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EC number: 240-354-5 | CAS number: 16230-35-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 15, 2016 - December 6, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- N,N'-(ethoxymethylsilylene)bis[N-methylbenzamide]
- EC Number:
- 240-354-5
- EC Name:
- N,N'-(ethoxymethylsilylene)bis[N-methylbenzamide]
- Cas Number:
- 16230-35-6
- Molecular formula:
- C19H24N2O3Si
- IUPAC Name:
- N,N'-[ethoxy(methyl)silanediyl]bis(N-methylbenzamide)
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage JANVIER LABS (F-53941 Le genest St. Isle)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8-9 weeks old
- Weight at study initiation: Step 1: 203 ± 7.0; Step 2 and 3: 214.8 ± 6.3
- Fasting period before study: overnight
- Housing: Rats were housed by group of three in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains sawdust bedding which was changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry.
- Diet: foodstuff (ENVIGO - 2016) ad libitum
- Water: tap-water from public distribution system ad libitum. Microbiological and chemical analyses of the water were carried out once every six months by Bureau Veritas-eurofins (France)
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19ºC - 25ºC
- Humidity (%): 30% - 70%
- Air changes (per hr): Ten changes per hour
- Photoperiod (hrs dark / hrs light): Twelve hours light (07.00 to 19.00) / twelve hours darkness.
IN-LIFE DATES: From: November 15, 2016 To: December 6, 2016
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: In first step, test item was administered corresponding to 2g/kg, according to the calculated density. In second and third step, 0.27 mL of the test item (corresponding to 300 mg) were added to 1.54 mL of olive oil.
- Amount of vehicle (if gavage): 1.81 mL/kg.
- Justification for choice of vehicle: it produced the most suitable formulation at the requested concentration.
MAXIMUM DOSE VOLUME APPLIED: 1.81 mL/kg.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Whitout preliminary information. The selected starting dose is 2000 mg/kg body weight. - Doses:
- 2000 mg/kg, 300 mg/kg
- No. of animals per sex per dose:
- 3 (Step 1)
6 (Step 2) - Control animals:
- yes
- Remarks:
- Study No. TAO423-2016-005 (see "Other information on results").
- Details on study design:
- - Duration of observation period following administration: 14 days .
- Frequency of observations and weighing: Systemic observations at 30 min, 1h, 3h, 4h, 24h, 48h after administration and daily during 14 days. Weighing: on Day 0 (just before administering the test item) then on Day 2, Day 7, and Day 14.
- Necropsy of survivors performed: yes.
At the end of the study, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels. Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. No organ was removed and preserved in view to microscopic examinations.
- Other examinations performed:
Body weight and body weight gain: the animals were weighted on D0 (just before administering the test item) then on D2, D7, and D14.
Clinical signs: Spontaneous activity, Preyer's reflex (noise), Respiratory rate, Convulsions, Tremors, Body temperature, Muscle tone, Palpebral opening, Pupil appearance, Salivation, Lachrymation, Righting reflex, Back hair appearance, Mortality.
Gross pathology: On D14, the animals were anaesthetised with sodium pentobarbital and administration continued to fatal levels. Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. Parameters examined: Oesophagus, Stomach, Duodenum, Jejunum, Ileon, Caecum, Colon, Rectum, Spleen, Liver, Thymus, Trachea, Lungs, Heart, Kidneys, Urinary Bladder, Ovaries, Uterus, Treatment Area, Adrenals and Pancreas.
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- ca. 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- At the dose of 2000 mg/kg bw, all three animals died (3/3), two at 24 hours post dose and one other at 48 hours post dose.
No mortality occurred during the study at the dose of 300 mg/kg. - Clinical signs:
- At 2000 mg/kg bw: the mortalities were preceded by an absence or decrease in spontaneous activity (3/3), muscles tones (3/3), righting reflex (3/3), Preyer's reflex (3/3), associated with bradypnea (3/3), dyspnea (1/3), hypothermia (3/3), eyes partly (2/3) or totally (2/3) closed, mydriasis (3/3), an increase of salivation (1/3) and piloerection (1/3). Rigor mortis were noted before the necropsy (3/3).
At 300 mg/kg bw: no clinical signs related to the administration of the test item were observed during the study. - Body weight:
- At 300 mg/kg bw: the body weight evolution of the animals remained normal throughout the study.
- Gross pathology:
- At 2000 mg/kg bw: the macroscopic examination of the animals revealed a thinning of a forestomach and corpus (1/3), a swelling of the stomach (2/3), red coloration of a forestomach and corpus (2/3). Furthermore, cellular lysis of main organs in the abdomen was noted (2/3).
