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EC number: 601-747-0 | CAS number: 120939-52-8
- 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:
- 29 June to 21 July 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2023
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- Dec 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- N-{3-[Dimethoxy(methyl)silyl]propyl}butan-1-amine
- EC Number:
- 601-747-0
- Cas Number:
- 120939-52-8
- Molecular formula:
- C10H25NO2Si
- IUPAC Name:
- N-{3-[Dimethoxy(methyl)silyl]propyl}butan-1-amine
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl: WI(Han) (full barrier)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Step 1: 8 - 9 weeks; Step 2: 9 - 10 weeks
- Weight at study initiation: Step 1: 155 - 167 g; Step 2: 166 - 176 g
- Fasting period before study: yes, prior to the administration food was withheld from the test animals for 16 to 18 hours (access to water was permitted). Food was provided again approximately 3 hours post dosing.
- Housing: group housed in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding.
- Diet: Altromin 1324 maintenance diet for rats and mice (Altromin Spezialfutter GmbH & Co. KG, Lage, Germany), ad libitum.
- Water: tap water, sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals), ad libitum.
- Acclimation period: Step 1: 6 days; Step 2: 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 2000 mg/kg bw (Step 1 and Step 2)
- No. of animals per sex per dose:
- Step 1: 3 females at 2000 mg/kg bw
Step 2: 3 females at 2000 mg/kg bw - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: a careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.
The animals were weighed on Day 1 (prior to the administration) and on Days 8 and 15.
- Clinical signs: cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Step 1: one animal was found dead on the day of treatment (5.5 hours post-dose).
Step 2: one animal was found dead on the day of treatment (3 hours post-dose).
See Table 3 for details of the LD50 cut-off value. - Clinical signs:
- other:
- Body weight:
- other body weight observations
- Remarks:
- None of the animals showed weight loss during the observation period (see Table 2 for details).
- Gross pathology:
- No specific gross pathological changes were recorded for any animal.
Any other information on results incl. tables
Table 1: Clinical Signs - Individual Data
Step | Animal No. / Sex | Starting Dose (mg/kg bw) | Time of Observation | Observations |
1 | 1, 2 / female | 2000 | 0 min – Day 15 | nsf |
3 / female | 2000 | 0 min – 240 min | nsf | |
334 min | Animal found dead | |||
2 | 4 / female | 2000 | 0 min – 30 min | nsf |
30 min – 60 min | Reduced spontaneous activity (slight), prone position, shallow breathing | |||
60 min – 180 min | Reduced spontaneous activity (moderate), prone position, ataxia (slight), half eyelid closure, shallow breathing | |||
180 min – 240 min | Reduced spontaneous activity (slight), wasp waist, piloerection (slight) | |||
240 min – Day 2 | Reduced spontaneous activity (slight), hunched posture, piloerection (moderate) | |||
Day 2 – Day 15 | nsf | |||
5 / female | 2000 | 0 min – 30 min | nsf | |
30 min – 120 min | Reduced spontaneous activity (slight) | |||
120 min – 180 min | Reduced spontaneous activity (moderate), prone position, ataxia (slight), wasp waist, half eyelid closure, shallow breathing | |||
180 min | Animal found dead | |||
2 | 6 / female | 2000 | 0 min – 30 min | nsf |
30 min – 60 min | Reduced spontaneous activity (slight) | |||
60 min – 120 min | Reduced spontaneous activity (moderate), ataxia (slight), prone position, half eyelid closure, shallow breathing | |||
120 min – 180 min | Piloerection (slight) | |||
180 min – 240 min | Reduced spontaneous activity (slight), piloerection (slight) | |||
240 min – Day 2 | Reduced spontaneous activity (slight), hunched posture, piloerection (moderate) | |||
Day 2 – Day 15 | nsf |
Day = study day (study Day 1 = day of administration); min = minute(s) post-application; nsf = no specific findings
Based on these results and according to the acute toxic class method regime no further testing was required. Therefore, according to OECD Guideline 423, a sufficient estimation of the acute oral toxicity of the test item is provided
Table 2: Absolute Body Weights (g) and Body Weight Change (%)
Step | Animal No. / Sex | Starting Dose (mg/kg bw) | Body Weight (g) | Body Weight Change in Comparison to Day 1 (%) | ||
Day 1 | Day 2 | Day 3 | ||||
1 | 1 / Female | 2000 | 162 | 184 | 190 | 17 |
2 / Female | 155 | 186 | 194 | 25 | ||
3 / Female | 167 | n.a. | n.a. | - | ||
2 | 4 / Female | 2000 | 166 | 188 | 198 | 19 |
5 / Female | 169 | n.a. | n.a. | - | ||
6 / Female | 176 | 200 | 209 | 19 |
n.a. = not applicable (animals found dead on Day 1)
Table 3: LD50 Cut-Off Value
Starting Dose (mg/kg bw) | Number of Animals | Number of Intercurrent Deaths | LD50 Cut-Off (mg/kg bw) |
2000 | 6 | 2 | 2500 |
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No. 1272/2008
- Conclusions:
- The acute oral toxicity study was conducted according to OECD 423 and in compliance with GLP. Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg bw. The liquid test item was administered undiluted. One animal of the first step was found dead on the day of the treatment (5.5 hours post-dose). The remaining two animals survived until the end of the study. No test item-related signs of toxicity were observed in any of the animals of Step 1. One animal of the second step was found dead on the day of the treatment (3 hours post-dose). The remaining animals of the step survived until the end of the study. Test item-related signs of toxicity were observed in all animals of Step 2. Based on the results, a LD50 cut-off value of 2500 mg/kg bw was derived.
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