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EC number: 203-233-8 | CAS number: 104-75-6
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- according to: Gad, S.C. et al. Toxicol. Appl. Pharmacol., 84, 93-114, 1986
- GLP compliance:
- yes
- Type of study:
- mouse ear swelling test
- Justification for non-LLNA method:
- The Mouse Ear Swelling Test (1987) met the previous requirements before the entry into force of REACH. This test is suitable and reliable to cover this endpoint. For this reason and for animal welfare reasons, no further in vivo study (LLNA test) needs to be performed.
Test material
- Reference substance name:
- 2-ethylhexylamine
- EC Number:
- 203-233-8
- EC Name:
- 2-ethylhexylamine
- Cas Number:
- 104-75-6
- Molecular formula:
- C8H19N
- IUPAC Name:
- 2-ethylhexylamine
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- not specified
- Details on test animals and environmental conditions:
- - Age:6-8 weeks
- Weight at study initiation: 20-24 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: 70% ethanol
- Concentration / amount:
- 5%
- Day(s)/duration:
- Day 0, 1, 2, and 3, respectively
- Adequacy of induction:
- other: a non-corrosive concentration
- Route:
- intradermal
- Concentration / amount:
- application of Freund's Complete Adjuvans (FCA)
- Day(s)/duration:
- Day 0
Challengeopen allclose all
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- other: 70% ethanol
- Concentration / amount:
- 25%
- Day(s)/duration:
- Day 10
- No.:
- #2
- Route:
- epicutaneous, open
- Vehicle:
- other: 70% ethanol
- Concentration / amount:
- 25%
- Day(s)/duration:
- Day 17
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
Doses were chosen in a range-finding study.
-Positive control: induction: 0.5% w/v mixture DCNB in 70% ethanol
challenge: 1.0% w/v mixture DCNB in 70% ethanol
-Test substance: induction: 5.0% w/v mixture 2-ethylhexylamine in 70% ethanol (non-corrosive)
challenge: 25% w/v mixture 2-ethylhexylamine in 70% ethanol non-corrosive)
-Adjuvant: 50% v/v Freund's Complete Adjuvant (FCA)in water
EXPOSURE:
On day 0 of induction, 20 µL FCA was administered by i.d. injection on and left and right sides of the abdomen of all animals. On days 0, 1, 2, and 3 of induction, the test (100 µL) or control substance was administered topically to the abdomen and an appropriate vehicle was applied to the irritation control animals. The test (10 µL) and positive control animals were challenged on day 10 on the left ear (dorsal and ventral surfaces) and re-challenged on day 17 on the right ear. An appropriate vehicle was applied to the opposing ear. Five irritation control animals (previously treated with vehicle and FCA) were subjected to the same challenge as the test animals on day 10 and another set of five on Day 17.
EXAMINATIONS:
- Mortality and clinical signs: twice daily
- Presence of irritation (erythema,edema): day 9 and 16
- Evaluation of dermal response (ear thickness under light anesthesia with ether): 24 and 48 hr after challenge or re-challenge
- The sensitization response was considered positive if the test ear was 20% thicker than the control ear.
STATISTICAL METHOD:
- Not applicable
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitrochlorobenzene (DCNB)
Results and discussion
- Positive control results:
- 80 and 100% of the animals showed a positive response (at least 20% increase in ear thickness) after 24 and 48 h, respectively.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 1%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- rechallenge
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
Any other information on results incl. tables
TEST GROUP:
Few animals challenged with the TS showed weakly positive reactions at challenge or re-challenge in the test group, but not in the
irritation control group: The incremental increases in ear thickness ranged from 0 - 11 %.
The test provided no evidence of a sensitising potential of 2-ethylhexylamine. The functionality of the test system was demonstrated by using an appropriate positive control substance which was clearly positive.
Despite the limited number of animals used and the test restrictions, the result can be weighed in relation to the positive control, the dose used to provoke an effect and the negative results obtained with four structure-related primary amines (cyclohexylamine, hexylamine, isopropylamine, n-octylamine).
Hence, 2-ethylhexylamine is not considered to be a potent sensitiser and unlikely to elicit a skin allergic reaction.
The mouse-ear swelling test (MEST) serves as a screen to detect potent sensitisers (moderate and strong ones). Weak sensitisers are unlikely to be detected in this test. According to EPA guideline OPPTS 870.2600, a negative result in the MEST does not indicate that the substance is a non-sensitizer, and should be confirmed in an accepted test using guinea pigs and or LLNA if appropriate.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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