Registration Dossier

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:
1973
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

Constituent 1
Chemical structure
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

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