At 300 mg/kg bw: the macroscopic examination of the animals at the end of the study did not reveal treatment related changes.
Any other information on results incl. tables
Clinical observations:
Dose 2000 mg/kg bw: results in Tables 1 to 6.
Dose 300 mg/kg bw: all the observations were Normal during the first 4 hours after administration of the test item, and then 14 days after.
Body weight evolution:
Dose 2000 mg/kg bw: results in Table 7.
Dose 300 mg/kg bw: results in Table 8.
Macroscopical examinations:
Dose 2000 mg/kg bw: necropsy data sheets (Tables 9 and 10).
Dose 300 mg/kg bw: nothing to report.
Table 1. Test item at 2000 mg/kg bw. Observation data sheet.
OBSERVATIONS: |
FEMALES |
||
T0 + 30 minutes |
Rf 0709 |
Rf 0710 |
Rf 0711 |
Spontaneous activity |
D |
0 |
D |
Preyer’s réflex (noise) |
D |
0 |
D |
Repiratory rate |
N |
N |
N |
convulsions |
N |
N |
N |
tremors |
N |
N |
N |
Body temperature |
N |
N |
N |
Muscle tone |
N |
0 |
D |
Palpebral opening |
N |
N |
N |
Pupil appearance |
N |
Md |
Md |
Salivation |
N |
N |
N |
Lachrymation |
N |
N |
N |
Ringhting reflex |
N |
0 |
D |
Back hair appearance |
N |
N |
N |
MORTALITY |
0 |
0 |
0 |
Remarks |
None |
N: Normal / None (Convulsions, Tremors)
Md: Mydriasis
D: Decreased / limited (Righting reflex) / Hypothermia (Body temperature)
0: None
Table 2. Test item at 2000 mg/kg bw. Observation data sheet.
OBSERVATIONS: |
FEMALES |
||
T0 + 1 hour |
Rf 0709 |
Rf 0710 |
Rf 0711 |
Spontaneous activity |
0 |
0 |
0 |
Preyer’s réflex (noise) |
0 |
0 |
0 |
Repiratory rate |
B |
B |
B |
convulsions |
N |
N |
N |
tremors |
N |
N |
N |
Body temperature |
N |
D |
N |
Muscle tone |
D |
0 |
D |
Palpebral opening |
N |
Cc |
Pc |
Pupil appearance |
Md |
Md |
Md |
Salivation |
N |
N |
N |
Lachrymation |
N |
N |
N |
Ringhting reflex |
D |
0 |
D |
Back hair appearance |
N |
N |
N |
MORTALITY |
0 |
0 |
0 |
Remarks |
None |
N: Normal / None (Convulsions, Tremors)
B: Bradypnea
Cc: Eyes completely closed
Pc. Eyes partly closed
Md: Mydriasis
D: Decreased / limited (Righting reflex) / Hypothermia (Body temperature)
0: None
Table 3. Test item at 2000 mg/kg bw. Observation data sheet.
OBSERVATIONS: |
FEMALES |
||
T0 + 3 hours |
Rf 0709 |
Rf 0710 |
Rf 0711 |
Spontaneous activity |
0 |
0 |
0 |
Preyer’s réflex (noise) |
0 |
0 |
0 |
Repiratory rate |
B |
B |
B |
convulsions |
N |
N |
N |
tremors |
N |
N |
N |
Body temperature |
D |
D |
D |
Muscle tone |
0 |
0 |
0 |
Palpebral opening |
Pc |
Cc |
Cc |
Pupil appearance |
Md |
Md |
Md |
Salivation |
N |
N |
N |
Lachrymation |
N |
N |
N |
Ringhting reflex |
0 |
0 |
0 |
Back hair appearance |
N |
N |
N |
MORTALITY |
0 |
0 |
0 |
Remarks |
None |
N: Normal / None (Convulsions, Tremors)
B: Bradypnea
Cc: Eyes completely closed
Pc. Eyes partly closed
Md: Mydriasis
D: Decreased / limited (Righting reflex) / Hypothermia (Body temperature)
0: None
Table 4. Test item at 2000 mg/kg bw. Observation data sheet.
