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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976

Materials and methods

Principles of method if other than guideline:
10 day repeated intramuscular irritation study in rabbits.
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Decanoic acid, mixed diesters with octanoic acid and propylene glycol
EC Number:
271-516-3
EC Name:
Decanoic acid, mixed diesters with octanoic acid and propylene glycol
Cas Number:
68583-51-7
Molecular formula:
C21H44O6
IUPAC Name:
Waglinol 2/7680

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: no less than 2.5 kg

Administration / exposure

Route of administration:
intramuscular
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
no
Duration of treatment / exposure:
10 days
Frequency of treatment:
daily
Doses / concentrations
Remarks:
Doses / Concentrations:
0.6 mL
No. of animals per sex per dose:
6 (test substance group)
6 (castor oil BP group)
Control animals:
other: concurrent with castor oil BP
Details on study design:
- Two groups were concurrently tested.
- Group 1 was daily treated with the test material.
- Group 2 daily received castor oil BP.
- The injection site was clipped and the skin swapped with alcohol. The test substances were applied intramuscular into the biceps of the right hind leg of each rabbit with a sterile syringe and a 23 gauche x13/16 hypodermic needle.

Results and discussion

Results of examinations

Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Details on results:
GROSS PATHOLOGY
Group 1: Haematoma and/or haemorrhage in 5 of 6 animals, slight discolouration in 3 of 6 animals, 1 of 6 animals showed connective tissue laden with pus.
Group 2: Haematoma and/or haemorrhage in 3 of 6 animals, congestion in 2 of 6 animals, discolouration in 4 of 6 animals, inflammation in 3 of 6 animals, 2 of 6 animals showed connective tissue laden with pus.

HISTOPATHOLOGICAL
Group 1: Chronic inflammatory reaction and degenerative muscle fibres in 5 of 6 animals, in 3 of 6 animals haemorhage and giant cell granulomata were observed.
Group 2: Chronic inflammatory reaction in 5 of 6 and degenerative muscle fibres in 6 of 6 animals, in 1 of 6 animals haemorhage were observed.

UNTREATED TISSUE
All samples of the control muscle (untreated) were found to be within normal limits.

Effect levels

Dose descriptor:
dose level:
Effect level:
<= 0.24 other: mL/kg bw/day
Based on:
test mat.
Sex:
not specified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The test substance seems to be irritant to muscles and causes muscle necrosis after repeated injections. Furthermore, some giant cell grunulomate have been observed after repeated treatment. Animals similarly treated with castor oil BP showed more severe effects.