Registration Dossier

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:
1996
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
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%

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.