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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
According to the results of valid GLP OECD Guideline studies,the source substance of this read across approach, 2-Ethylhexanoic acid, is practically non-toxic via the oral, dermal and inhalative route (for read across justification please refer to the attached document, IUCLID Chapter 13). The following values are taken into account for the risk assessment: LD50 (oral;rat): 2043 mg/kg bw; LD50 (dermal,rat) >2000 mg/kg bw; no acute toxicity from inhalative exposure to saturated vapor.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP, non-guideline, limitations in design and/or reporting
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Kingston, NY
- Age at study initiation: 8 weeks
- Weight at study initiation: 106-124 g
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 71-75
- Humidity (%): 51-52
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg b.w.
- Doses:
- 0, 90, 722, 1445, 2890 mg/kg b.w.
- No. of animals per sex per dose:
- 4
- Control animals:
- yes
- Details on study design:
- Animals were observed several times during the first 24 hours after dosing and once each workday thereafter for the duration of the test
(a total of 14 calendar days). Body weights were collected on the day of dosing and 1, 2, 3, 7, and 14 days after dosing.
All animals were necropsied . Animals which died after administration of the test article were necropsied promptly . All animals surviving the scheduled observation period were euthanetized and necropsied 14 days after test article administration. - Statistics:
- none
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 043 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 1 445 - 2 890
- Mortality:
- Dose (mg/kg b.w.):
90 mg/kg b.w.: 0/4
722 mg/kg b.w.: 0/4
1445 mg/kg b.w.: 0/4
2890 mg/kg b.w.: 4/4 - Clinical signs:
- other: weakness (90, 722, 1445 mg/kg b.w.) prostration (2890 mg/kg b.w.)
- Gross pathology:
- 90, 722 and 1445 mg/kg b.w. dose groups: no treatment-related changes were observed. No tissue was collected for microscopic examination.
2890 mg/kg b.w.: the cause of death for rats dying after exposure to the test material was not determined. Treatment-related changes consisted of compuond present in the duodenum(1/4), jejunum (3/4), ileum (3/4), cecum (4/4), colon (4/4) and fecal discoloration (1/4) and wetness (1/4) of the inguinal hair. - Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dose of 2-ethylhexanoic acid was 2043 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification according to regulatory requirements.
Based on a read-across approach, sodium 2-ethylhexanoate is not considered to be acute orally toxic 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).
2 -Ethylhexanoic aicd was tested for its acute oral toxicity potential. 4 female rats were treated with doses of 90, 722, 1445 or 2890 mg/kg bw and observed for 14 days.
The median lethal dose of test item (LD50) was 2043 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification according to regulatory requirements.
Based on a read-across approach, sodium 2-ethylhexanoate is not considered to be acute orally toxic and is therefore not subjected for labelling and classification requirements according to regulatory requirements.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 043 mg/kg bw
- Quality of whole database:
- reliable with restrictions
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Feb 1967
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study is comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981) with acceptable restrictions (partly limited documentation; post exposure observation period 7 days; low number of rats)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- Inhalation hazard test
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- other: Inhalation hazard test
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
Rats exposed for 8 h, respectively, to a vapour saturated atmosphere. Vapour was generated by bubbling 200 l/h dry air (no CO2) through the liquid substance column (volume ca. 50 ml) of about 5 cm above a fritted glass disc in a glass cylinder. The glas cylinder was heated in a water bath. Temperature in the exposure chamber was 20°C. Concentration was stated in the raw data to be 0.11 mg/l. this was calculated based on the substance loss. Base on a vapor pressure 0f 0.04 mbar and a molecular weight of 144.21 saturated vapor concentration of 2-Ethylhexanoic acid is 0.24 mg/l. Concentration of 0.11 mg/l may be regarded as reliable therefore - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 8 h
- Concentrations:
- 0.11 mg/l (nominal)
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 7 days
- Statistics:
- not necessary
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- 0.11 mg/L air (nominal)
- Exp. duration:
- 8 h
- Remarks on result:
- other: inhalation hazard test
- Mortality:
- No Mortality was observed.
- Clinical signs:
- other: no clinical signs were noted
- Body weight:
- no data
- Gross pathology:
- no substance related findings. In one animal bronchitis was detected.
