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EC number: 242-262-0 | CAS number: 18379-25-4
- 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:
- from 7 May to 28 June 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted largely in accordance with the OECD guideline and with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- doses not as recommended in OECD 423 (2001)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Trichloro(2,4,4-trimethylpentyl)silane
- EC Number:
- 242-262-0
- EC Name:
- Trichloro(2,4,4-trimethylpentyl)silane
- Cas Number:
- 18379-25-4
- Molecular formula:
- C8H17Cl3Si
- IUPAC Name:
- trichloro(2,4,4-trimethylpentyl)silane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, GERMANY
- Age at study initiation: 41 days (males), 48 days (females)
- Weight at study initiation: 179-215 g(males), 175-210 g (females)
- Fasting period before study: 16 h
- Housing: 2-3/Makrolon type III cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 15
- Air changes (per hr): no details
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: 5 cycles (each of 1 day treatment and 14 days observation) overlapping in some cases From: 2002-05-07 To: 2002-06-28
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: neat at 2000 mg/kg bw; in corn oil at 200 and 25 mg/kg bw
- Details on oral exposure:
- VEHICLE
used for 200 and 25 mg/kg bw doses only
- Justification for choice of vehicle: not given
- Lot/batch no. (if required): 81K2204
- Purity: not stated
MAXIMUM DOSE VOLUME APPLIED: 1.87 ml/kg bw in all cases
DOSAGE PREPARATION (if unusual): not given
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: not given
Starting dose 2000 mg/kg bw. The subsequent doses of 200 and 25 mg/kg bw are not as recommended in OECD 423 or the equivalent EC guideline L248: B.1 tris. Also, it is not clear why testing at the mid-dose was repeated in a second sex - Doses:
- 2000, 200 and 25 mg/kg bw
- No. of animals per sex per dose:
- 2000 mg/kg bw 3 males
200 mg/kg bw 3 males followed by 3 females
25 mg/kg bw 3 males followed by 3 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 6 observations on day 1, then daily observations and weekly weighings
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- None.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 25 - < 200 mg/kg bw
- Mortality:
- All males died at 2000 mg/kg bw and 2/3 died at 200 mg/kg bw. No females died at 200 mg/kg bw and no animals died at 25 mg/kg bw. (See also table 1.)
- Clinical signs:
- other: Slight to moderate reduced motiltiy, ataxia and dyspnoea, slightly reduced muscle tone or adopting a lateral or abdominal postition were noted in all animals of the 2000 mg/kg bw group. No clinical signs were noted in any other dose group. (See also table
- Gross pathology:
- No abnormalities were reported.
- Other findings:
- None
Any other information on results incl. tables
Table 1: Number of animals dead or with evident toxicity
Dose |
Mortality (dead/total) |
Time range of deaths |
Number with evident toxicity |
|||
Male |
Female |
Combined |
Male |
Female |
||
2000 |
3/3 |
- |
3/3 |
1h, 1h, 24h* |
3/3 reduced motility and ataxia; 2/3 reduced muscle tone, dyspnoea, prone position |
- |
200 |
2/3 |
0/3 |
2/6 |
1 day, 7 days |
3/3 no clinical signs |
3/3 no clinical signs |
25 |
0/3 |
0/3 |
0/6 |
- |
3/3 no clinical signs |
3/3 no clinical signs |
* sacrificed as moribund
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A reliable study conducted very largely in compliance with the standard guideline and in accordance with GLP, identified an LD50 in the range 25-200 mg/kg bw in male and female rats. There was no evidence of toxicity at the lowest tested dose of 25 mg/kg bw.
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