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Description of key information

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.

  

In accordance with Annex VIII of REACH, Column 2, testing via inhalation is only appropriate if exposure of humans is likely. Vapour pressure of 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) was investigated during a study performed in accordance with ASTM D2879 - 97 Standard Test Method for Vapour Pressure-Temperature Relationship and Initial Decomposition Temperature of Liquids by Isoteniscope, which concluded that the substance has a vapour pressure below 100 Pa. In addition formation of aerosols during the use of the substance is unlikely. It is therefore concluded that exposure to 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) is unlikely and that it is not appropriate to investigate this route exposure.

 

In accordance with Annex VIII of REACH, Column 2, testing by the dermal route does not need to be conducted since the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and the physiological properties of the substance suggest that it does not a potential for a significant rate of absorption through the skin (see Section 7.1). 

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:
From 28 February 2018 to 27 March 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
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
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
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.
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.
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.

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

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VIII of REACH, Column 2, testing via inhalation is only appropriate if exposure of humans is likely. Vapour pressure of 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) was investigated during a study performed in accordance with ASTM D2879 - 97 Standard Test Method for Vapour Pressure-Temperature Relationship and Initial Decomposition Temperature of Liquids by Isoteniscope, which concluded that the substance has a vapour pressure below 100 Pa. In addition formation of aerosols during the use of the substance is unlikely. It is therefore concluded that exposure to 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) is unlikely and that it is not appropriate to investigate this route exposure.
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
In accordance with Annex VIII of REACH, Column 2, testing by the dermal route does not need to be conducted since the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and the physiological properties of the substance suggest that it does not a potential for a significant rate of absorption through the skin (see Section 7.1).
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

A GLP-compliant acute oral toxicity study was performed in accordance with the OECD Testing Guideline 420. It showed 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.

 

In accordance with Annex VIII of REACH, it was not required to perform acute toxicity testing via the inhalation and dermal routes as no acute toxicity is expected via these routes.