Registration Dossier
Registration Dossier
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EC number: 939-270-8 | CAS number: -
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only short abstrat available (intramuscular injection))
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- To evaluated if Eutanol G is suitable for use as dissolving aid for pharmaceutical preparations intended for intramuscular injection, its local compatibility was examined after intramuscular injection.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-octyldodecan-1-ol
- EC Number:
- 226-242-9
- EC Name:
- 2-octyldodecan-1-ol
- Cas Number:
- 5333-42-6
- Molecular formula:
- C20H42O
- IUPAC Name:
- 2-octyldodecan-1-ol
- Details on test material:
- - Name of test material (as cited in study report): Eutanol G
No additional details provided
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No details provided
Administration / exposure
- Route of administration:
- intramuscular
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- The test substance was injected into the upper hind leg of each of a group of 4 test animals.
- Doses:
- 0.3 mL
- No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 3 days
After 3 days, the animals were killed and dissections of the treated areas were made - Statistics:
- None
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- other: irritancy caused by intramuscular injection
- Effect level:
- > 0.3 other: mL/animal
- Based on:
- test mat.
- Remarks on result:
- other: The treatment was tolerated by all animals without visible reactions.
- Mortality:
- No mortality was reported
- Clinical signs:
- The treatment was tolerated by all animals without visible reactions.
- Body weight:
- No data
- Gross pathology:
- No pathological reactions were observed at dissection
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.