- Interpretation of results:
- other: LC0 after 8 h exposure: 0.11 mg/L (saturated atmosphere)
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- The LC0 of 2-ethylhexanoic acid after 8 h inhalation exposure is 0.11 mg/L (saturated atmosphere).
Based on a read-across approach, sodium 2-ethylhexanoate is not considered to have a similar LC0 value. - 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).
6 rats/sex were exposed to an 2 -ethylhexanoic acid saturated atmosphere at a calculated concentration of 0.11 mg/L for 8 hours. No mortality or clinical signs were reported. The gross necropsy did not reveal any substance related findings.
Based on a read-across approach, sodium 2-ethylhexanoate is not considered to have a similar LC0 value.
Reference
The inhalation risk test demonstrates that there is no hazard from 2 -ethylhexanoic acid to be expected at room temperature.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- reliable with restrictions
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Oct - Nov 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF
- Age at study initiation: 7 weeks (males) 9 weeks (females
- Weight at study initiation: 208 +/- 4 g (males); 191 +/- 3 g (females
- Fasting period before study: no
- Housing: single in macrolone cages (Type 3) on wooden bedding
- Diet (e.g. ad libitum): ad libitum Altromin 1234 (Altromin GmbH, Lage/Lippe)
- Water (e.g. ad libitum): tab water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 6 x 8 cm
- % coverage:
- Type of wrap if used: alu folie, fixed by tape (Fixomull; Elastoplast; Fa. Beiersdorf)
REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.2 ml pure substance (desity 0.9 g/ml) - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation : daily; weighing prior to application on day 7 and day 17 (Study termination)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- not necessary
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- no mortality
- Clinical signs:
- other: no clinical symptoms besides eshar formation in two females from day 5-day 8
- Gross pathology:
- no substance related macroscopic findings
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The median lethal dermal dose of 2-ethylhexanoic acid wasgreater than 2000 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification according to regulatory requirements.
Based on a read-across approach, sodium 2-ethylhexanoate is not considered to be acute dermally toxic 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).
2 -Ethylhexanoic aicd was tested for its acute dermal toxicity potential. 5 female and 5 male rats were treated with 2000 mg/kg bw and observed for 14 days.
The median lethal dermal dose of test item (LD50) was greater than 2000 mg per kg body weight. Based on the result of this study the test substance is not subject for labelling and classification according to regulatory requirements.
Based on a read-across approach, sodium 2-ethylhexanoate is not considered to be acute dermally toxic and is therefore not subjected for labelling and classification requirements according to regulatory requirements.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- reliable without restrictions
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).
Valid acute toxicity studies after oral, dermal and inhalative exposure are available for 2-ethylhexanoic acid.
In an acute oral toxicity study 4 female rats/dose were dosed with 90, 722, 1445 or 2890 mg/kg bw. No mortality was observed in the 90, 722 and 1445 mg/kg bw dose groups. The test material caused mortality in rats administered a dose of 2890 mg/kg bw (4/4), and transitory weakness at lower doses in a dose-dependent manner. The LD50 was calculated to 2043 mg/kg bw.
No mortality was observed in 12 rats (6 m; 6f) after 8 h exposure to saturated 2-ethylhexanoic acid vapor in an inhalation hazard test comparable to OECD 403 Annex 1. Maximal achievable concentration in this test system was 0.11 mg/L (nominal concentration).
Dermal toxicity of 2 -ethylhexanoic acid was tested in an OECD 402 guideline study. Five Wistar rats/sex/dose have been exposed dermally (semi-occlusive) to a limit dose of 2000 mg/kg bw 2-ethylhexanoic acid. No mortality and no clinical symptoms beside eshar formation have been observed. Therefore, the dermal LD50 is > 2000 mg/kg bw.
Justification for selection of acute toxicity – oral endpoint
GLP, non-guideline, limitations in design and/or reporting
Justification for selection of acute toxicity – inhalation endpoint
Study is comparable with the inhalation hazard test described in the Annex of OECD Guideline 403 (adopted 1981) with acceptable restrictions (partly limited documentation; post exposure observation period 7 days; low number
of rats)
Justification for selection of acute toxicity – dermal endpoint
GLP Guideline study
Justification for classification or non-classification
Classification for acute toxicity is not warranted according to the criteria of EU Directive 67/548/EEC and according to 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 acute tocix and is therefore not subjected for labelling and classification requirements according to regulatory requirements.
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