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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 28 February 2018 to 27 March 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
2-Propenoic acid, 2-methyl-, tetracosyl ester, branched
EC Number:
292-146-9
EC Name:
2-Propenoic acid, 2-methyl-, tetracosyl ester, branched
Cas Number:
90552-24-2
Molecular formula:
C28H54O2
IUPAC Name:
2-Propenoic acid, 2-methyl-, tetracosyl ester(branched)
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Envigo RMS (UK) Limited, Oxon, UK
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 166 g to 189 g
- Fasting period before study: Food removed overnight prior to dosing and returned approximately 3 to 4 hours after dosing
- Housing: Housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes
- Diet: 2014C Teklad Global Rodent diet ad libitum)
- Water: ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least fifteen air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 30 mg/mL
- Justification for choice of vehicle: Arachis oil BP was used because the test item did not dissolve/suspend in distilled water.

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
Doses:
300 mg/kg bw was chosen as the starting dose.
In the absence of mortality or clear evident toxicity at a dose level of 300 mg/kg, additional testing was performed at 2,000 mg/kg bw.
No. of animals per sex per dose:
One animal at 300 mg/kg bw.
Five animals at 2,000 mg/kg bw.
Control animals:
no
Details on study design:
- Duration of observation period following administration: Fourteen days
- Frequency of observations: Morbidity / mortality inspection occurred twice daily, early and late, during a normal working day and once daily at weekends and public holidays.
- Necropsy of survivors performed: At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Other examinations performed: Body weights were recorded on day 0 (prior to dosing), 7, and 14, or at death. Clinical observations were performed 30 minutes and 1, 2, and 4 hours after dosing, then at least once daily for 14 days.

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths.
Clinical signs:
Hunched posture was noted in one animal during the day of dosing. Four animals appeared normal throughout the observation period.
Body weight:
All animals showed expected gains in body weight over the observation period.
Gross pathology:
No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Following an acute oral toxicity experiment in rats, it was determined that 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) was not acutely toxic via the oral route under the conditions of the study. No mortality was observed at the highest dose over a 14-day period, therefore the LD50 is concluded to be >2000 mg/kg bw. The substance does not meet the criteria for classification according to Regulation 1272/2008.
Executive summary:

The acute toxicity of 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) via the oral route was evaluated during a study performed according to the OECD Testing Guideline 420. The study was GLP-compliant.

The fixed dose method was used. One female Wistar rat received by gavage a single dose of 300 mg/kg bw in arachis oil. In the absence of observable toxicity at 300 mg/kg bw, an animal was treated at 2,000 mg/kg bw (undiluted). Considering that no mortality or clear signs of toxicity were observed, four additional female Wistar rats were treated at 2,000 mg/kg bw.

Following exposure to the test substance, animals were observed for 14 days. Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily until the end of the observation period. Morbidity and mortality checks were made twice daily, early and late during normal working days, and once daily at weekends and public holidays. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14. At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

No deaths occurred as a result to treatment. Hunched posture was noted in one animal during the day of dosing at 2,000 mg/kg bw. All animals showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy.

It can be concluded that2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) has a LD50 > 2,000 mg/kg bw via the oral route.