Reaction mass of (((1,3-phenylenebis(oxy))bis(ethane-2,1-diyl))bis(oxy))bis(ethane-2,1-diyl) bis(2-methylacrylate) and (1,3-phenylenebis(oxy))bis(propane-3,1-diyl) bis(2-methylacrylate) and 3-(3-(2-(2-(methacryloyloxy)ethoxy)ethoxy)phenoxy)propyl methacrylaterate

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Deviations:

no

Remarks:

No deviations ocurred that impacted the integrity of the study.

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (((1,3-phenylenebis(oxy))bis(ethane-2,1-diyl))bis(oxy))bis(ethane-2,1-diyl) bis(2-methylacrylate) and (1,3-phenylenebis(oxy))bis(propane-3,1-diyl) bis(2-methylacrylate) and 3-(3-(2-(2-(methacryloyloxy)ethoxy)ethoxy)phenoxy)propyl methacrylaterate

EC Number:

944-271-1

Cas Number:

2305048-54-6

Molecular formula:

not applicable for multi-constituent.

IUPAC Name:

Reaction mass of (((1,3-phenylenebis(oxy))bis(ethane-2,1-diyl))bis(oxy))bis(ethane-2,1-diyl) bis(2-methylacrylate) and (1,3-phenylenebis(oxy))bis(propane-3,1-diyl) bis(2-methylacrylate) and 3-(3-(2-(2-(methacryloyloxy)ethoxy)ethoxy)phenoxy)propyl methacrylaterate

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, Batch 653940
- Purity, including information on contaminants, isomers, etc.: No data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature.
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage: Stable for the duration of the study.
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis: No data.
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: No data.
- Reactivity of the test material with the incubation material used (e.g. plastic ware): No data.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing (e.g. warming, grinding): Test article was solubilized in PEG 400.
- Preliminary purification step (if any): None.

FORM AS APPLIED IN THE TEST: Solubilized in PEG 400.

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hilltop Lab Animals, Inc.
- Females (if applicable) nulliparous and non-pregnant: [yes/no] No
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 201 grams to 236 grams.
- Fasting period before study: The food for each rat will be removed from each cage 16-20 hours prior to dosing
- Housing: The animal housing room temperature and relative humidity were monitored daily. The temperature for the room was set to 68-79°F and the relative humidity was set to 30-70%. There were no significant temperature or relative humidity excursions that adversely affected the health of the animals.
- Historical data: Contract lab records historical control animal data.
- Diet (e.g. ad libitum): A commercially available rodent feed, PRO LAB RMH 1000 - 5P07, was provided daily.
- Water (e.g. ad libitum): Potable water was provided ad libitum through
species appropriate water containers or delivered through an automatic watering system.
- Acclimation period: Minimum 5 days.
- Microbiological status when known : Only healthy animals used.
- Method of randomisation in assigning animals to test and control groups: No data.

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68-79 F
- Humidity (%): 30-70
- Air changes (per hr): No data.
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark.

IN-LIFE DATES: From: To: 8/9/2017 to 8/16/2017.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: PEG 400

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 400 mg/ml
- Amount of vehicle (if gavage): 5mL/Kg
- Justification for choice of vehicle:Test article solubility and test system compatibility.
- Lot/batch no. (if required): No data.
- Purity: No data.

MAXIMUM DOSE VOLUME APPLIED: 5 mL/Kg BW

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:Per OECD 423.

Doses:

0 and 2000 mg/kg.

No. of animals per sex per dose:

3 female rats per dose.

Control animals:

yes

Details on study design:

- Frequency of observations and weighing: weighed at day 7 and day 14. Observed daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

No data.

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No.

Clinical signs:

other: No toxicologically-relevant clinical signs were observed in the study.

Gross pathology:

No toxicologically-relevant findings were observed upon necropsy.

Other findings:

None.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Acute oral exposure to 2,000 mg/kg BW of DiBrORMA did not result in mortality or evidence of toxicity in the rats. The LD50 for the study was reported to be >2000 mg/kg BW.

Executive summary:

The acute oral toxicity of DiBrORMA(Lot: 653940) was tested in Hla (sprague dawley) rats. The study was conducted according to GLP. The test method was conducted based on the OECD Guideline no. 423 (2001).The study utilized female rats (3 per test and control group). The test article was diluted with Polyethylene glycol 400 (PEG) to 400 mg/mL. The control (PEG) was dosed as received. The control vehicle was clear, colorless with no particulates. The food for each rat was removed from each cage 16-20 hours prior to dosing and each animal was then weighed. The test or vehicle control article was administered orally once on study Day 1 via a stainless steel blunt tipped cannula attached to a graduated disposable syringe. Vehicle control (Group 1) animals were administered first, followed by the highest dose of test article (2,000 mg/kg) for animals designated in Group 2. Animals were observed immediately after dosing, 30 minutes, 1 hour, 2 hours, 3 hours, and 4 hours after dosing and daily. Food was returned following the immediate observation. The rats were again weighed at day 7 and day 14 of the study. Rats euthanized by carbon dioxide inhalation at day 14 were subjected to a gross macroscopic examination of the viscera. All animals survived the study. No adverse body weight changes or toxicologically-relevant clinical signs were observed in the study. No relevant findings were observed upon necropsy. Acute oral exposure to2,000 mg/kg BW of DiBrORMAdid not result in mortality or evidence of toxicity in the rats. The LD₅₀ for the study was reported to be >2000 mg/kg BW.