Reactionmass of octan-2-yl prop-2-enoate and octan-3-yl prop-2-enoate and octan-4-yl prop-2-enoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Version / remarks:

2001

Deviations:

no

Remarks:

No deviations ocurred that impacted the integrity of the study.

GLP compliance:

yes (incl. QA statement)

Test type:

up-and-down procedure

Limit test:

yes

Test material

Test material information

1

Reference substance name:

Reactionmass of octan-2-yl prop-2-enoate and octan-3-yl prop-2-enoate and octan-4-yl prop-2-enoate

EC Number:

947-155-9

Molecular formula:

C11H20O2

IUPAC Name:

Reactionmass of octan-2-yl prop-2-enoate and octan-3-yl prop-2-enoate and octan-4-yl prop-2-enoate

Test material form:

liquid

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 3M Company, Lot 11
- Purity, including information on contaminants, isomers, etc.: 99.7%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Kept in a room with controls set to maintain 18°C to 24°C

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): None, dosed neat.

FORM AS APPLIED IN THE TEST (if different from that of starting material) : The test article was dosed neat.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Inc.
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 205-244 g
- Fasting period before study: Overnight
- Housing: Animals were individually housed in stainless steel wire mesh cages equipped with an automatic watering valve.
- Diet (e.g. ad libitum): PMI Nutrition International, LLC Certified Rodent LabDiet 5002 meal was provided ad libitum
- Water (e.g. ad libitum): Municipal tap water after treatment by reverse osmosis and ultraviolet irradiation was freely available to each animal via an automatic watering system
- Acclimation period: At least five days.
- Microbiological status when known : No data.
- Method of randomisation in assigning animals to test and control groups : Randomized via a computerized randomization program.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 18 June 2019 To: 05 July 2019

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE: None, dosed neat.

MAXIMUM DOSE VOLUME APPLIED: 2.308 mL/kg body weight.

DOSAGE PREPARATION (if unusual): Neat

Doses:

2,000 mg/kg body weight.

No. of animals per sex per dose:

5 females were utilized in the study.

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed at the time of dosing and approximately 15 ± 5 minutes and 1, 2, and 4 hours postdosing on Day 1 and once daily thereafter for 14 days. Body weights were obtained and recorded on Days 1 (initiation), 8, and 15 (termination).
- Necropsy of survivors performed: yes
- Clinical signs including body weight: The rats were observed at the time of dosing and approximately 15 ± 5 minutes and 1, 2, and 4 hours postdosing on Day 1 and once daily thereafter for 14 days. Body weights were obtained and recorded on Days 1 (initiation), 8, and 15 (termination).
- Other examinations performed: clinical signs, body weight,gross necropsy

Statistics:

At the termination of the project, all data will be collected and the acute oral median lethal dose (LD50) will be determined using the EPA-provided statistical program AOT425StatPgm.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived to the scheduled necropsy.

Clinical signs:

other: There were no abnormal clinical signs observed during the study.

Gross pathology:

No test article-related observations were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of the study, the acute oral LD50 of MTDID 44428 is greater than 2,000 mg/kg body weight.

Executive summary:

The acute oral lethality of MTDID 44428 was evaluated in female Sprague Dawley rats. The study was conducted according to OECD 423 in compliance with OECD GLP. Female rats (5) were dosed neat (no vehicle) via oral gavage with 2,000 mg/kg bw MTDID 44428. The rats were observed at the time of dosing and approximately 15 ± 5 minutes and 1, 2, and 4 hours postdosing on Day 1 and once daily thereafter for 14 days. Body weights were obtained and recorded on Days 1 (initiation), 8, and 15 (termination). All rats survived with no clinical signs of toxicity and no abnormal body weight changes. No treatment-related findings were observed upon gross necropsy. Based on the results of the study, the acute oral LD50 of MTDID 44428 is greater than 2,000 mg/kg body weight.