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EC number: 221-043-3 | CAS number: 2983-37-1
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- 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:
- study report
- Title:
- Unnamed
- Year:
- 1 977
- Report date:
- 1977
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Freund's Complete Adjuvant Guinea Pig Maximization Test (variation of Magnusson & Kligman method with adjuvant)
- GLP compliance:
- no
- Remarks:
- study performed before implementation of GLP
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- test conducted before first publication of OECD 429 (LLNA test)
Test material
- Reference substance name:
- Ethyl 2-ethylhexanoate
- EC Number:
- 221-043-3
- EC Name:
- Ethyl 2-ethylhexanoate
- Cas Number:
- 2983-37-1
- Molecular formula:
- C10H20O2
- IUPAC Name:
- ethyl 2-ethylhexanoate
- Details on test material:
- - Name of test material: 2-Ethyl-ethylcapronat
- Analytical purity: 100%
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation:
- Weight at study initiation: 265 g (mean, test group), 367 (mean, control group)
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal
- Vehicle:
- olive oil
- Concentration / amount:
- 5%
- Adequacy of induction:
- not specified
Challenge
- Route:
- epicutaneous, open
- Vehicle:
- olive oil
- Concentration / amount:
- 1%
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 20 (test group), 10 (control group)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Test groups: 0.1 mL 5% test substance in olive oil 1:1 with FCA
- Control group: -
- Site: intrascapular region
- Frequency of applications: every 2-3 days
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 d after induction
- Exposure period: 27 h (residual substance was removed 3 h after first reading)
- Test groups: test substance
- Control group: test substance
- Site: right flank
- Concentrations: 1% in olive oil
- Evaluation (hr after challenge): 24 + 48 h - Challenge controls:
- no data
- Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- weakly positive; all aminals showed necrosis after FCA injections, later scars
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: weakly positive; all aminals showed necrosis after FCA injections, later scars.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 3
- Total no. in group:
- 20
- Clinical observations:
- 3 animals with clear positive, 15 animals with weakly irritant reactions
- Remarks on result:
- other: Reading: 2nd reading. Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. positive reactions: 3.0. Total no. in groups: 20.0. Clinical observations: 3 animals with clear positive, 15 animals with weakly irritant reactions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this sensitisation study according to a variation of the Magnusson and Kligman procedure test item was regarded as a weak dermal sensitiser.
- Executive summary:
In a dermal sensitisation study with 2-Ethyl ethyl capronate (100% a.i.), female adult Pirbright white guinea pigs (20 in test group, 10 in control group) were tested using a variation of the Magnusson and Kligman procedure.
The substance was prepared by blending a 5% preparation of the test substance in olive oil with Freund's adjuvant at a 1:1 ratio. 10 injections were applied at intervals of 2 -3 days into in intrascapular region. 14 d after induction, the test substance was applied epicutaneously to the right flank. Skin reactions were read twice after challenging at intervals of 24 hours.
After 24 h 2/10 animals showed slightly positive reactions. In 3/20 animals, clearly positive reactions were observed 48 hours after challenging. Further 15 animals showed slight skin reactions.
According to these results 2-Ethyl ethyl capronate is a weak dermal sensitiser.
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