Registration Dossier
Registration Dossier
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EC number: 243-283-8 | CAS number: 19766-89-3
Acute Toxicity: inhalation
Administrative data
- 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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1967
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- 2-ethylhexanoic acid
- EC Number:
- 205-743-6
- EC Name:
- 2-ethylhexanoic acid
- Cas Number:
- 149-57-5
- IUPAC Name:
- 2-ethylhexanoic acid
- Test material form:
- other: liquid
- Details on test material:
- Name of test material (as cited in study report): alpha-Aethylhexansaeure
- Physical state: liquid
- Analytical purity: ca. 99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- 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
Results and discussion
Effect levels
- 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.
Any other information on results incl. tables
The inhalation risk test demonstrates that there is no hazard from 2 -ethylhexanoic acid to be expected at room temperature.
Applicant's summary and conclusion
- 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.
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