regulation, by assessment of its effect on a reconstructed human epidermis.
The principle of this test is based on the experience that corrosive chemicals show cytotoxic effect following short-term exposure on the stratum corneum of the epidermis. The test protocol does not provide adequate information on skin irritation. The assay was conducted according to the OECD guideline n° 431 "In vitro skin corrosion: Human Skin Model Test".
The Episkin is a highly differentiated and stratified epidermis validated model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum obtained after a culture period. Its use for skin corrositivity testing involves topical application of the test material to the surface of the epidermis, and the subsequent assessment of its effects on cell viability.
The selected positive and negative reference chemicals are phosphate buffer saline and acetic acid glacial.
Corrositivity potential of 2-ethylhexylal involved topical application of test item to the surface of the reconstructed human epidermis and the subsequent assessment of its effect on cell viability. 10µl of the test item was applied topically to the epidermal model for 3, 60 and 240 minutes (3 epidermis units were used per test material, 2 for positive and 1 for negative controls and time exposure). At the end of the treatment, all residual test item and chemical controls were removed by thoroughly rinsing epidermis units with 25 ml of sterile phosphate buffered saline solution. The resulting cell viability was further assessed by incubating tissues for 3 hours at 37°C, 5% CO2 atmosphere with MTT (0.3 mg/ml) in assay medium. The basis of this test is that viable cells metabolize MTT into intra-cellular formazan crystals. The precipitated formazan was finally extracted using acidified isopropanol and quantified spectrophotometrically at 550 nm by comparison to a blank (acidified propanol).
According to the obtained results (cell viability never below 35% for tested exposure time) and reporting to the UN and EU classification criteria for corrosive chemical categorization, we can conclude that the organic solvent 2-ethylhexylal can be classified as non corrosive (OECD 431: non-corrosive to skin if the viability after 3 minutes exposure is greater than or equal to 50% and the viability after 1 hour exposure is greater than or equal to 15%).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: breeding farm VELAZ s.r.o., Kolec u Kladna, Czech Republic, RCH CZ 21760152
- Age at study initiation: 4-5 months
- Weight at study initiation: 2.3-2.4 kg
- Housing: Conventional animal room – individually in metallic cages
- Diet (e.g. ad libitum): Standard pelleted diet TM-MAK 1 for rabbits and guinea pigs ad libidum (producer: Ing. Mrkvicka Miroslav – Vyroba krmnych smesi, Mlyn Kocanda, 252 42 Jesenice u Prahy)
- Water (e.g. ad libitum): Drinking tap water ad libitum (quality corresponding to the Regulation No.: 252/2004 Czech Coll. Of Law)
- Acclimation period: not specified - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): used in delivered form (undiluted) - Duration of treatment / exposure:
- Duration of exposure corresponds to duration of observation
- Observation period (in vivo):
- The eyes were examined at 1, 24, 48 and 72 hours after application, then once daily. After recording the observations at 24 hours, the eyes of rabbit were examined with the aid of fluorescinein and the ophthamoscopy. The grades of ocular reaction for single animal (observation of conjunctivae, cornea and iris) were recorded at each examination.
- Number of animals or in vitro replicates:
- 3 (1 male and 2 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure: Not relevant
SCORING SYSTEM:
CORNEA
0 - No ulceration or opacity
1 - Scattered or diffuse areas of opacity; details of iris clearly visible
2 - Easily discernible translucent area;details of iris slightly obscured
3 – Nacrous area, no details of iris visible, size of pupil barely discernible
4 – Opaque cornea, iris not discernible through the opacy
Maximum possible: 4
IRIS
0 - Normal
1 – Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperemia ; or injection ; iris reactive to light (a sluggish reaction is considered to be an effect)
2 – Hemorrhage, gross destruction, or no reaction to light
Maximum possible: 2
CONJUNCTIVAE
0 - Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris) normal
1 - Some blood vessels hyperarmic (injected)
2 - Diffuse, crimson color, individual vessels not easily discernible
3 - Diffuse beefy red
Maximum possible: 3
CHEMOSIS
0 - Normal no alterations
1 - Some swelling above normal
2 - Obvious swelling with partial eversion of lids
3- Swelling with lids about half closed
4 - Swelling with lids more than half closed
Maximum possible: 4
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein - Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, 2 and 3
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- Please refer to “Overall irritation/corrosion results”
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Examination of eye irritation after single application demonstrated, that the test substance, 2-ethylhexylal, is not irritating for eye of rabbit.
- Executive summary:
The test substance,2-ethylhexylal, was tested for the assessment of eye irritation/corrosion effects using albino rabbit (New Zealand Albino breed).
The test was performed according to the Method B.5 Acute Toxicity: Eye Irritation/Corrosion. Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.
The test was performed initially using one animal (No. 7). If the results of this test indicate the substance to be corrosive or a severe irritant to the eye, the response was confirmed using two additional animals (No. 8 and No. 9).
The following changes were observed on eye at 1 hour after application: conjunctivae - diffuse, crimson color, individual vessels not easily discernible; chemosis – some swelling above normal in all rabbits. Conjunctivae – diffuse, crimson color, individual vessels not easily discernible or some blood vessels hyperaemic (injected) were observed in all rabbits at the 24 hours after application. Conjunctivae – some blood vessels hyperaemic (injected) were observed in two rabbits (No. 8 and No. 9) at the 48 hours after application. No changes on the conjunctival sac were observed at the 72 hours after application in all animals.
No clinical signs of systemic intoxication were detected.
Examination of eye irritation after single application demonstrated, thatthe test substance, 2-ethylhexylal, is not irritating for eye of rabbit.
Reference
Body weights were recorded in the table below:
Rabbit No. |
Clinical observation |
Body weight (in kg) |
|
prior to application |
at termination |
||
1 |
No changes |
2.40 |
2.60 |
2 |
No changes |
2.40 |
2.70 |
3 |
No changes |
2.30 |
2.50 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
2-ethylhexylal is not classified for its irritating effects to skin and eyes according to the CLP principles.
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.
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