Registration Dossier
Registration Dossier
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EC number: 304-059-6 | CAS number: 94233-27-9
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- 2-ethylhexanol and pentane-2,4-dione are two main hydrolysis prodcuts of the target substance. Properties of the the two substance are used for read-across.
Data source
Reference
- Reference Type:
- publication
- Title:
- Subchronic inhalation toxicity study of 2-ethylhexanol vapour in rats
- Author:
- Klimisch, H.-J.; Deckardt, K.; Gembardt, C.; Hildebrand, B.
- Year:
- 1 998
- Bibliographic source:
- Food and Chemical Toxicology, 36, 1998, 165-168
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 2-ethylhexan-1-ol
- EC Number:
- 203-234-3
- EC Name:
- 2-ethylhexan-1-ol
- Cas Number:
- 104-76-7
- Molecular formula:
- C8H18O
- IUPAC Name:
- 2-ethylhexan-1-ol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Duration of treatment / exposure:
- 90 days.
- Frequency of treatment:
- 6 hours/day, 5 days/week.
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 ppm (nominal)
- Dose / conc.:
- 15 ppm (nominal)
- Dose / conc.:
- 40 ppm (nominal)
- Dose / conc.:
- 120 ppm (nominal)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Other effects:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 120 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effect
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No adverse effects were seen in this 90 day inhalation toxicity study (OECD TG 413) in male and female WIstar rats tested up to concentrations of 120 ppm (which was equivalent to saturation at 20°C according to the study authors). Thus the NOAELof this study was 120 ppm, i.e. 638.4 mg/m3.
- Executive summary:
As the target substance hydrolyses rapidly (half-life < 30 minutes) the intrinsic properties are related to hydrolysis products of the target substance. This information is used as a supporting evidence on the toxicity of the target substance in CSA.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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