Methyl 2-((allyloxy)methyl)acrylate

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22nd August 2018 - 13th October 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 guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 403 (Acute Inhalation Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

methyl 2-[(prop-2-en-1-yloxy)methyl]prop-2-enoate

EC Number:

819-688-6

Cas Number:

219828-90-7

Molecular formula:

C8H12O3

IUPAC Name:

methyl 2-[(prop-2-en-1-yloxy)methyl]prop-2-enoate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Animal breeding facility. Jai Research Foundataion.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 9-11weeks
- Weight at study initiation: Male: 311.3g - 377.3g Female: 172.9g - 215.7g
- Fasting period before study: Not specified.
- Housing: Maximum 3 rats of same sex/cage.
- Historical data:
- Diet (e.g. ad libitum): Ad libitum.
- Water (e.g. ad libitum): Ad libitum.
- Acclimation period: 7 to 9 days. Rats were also acclimatised for a period of 4h one day prior to exposure in the rat restrainer tubes.
- Method of randomisation in assigning animals to test and control groups: The censored randomization method. (Gad and Weil, 1994)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 23°C
- Humidity (%): 55 to 66%
- Air changes (per hr): Minimum 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark maintained by an automatic timer.

IN-LIFE DATES: 22nd August 2018 - 13th October 2018

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

clean air

Mass median aerodynamic diameter (MMAD):

>= 1 - <= 4 other: microns

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Inhalation Chamber.
- Exposure chamber volume: 2.062 Liters
- Method of holding animals in test chamber: Restraint tubes.
- Source and rate of air (airflow): Dynamic air flow rate of 12 air changes per hour and ensure adequate oxygen content of at least 19%.
- System of generating particulates/aerosols: The test item will be aerolized with the help of a spray atomizer or aerosol generator.
- Method of particle size determination: Particle size analysis will be carried out using a cascade impactor by the gravimetric method.
- Temperature, humidity, pressure in air chamber: 22°C. humidity between 30 and 70%.

TEST ATMOSPHERE
- Brief description of analytical method and equipment used: Gravimetric method.
- Samples taken from breathing zone: yes



TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 1-4microns

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: Initial a study conducted with three male and three female rats. 100% mortality was observed in exposed rats at the breathing zone concentration of 5.276mg a.i/Lair, it was considered a sighting study. The full study was then conducted at three dose levels 2.407, 2.17 and 0.829 mg a.i/L air.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

4 h

Concentrations:

Breathing zone concentrations were 2.407, 2.107 and 0.829 mg a.i/L air.

No. of animals per sex per dose:

Three groups of rats, consisting of five males and five females per group used in the main study.

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice a day.
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: clinical signs, body weight, organ weights, histopathology

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LC50

Effect level:

1.087 mg/L air

Based on:

test mat.

95% CL:

> 0.776 - <= 1.523

Exp. duration:

4 h

Remarks on result:

other: This is a calculated value. Due to a mortality pattern observed, determination of a separate LC50 value for male and female rats was not possible.

Mortality:

Percent mortalities (both sexes combine) were observed 100, 90 and 30 at the breathing zone concentrations 2.407, 2.17 and 0.829 mg a.i/L air respectively.

Clinical signs:

lethargy (hypoactivity)

Body weight:

In groups 2 and 3 a decrease in body weight was noted however increased at day 14 when compared to Body weight on day 0.

Applicant's summary and conclusion

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

Percent mortalities (both sexes combine) were observed 100, 90 and 30 at the breathing zone concentrations 2.407, 2.17 and 0.829 mg a.i/L air respectively.
Based on the results of this study, an indication of the classification for FX-AO-MA is as follows:

Category 4: H332: Harmful if inhaled