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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Octanoic acid, 4-methyl-2-pentylbutyl ester
Cas Number:
868839-23-0
Molecular formula:
C18H36O2
IUPAC Name:
Octanoic acid, 4-methyl-2-pentylbutyl ester
Test material form:
liquid

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
soya oil
Duration of treatment / exposure:
90 days
Frequency of treatment:
Dose regimen: 7 days per week
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
100 mg/kg bw/day (nominal)
Dose / conc.:
300 mg/kg bw/day (nominal)
Dose / conc.:
1 000 mg/kg bw/day (nominal)
No. of animals per sex per dose:
10 per sex for each dosage group
Control animals:
yes, concurrent no treatment

Examinations

Observations and examinations performed and frequency:
Clinical Observations
One female animal dosed with 100 mg/kg bw/day of the test substance showed moderate to severe increased
drinking water consumption and diuresis from test day 40 onwards. The same animal showed pilo-erection
from test day 72-78. As this was an isolated observation this was considered not to be test related. No other
effects on behaviour or external appearance were observed in the treated animals.
Body weight changes and food consumption in the treated animals corresponded to that seen in the control
animals.
The observation and functional screening did not reveal any test item related changes at any dose level.
No test item related changes in the oestrus cycle were found at any dose level.
No test item related effects on sperm count, viability or mobility were observed.

Results and discussion

Results of examinations

Clinical signs:
effects observed, non-treatment-related
Description (incidence and severity):
No test item related changes were noted in the haematological parameters at any dose level.
No test item related changes were noted in the biochemical parameters at any dose level.
Male and female animals in the mid and high dose treatment groups showed a statistically significant decrease in the urinary pH value of between 5 and 11% which was considered to be related to treatment with the test item. The urinary specific gravity values for male rats in the mid dose group also showed a slight but statistically significant decrease, however, as it was not dose related it was considered to be unrelated to the test item.
Mortality:
mortality observed, non-treatment-related
Description (incidence):
No test item mortality occurred during the study. However, four female animals died during laboratory examinations on the last day after blood withdrawal due to ether narcosis.
Body weight and weight changes:
effects observed, non-treatment-related
Description (incidence and severity):
Animals in the high dose treatment group showed a statistically significant increase in the absolute and relative liver weights. No other test related macroscopic or microscopic changes in the organs were noted.
The changes in the liver weights were considered to be a non-specific adaptive change to the high workload of the liver at the maximum dose.
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
effects observed, non-treatment-related
Description (incidence and severity):
One female animal dosed with 100 mg/kg bw/day of the test substance showed moderate to severe increased drinking water consumption and diuresis from test day 40 onwards. The same animal showed pilo-erection from test day 72-78. As this was an isolated observation this was considered not to be test related. No other effects on behaviour or external appearance were observed in the treated animals.
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
effects observed, non-treatment-related
Description (incidence and severity):
Male and female animals in the mid and high dose treatment groups showed a statistically significant decrease in the urinary pH value of between 5 and 11% which was considered to be related to treatment with the test item.
The urinary specific gravity values for male rats in the mid dose group also showed a slight but statistically significant decrease, however, as it was not dose related it was considered to be unrelated to the test item.
The test related decrease in urinary pH is considered to be possibly due to an acidic metabolite of the test item eliminated at large doses via the urine. Therefore, in the absence of any observed effects on the kidney this is considered to be a non-adverse effect.

Behaviour (functional findings):
no effects observed
Immunological findings:
no effects observed
Organ weight findings including organ / body weight ratios:
effects observed, non-treatment-related
Description (incidence and severity):
Animals in the high dose treatment group showed a statistically significant increase in the absolute and relative liver weights. No other test related macroscopic or microscopic changes in the organs were noted.
The changes in the liver weights were considered to be a non-specific adaptive change to the high workload of the liver at the maximum dose.
Gross pathological findings:
effects observed, non-treatment-related
Neuropathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
no effects observed

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
>= 1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
body weight and weight gain
clinical biochemistry
clinical signs
gross pathology
haematology
mortality
organ weights and organ / body weight ratios
urinalysis
water consumption and compound intake

Target system / organ toxicity

Key result
Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
Propylheptyl Caprylate : NOAEL >= 1000 mg/kg bw
The No Observed Adverse Effect Level (NOAEL) was established as ≥ 1000 mg/kg bw/day in this study based on the absence of adverse treatment related effects.