Registration Dossier
Registration Dossier
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EC number: 246-665-2 | CAS number: 25151-96-6
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 09 Jul - 10 Oct 1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (no data on test substance purity; only 2 dose groups, open application, limited parameters examined)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
- Deviations:
- yes
- Remarks:
- (no data on test substance purity, only 2 dose groups, open application, limited parameters examined)
- GLP compliance:
- no
- Limit test:
- 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]
- Substance type: polyol ester
- Physical state/appearance: light yellow liquid
- Analytical purity: no data
- Relative density: 1.00
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days per week (65 exposures), 24 hours/day, removal of substance on saturdays (once a week)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
800 and 2000 mg/kg bw/day
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 10
(5 additional animals of the control and the high dose group were included for dermal bioavailability experiments only.) - Control animals:
- yes, concurrent no treatment
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 2 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: highest dose tested
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
