(1,1,3,3-tetramethyldisiloxane-1,3-diyl)dipropane-1,3-diyl dimethacrylate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 February 2017 to 22 February 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)

Version / remarks:

2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

(1,1,3,3-tetramethyldisiloxane-1,3-diyl)dipropane-1,3-diyl dimethacrylate

EC Number:

242-419-3

EC Name:

(1,1,3,3-tetramethyldisiloxane-1,3-diyl)dipropane-1,3-diyl dimethacrylate

Cas Number:

18547-93-8

Molecular formula:

C18H34O5Si2

IUPAC Name:

1,3-Bis(3-methacryloyloxypropyl)-1,1,3,3-tetramethyldisiloxane

Test material form:

liquid

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature, protected from light
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: The test material was administered undiluted.

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No treatment of the test material before testing.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10 - 11 weeks old
- Weight at study initiation: Step 1: 184 – 198 g; Step 2: 185 – 196 g
- Fasting period before study: none
- Housing: kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Altromin 1324 maintenance diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 10 x hour
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg bw

DOSAGE PREPARATION (if unusual): Not applicable

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The test item was administered at a single dose by gavage using a feeding tube. The sample was administered according to the dose chosen at the start of the study. The starting dose was selected to be 2000 mg/kg body weight. No compound-related mortality was recorded for any animal of step 1 or 2. Based on these results and according to the acute toxic class method regime no further testing was required.

Doses:

Step 1 and 2: 2000 mg/kg bw

No. of animals per sex per dose:

3 animals per dose and step

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

Not used.

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 was no mortality after a single dose administration.

Clinical signs:

No specific findings were observed during the 14-days observation period.

Body weight:

None of the animals showed weight loss during the observation period.

Gross pathology:

No specific gross pathological changes were recorded for any animal.

Other findings:

Not applicable

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In the acute oral toxicity study with 1,1,3,3-tetramethyldisiloxane-1,3-diyl)dipropane-1,3-diyl dimethacrylate, the reported LD50 value was greater than 2000 mg/kg bw.