Registration Dossier
Registration Dossier
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EC number: 246-665-2 | CAS number: 25151-96-6
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (limited parameters examined, no daily observation, no data on test substance purity)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Deviations:
- yes
- Remarks:
- (limited parameters examined, no daily observation)
- GLP compliance:
- no
Test material
- Reference substance name:
- Fatty acids, C5-9, tetraesters with pentaerythritol
- EC Number:
- 267-022-2
- EC Name:
- Fatty acids, C5-9, tetraesters with pentaerythritol
- Cas Number:
- 67762-53-2
- IUPAC Name:
- 67762-53-2
- Details on test material:
- - Name of test material (as cited in study report): [Trade name]
- Physical state/appearance: yellow liquid
- Analytical purity: no data
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: 1.0 µm/ approx. 1.8
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 6 hours/day
5 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.00 ± 0.00, 0.05 ± 0.01, 0.17 ± 0.01, and 0.56 ± 0.02 mg/L
Basis:
analytical conc.
- Remarks:
- Doses / Concentrations:
0.05, 0.15, and 0.5 mg/L
Basis:
nominal conc.
- No. of animals per sex per dose:
- 15
(Additional 10 male rats per group were included for examination of pulmonary function tests and analysis of pulmonary hydroxyproline following exposure.) - Control animals:
- yes, concurrent no treatment
- yes, sham-exposed
Results and discussion
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 0.5 mg/L air (analytical)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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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