OBSERVATIONS: |
FEMALES |
||
T0 + 4 hours |
Rf 0709 |
Rf 0710 |
Rf 0711 |
Spontaneous activity |
0 |
0 |
0 |
Preyer’s réflex (noise) |
0 |
0 |
0 |
Repiratory rate |
B |
B |
B |
convulsions |
N |
N |
N |
tremors |
N |
N |
N |
Body temperature |
D |
D |
D |
Muscle tone |
0 |
0 |
0 |
Palpebral opening |
Pc |
Cc |
Cc |
Pupil appearance |
Md |
Md |
Md |
Salivation |
N |
N |
N |
Lachrymation |
N |
N |
N |
Ringhting reflex |
0 |
0 |
0 |
Back hair appearance |
N |
N |
N |
MORTALITY |
0 |
0 |
0 |
Remarks |
None |
N: Normal / None (Convulsions, Tremors)
B: Bradypnea
Cc: Eyes completely closed
Pc. Eyes partly closed
Md: Mydriasis
D: Decreased / limited (Righting reflex) / Hypothermia (Body temperature)
0: None
Table 5. Test item at 2000 mg/kg bw. Observation data sheet.
OBSERVATIONS: |
FEMALES |
||
D1 |
Rf 0709 |
Rf 0710 |
Rf 0711 |
Spontaneous activity |
0 |
|
|
Preyer’s réflex (noise) |
0 |
|
|
Repiratory rate |
B |
|
|
convulsions |
N |
|
|
tremors |
N |
|
|
Body temperature |
D |
|
|
Muscle tone |
0 |
|
|
Palpebral opening |
Pc |
|
|
Pupil appearance |
N |
|
|
Salivation |
A |
|
|
Lachrymation |
A |
|
|
Ringhting reflex |
0 |
|
|
Back hair appearance |
Pi |
|
|
MORTALITY |
0 |
1 |
1 |
Remarks |
Rf0710 & Rf0711: found dead at T0 + 22 hours and 39 minutes |
N: Normal / None (Convulsions, Tremors)
A: Increased
B: Bradypnea
Cc: Eyes completely closed
Pc. Eyes partly closed
Pi: Piloerection
D: Decreased / limited (Righting reflex) / Hypothermia (Body temperature)
0: None
Table 6. Test item at 2000 mg/kg bw. Observation data sheet.
OBSERVATIONS: |
FEMALES |
||
D1 |
Rf 0709 |
Rf 0710 |
Rf 0711 |
Spontaneous activity |
|
|
|
Preyer’s réflex (noise) |
|
|
|
Repiratory rate |
|
|
|
convulsions |
|
|
|
tremors |
|
|
|
Body temperature |
|
|
|
Muscle tone |
|
|
|
Palpebral opening |
|
|
|
Pupil appearance |
|
|
|
Salivation |
|
|
|
Lachrymation |
|
|
|
Ringhting reflex |
|
|
|
Back hair appearance |
|
|
|
MORTALITY |
1 |
|
|
Remarks |
Rf0709: found dead on day 2 |
Table 7. Test item at 2000 mg/kg bw. Body weight and weight gain in grams.
FEMALES |
D0 |
D2 |
D2-D0 |
D7 |
D7-D0 |
D14 |
D14-D0 |
||||
Rf 0709 |
208 |
† |
|
|
|
|
|
||||
Rf 0710 |
206 |
† |
|
|
|
|
|
||||
Rf 0711 |
195 |
† |
|
|
|
|
|
||||
MEAN |
203.0 |
|
|
|
|
|
|
||||
Standard deviation |
7.0 |
|
|
|
|
|
|
||||
†: animal found dead.
Table 8. Test item at 300 mg/kg bw. Body weight and weight gain in grams.
