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EC number: 243-283-8 | CAS number: 19766-89-3
- 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
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- March - April 1979
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP; non guideline; minor restrictions in design but adequate for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Remarks:
- performed before GLP
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Female albino guinea pigs (Dunkin-Hartley)
bw: 300 - 400 g
Housing: 5 per cage
standard diet of guinea pig pellets and tap water, ad libitum
in life phase: 16. March to 8. April 1979 - Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction
- intradermal: 1% (w/w)
- topical: 5% (w/w) in water
challenge: 2% (w/w) in water - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction
- intradermal: 1% (w/w)
- topical: 5% (w/w) in water
challenge: 2% (w/w) in water - No. of animals per dose:
- treated group: 10
control group: 5 - Details on study design:
- RANGE FINDING TESTS: 2 guinea pigs which were pre-treated with adjuvant only at the induction phase, test substance was applied at concentrations of 10, 5, 2 and 1%. A concentration of 2% was selected as the level to be used at the challenge stage.
MAIN STUDY
A. INDUCTION EXPOSURE
treated group: 3 injections: a) 0.1 ml Freund's adjuvant alone; b) 0.1 ml 2-ethylhexoic acid (1% w/w) alone; c) 0.05 ml 2-ethylhexoic acid (1% w/w) emulsified with 0.05 ml Freund's adjuvant; 6 days after the injection phase: treatment with sodium lauryl sulphate solution (10 % w/w), after 24 h: patch of Whatman No. 3 MM filter paper saturated with 2-ethylhexoic acid (5% w/w) covered by an overlapping patch of impermeable plastlc adhesive tape for48 h
control group: injection with Freund's adjuvant alone
B. CHALLENGE EXPOSURE
treated and control group: two weeks after the topical induction: 2-ethylhexoic acid (2% w/w) was applied on a 2 x 2 cm piece of filter paper to the test site of the guinea pig. The patch was held in place for the topical induction and removed 24 h Iater.
The degree of response was determined by trained assessors 24 h after removal of the challenge patch. Positive response are rated
according to the percentage of animals sensitised (Kligman). - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2% w/w. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no data.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2% w/w
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 2% w/w. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no data.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a guinea pig maximization test 2-ethylhexanoic acid caused no allergic reaction. Therefore, 2-ethylhexanoic acid is not considered to be a skin sensitiser.
Based on a read-across approach, sodium 2-ethylhexanoate is not considered to be a skin sensitizer and is therefore not subjected for labelling and classification requirements according to regulatory requirements. - Executive summary:
A read across was performed from the source substance 2 -ethylhexanoic acid to the target substance sodium 2 -ethylhexanoate (for read across justification please refer to attached document, IUCLID Chapter 13).
Testing for sensitising properties of 2 -ethylhexanoic acid was performed in female guinea pigs according to the Guinea Pig Maximization Test. Intradermal induction was performed using 1 % 2-ethylhexanoic acid in water and topical induction using 5% 2 -ethylhexanoic acid in water. The challenge was carried out with 2% 2 -ethylhexanoic acid (epidermal) two weeks after topical induction.
2 -Ethylhexanoic acid induced no allergic reactions, and therefore, the test substance is not considered to have sensitising properties.
Based on a read-across approach, sodium 2-ethylhexanoate is not considered to be a skin sensitizer and is therefore not subjected for labelling and classification requirements according to regulatory requirements.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A read across was performed from the source substance 2 -ethylhexanoic acid to the target substance sodium 2 -ethylhexanoate (for read across justification please refer to attached document, IUCLID Chapter 13).
A valid animal study concerning sensitizing properties are available for 2-ethylhexanoic acid.
In a guinea pig maximization assay (Inveresk Research, 1979), 0/10 female Dunkin-Hartley guinea pigs exhibited a response 48 h after induction and challenge with 1% (intrdermal induction) / 5 % (topical induction) and 2 % (challenge) aqueous 2 -ethylhexanoic acid solution, respectively.
In summary, there is no evidence of a notable sensitization potential of 2 -ethylhexanoic acid.
Migrated from Short description of key information:
A guinea pig maximization assay gave no evidence of contact sensitization caused by 2-ethylhexanoic acid, the source substance of the read across approach (for read across justification please refer to the attached document, IUCLID Chapter 13).
Justification for selection of skin sensitisation endpoint:
Study design equivalent to current OECD guideline with sufficient reporting.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
2 -Ethylhexanoic acid exhibited no skin sensitising potential. Classification is not warranted according to EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Based on a read-across approach, sodium 2-ethylhexanoate is not considered to be a eye irritant and is therefore not subjected for labelling and classification requirements according to regulatory requirements.
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