Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
19.01.2015 - 19.02.2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed according to international accepted testing guideline, well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Isocarb 24
- Substance type: Product
- Lot/batch No.: ISC2403, 04058/MA
- Physical state: crystalline at ambient conditions

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: 10-12 weeks
- Weight at study initiation: female: 155 - 171 g
- Fasting period before study: 16 - 19 h (access to water was permitted)
- Housing: in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 02102140831)
- Diet: ad libitum, Altromin 1324 maintenance diet for rats and mice (lot no. 1239)
- Water: ad libitum, tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least 5 days
The animals were non-pregnant and nulliparous.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10x
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
cotton seed oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 0.2 g/ml
- Amount of vehicle (if gavage):10 mL/kg bw
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characterics
- Lot/batch no. (if required): Sigma, lot no. MKBQ546V, expiry date: 31 March 2015
- Purity: not mentioned

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw

DOSAGE PREPARATION: 2 g of the test item were suspended in 10 mL of the vehicle. Test item in the vehicle was maintained by vortexing the prepared suspension thoroughly before each dose administration.

CLASS METHOD
- Rationale for the selection of the starting dose: The starting dose was selected to be 2000 mg/kg bw, no toxicity was expected.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (3 in each of 2 steps)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A careful clinical examination was made several times on the day of dosing (at least once) during the first 30 minutes and with special attention given during the first 4 hours post-dose. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded. Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma. The animals were weighed on day 1 prior to the administration and on days 8 and 15.
- Necropsy of survivors performed: yes, at the end of the observation period the animals were sacrified by an over-dosage of phenobarbital injected intraperitoneally.
Statistics:
not performed

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred throughout the study.
Clinical signs:
No specific findings.
Body weight:
None of the animals showed weight loss during the observation period.
Gross pathology:
With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No animal died. In the study performed the dosis letalis media (LD50) to rats was found to be > 2000 mg/kg bodyweight.
Executive summary:

Under the conditions of the present study, a single oral application of the test item 2 -decyltetradecanoic acid to rats at a dose 2000 mg/kg body weight was associated with no signs of toxicity or mortality. The median lethal dose of 2 -decyltetradecanoic acid after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): >5000 mg/ kg body weight.