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Administrative data

Description of key information

The potential acute toxic effect of the test item 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol was tested according to OECD guideline 423.  The determined LD50 in rats is greater than 2000 mg/kg bw. No adverse effect was observed.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Wistar
Remarks:
Crl:WI rats
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
Source: Toxi-Coop Zrt. 1103 Budapest, Cserkesz u. 90.
Hygienic level: SPF at arrival and kept in a good conventional environment during the study
Number of animals: 3 animals/group
Sex: Female, nulliparous and non pregnant animals
Age of animals: Young adult rats, 8 weeks old in group 1 and 2
Body weight range at starting (first step): 194-197 g
Body weight range at starting (second step): 202-204 g
Acclimatisation time: 5 days in first step and 6 days in second step

ANIMAL HUSBANDRY
Animal health: Only healthy animals were used for the study. The health status was certified by the breeder.
Number of animal room: 13/4
Housing: 3 animals/sex/cage
Cage type: Type III polypropylene/polycarbonate; rat type cages with a solid floor, stainless steel wire covers and self-feeding baskets.
Illumination: Artificial light, from 6 am. to 6 pm.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: above 10 air exchanges/hour by central air-condition system.
Temperature and relative humidity were verified and recorded daily during the study.

FOOD AND WATER SUPPLY
The animals received ssniff® SM R/M-Z+H complete diet produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany, ad libitum. The food is periodically analysed and is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
Animals received tap water from watering bottles ad libitum.
The drinking water is periodically analysed and is considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
Route of administration:
oral: gavage
Vehicle:
vegetable oil
Remarks:
Helianthi annui oleum raffinatum
Details on oral exposure:
A single oral administration - followed by a fourteen-day observation period - was performed by gavage. The day before treatment the animals were fasted. The food but not water was withheld overnight. The food was given back 3 hours after the treatment.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 females/group
Control animals:
no
Details on study design:
OBSERVATIONS
MORTALITY
Inspection for signs of morbidity and mortality were made twice daily at the beginning and end of the working day.
CLINICAL OBSERVATIONS
Animals were observed individually after dosing once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h, after the treatment and once per day for 14 days thereafter. Individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
BODY WEIGHT
The body weights were recorded on day 0 (shortly before the treatment), on day 7 and on day 15 on all animals with a precision of 1 g, respectively.
PATHOLOGY
All animals were subjected to gross pathology. All animals were exsanguinated under isoflurane anaesthesia. After examination of the external appearance the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs were observed. All gross pathological changes were recorded for each animal on the post mortem record sheets.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
All females (6/6) survived the limit dose of 2000 mg/kg bw.
Clinical signs:
No clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behaviour of experimental animals were normal.
Body weight:
The body weight development was normal in all animals.
Gross pathology:
Altogether 6 animals were subjected to scheduled sacrifice during the study.
All organs of the animals treated with 2000 mg/kg bw dose proved to be free of treatment related gross pathological changes.
Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The determined LD50 is is greater than 2000 mg/kg bw.
The test item is ranked into Globally Harmonized Classification System (GHS) Category 5 or unclassified (described in the OECD Guideline No. 423).
Executive summary:

The potential toxic effect of the test item 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol was tested according to OECD guideline 423.  For the acute oral toxicity study with the test item 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol in rats the determined LD50 is is greater than 2000 mg/kg bw.

The test item is ranked into Globally Harmonized Classification System (GHS) Category 5 or unclassified (described in the OECD Guideline No. 423).

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

Justification for classification or non-classification