FEMALES |
D0 |
D2 |
D2-D0 |
D7 |
D7-D0 |
D14 |
D14-D0 |
||||
Rf 0721 |
214 |
224 |
10 |
266 |
52 |
282 |
68 |
||||
Rf0722 |
213 |
220 |
7 |
250 |
37 |
278 |
65 |
||||
Rf 0723 |
206 |
214 |
8 |
244 |
38 |
256 |
50 |
||||
Rf 0738 |
220 |
235 |
15 |
251 |
31 |
275 |
55 |
||||
Rf 0739 |
212 |
227 |
15 |
254 |
42 |
258 |
46 |
||||
Rf 0740 |
224 |
242 |
18 |
269 |
45 |
279 |
55 |
||||
MEAN |
214.8 |
227.0 |
12.2 |
255.7 |
40.8 |
271.3 |
56.5 |
||||
Standard deviation |
6.3 |
10.2 |
4.4 |
9.8 |
7.3 |
11.3 |
8.5 |
||||
Table 9. Necropsy data sheet of rats Rf0710 to Rf0711 (16 November 2016)
Found dead: X
|
Euthanasia:
|
At term:
|
GENERAL APPEARANCE BEFORE AUTOPSY: Rigor mortis, found dead at T0 + 22 hours and 39 minutes
|
||
|
Observed Organs
|
Observations
|
* OESOPHAGUS |
X |
N.t.R. |
* STOMACH |
X |
Forestomach 6 corpus red colored, swollen stomach |
* DUODENUM |
- |
Cell lysis |
* JEJUNUM |
- |
Cell lysis |
* ILEON |
- |
Cell lysis |
* CAECUM |
- |
Cell lysis |
* COLON |
- |
Cell lysis |
* RECTUM |
- |
Cell lysis |
* SPLEEN |
- |
Cell lysis |
* LIVER |
X |
N.t.R. |
* THYMUS |
X |
N.t.R. |
* TRACHEA |
X |
N.t.R. |
* LUNGS |
X |
N.t.R. |
* HEART |
X |
N.t.R. |
* KIDNEYS |
X |
N.t.R. |
* URINARY BLADDER |
X |
N.t.R. |
* OVARIES |
X |
N.t.R. |
* UTERUS |
X |
N.t.R. |
* TREATMENT AREA |
- |
- |
* ADRENALS |
X |
N.t.R. |
* PANCREAS |
X |
N.t.R. |
PARTICULARS. None
|
N.t.R.: Nothing to report
Table 10. Necropsy data sheet of rat Rf0709 (17 November 2016)
Found dead: X
|
Euthanasia:
|
At term:
|
GENERAL APPEARANCE BEFORE AUTOPSY: Rigor mortis, found dead on day 2
|
||
|
Observed Organs
|
Observations
|
* OESOPHAGUS |
X |
N.t.R. |
* STOMACH |
X |
Thickening of the forestomach and the corpus |
* DUODENUM |
X |
N.t.R. |
* JEJUNUM |
X |
N.t.R. |
* ILEON |
X |
N.t.R. |
* CAECUM |
X |
N.t.R. |
* COLON |
X |
N.t.R. |
* RECTUM |
X |
N.t.R. |
* SPLEEN |
X |
N.t.R. |
* LIVER |
X |
N.t.R. |
* THYMUS |
X |
N.t.R. |
* TRACHEA |
X |
N.t.R. |
* LUNGS |
X |
N.t.R. |
* HEART |
X |
N.t.R. |
* KIDNEYS |
X |
N.t.R. |
* URINARY BLADDER |
X |
N.t.R. |
* OVARIES |
X |
N.t.R. |
* UTERUS |
X |
N.t.R. |
* TREATMENT AREA |
- |
- |
* ADRENALS |
X |
N.t.R. |
* PANCREAS |
X |
N.t.R. |
PARTICULARS. Body weight: 194 g
|
N.t.R.: Nothing to report
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The LD50 of the test item is higher than 300 mg/kg bw and lower than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off of the test item may be considered as 500 mg/kg body weight by oral route in the rat.
- Executive summary:
The acute oral toxicity of the test item has been tested in accordance with OECD 423 and EU method B.1 tris, following GLP. The test item was administered, as supplied, to a group of 3 female Sprague-Dawley rats at the dose of 2000 mg/kg and 6 female Sprague-dawley rats at the dose of 300 mg/kg body weitght by oral gavage. At the highest dose, all three animals died (3/3), two at 24 hours post dose and one other at 48 hours post dose. The mortalities were preceded by an absence or decrease in spontaneous activity (3/3), muscles tones (3/3), righting reflex (3/3), Preyer's reflex (3/3), associated with bradypnea (3/3), dyspnea (1/3), hypothermia (3/3), eyes partly (2/3) or totally (2/3) closed, mydriasis (3/3), an increase of salivation (1/3) and piloerection (1/3). Rigor mortis were noted before the necropsy (3/3). The macroscopic examination of the animals revealed a thinning of a forestomach and corpus (1/3), a swelling of the stomach (2/3), red coloration of a forestomach and corpus (2/3). Furthermore, cellular lysis of main organs in the abdomen was noted (2/3). At the dose of 300 mg/kg, no mortality occurred during the study and the body weight evolution of the animals remained normal during the study. Furthermore, no clinical signs related to the administration of the test item were observed during the study. The macroscopic examination of the animals at the end of the study did not reveal treatment related changes. The LD50 of the test item is higher than 300 mg/kg bw and lower than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off of the test item may be considered as 500 mg/kg body weight by oral route in the rat. Based on the available information, the test item has to be classified in category 4 according to CLP Regulation (EC) no. 1272/2008.
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