Reaction mass of Methacryloxypropyl (tris(trialkylsiloxy)silylethyl dimethylsiloxy) silane and oligomers

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

not applicable

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Deviations:

yes

Remarks:

Some minor deviations were noted but these did not have an impact on the overall conduct of the study

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

yes

Remarks:

Some minor deviations were noted but these did not have an impact on the overall conduct of the study

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1100 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

Some minor deviations were noted but these did not have an impact on the overall conduct of the study

Principles of method if other than guideline:

not applicable

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Methacryloxypropyl (tris(trialkylsiloxy)silylethyl dimethylsiloxy) silane and oligomers

EC Number:

950-463-6

Molecular formula:

C(33-81)H(86-214)O(11-25)Si(11-28)

IUPAC Name:

Reaction mass of Methacryloxypropyl (tris(trialkylsiloxy)silylethyl dimethylsiloxy) silane and oligomers

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: HES10108 (supplied as Dow Corning BY 16-122B
- Expiration date of the lot/batch: 25-August-2017 / Lot number 0008624816
- Purity test date: -14-April-2016

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: 0°C -32 °C, protected from light. Do not store with strong
oxidising agents
- Stability under test conditions: the liquid test item was tested undiluted
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

Other
- Physical state - liquid
- Color - colorless
- Active components - 95%: 3-Methacryloxypropyltris {[tris(trimethylsiloxy) silyl]
ethyldimethylsiloxy} silane
- Purity - 99.3% (non-volatile content)

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: 8-12 week sold
- Weight at study initiation: Step 1 - 200 - 201 grams and Step 2 - 153 - 181 grams
- Fasting period before study: Prior to the administration food was withheld from the test animals for 16 to 19 hours (access to water was permitted).
- Housing: The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): Free access to Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): Free access to tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water,
municipal residue control, microbiological controls at regular intervals)
- Acclimation period: Adequate acclimatisation period (at least five days) under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): Artificial light, sequence being 12 hours light, 12 hours dark

IN-LIFE DATES: From: 25-Aprill-2016 To: 25-April-2016

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

CLASS METHOD
- Rationale for the selection of the starting dose: 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:

2000 mg/kg

No. of animals per sex per dose:

3 female rats/step

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were observed for 14 days after dosing for general clinical signs , morbidity and mortality. The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes

Statistics:

not applicable

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 - 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other:

Remarks:

Under the conditions of the present study, a single oral application of the test item HES10108 to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality. The median lethal dose of HES10108 after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): > 2000 5000 mg/kg bw

Mortality:

The test item showed no mortality and no other acute oral toxicity characteristics after a single dose administration

Clinical signs:

other: The test item showed no other acute oral toxicity characteristics after a single dose administration

Gross pathology:

No specific findings were noted

Other findings:

not applicable

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study, a single oral application of the test item HES10108 to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality. The median lethal dose of HES1 01 08 after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): > 2000 5000 mg/kg body weight

Executive summary:

In this acute oral study (conducted according to OECD Guideline 423, OPPTS 870.1100 and EU Method B.1 (tris) and GLP), two groups, each of three female Wistar Crl: WI (Han) rats, were treated with the HES10108 (Dow Corning BY 16 -122B) by oral gavage administration at a dosage of 2000 mg/kg body weight, in a stepwise manner. The test item was administered undiluted according to body weight.

All animals survived until the end of the study without showing any test-item related signs of toxicity. Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain. At necropsy, no treatment-related macroscopic findings were observed in any animal of any step.

Under the conditions of the present study, a single oral application of the test item HES10108 (Dow Corning By 16 -122B) to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality. The median lethal dose of HES1 0108 after a single oral administration to female rats, observed over a period of 14 days was:

L050 cut-off (rat): > 2000 -5000 mg/kg bw