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Description of key information

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

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Qualifier:
according to
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
Qualifier:
according to
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
Qualifier:
according to
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
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)
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals 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
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
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:
The test item showed no other acute oral toxicity characteristics after a single dose administration
Body weight:
None of the animals showed weight loss during the observation period
Gross pathology:
No specific findings were noted
Other findings:
not applicable
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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
Klimisch score 1

Additional information

Justification for classification or non-classification

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 and hence does not meet the criteria for classification for acute toxicity via the oral route