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EC number: 812-925-4 | CAS number: 1639345-42-8
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 22 - July 20, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-[fluoro(dimethyl)silyl]butanenitrile
- EC Number:
- 812-925-4
- Cas Number:
- 1639345-42-8
- Molecular formula:
- C6H12FNSi
- IUPAC Name:
- 4-[fluoro(dimethyl)silyl]butanenitrile
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: WISTAR rats Crl: WI(Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Weight at study initiation: males: 237 – 242 g, females: 205 – 232 g
- Housing: The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw
fibre bedding
- Diet: ad libitum, Free access to Altromin 1324 maintenance diet for rats and mice
- Water: 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
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Approximately 24 hours before the test, the fur was removed from the dorsal area of the trunk using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact
skin were used.
No less than 10% of the body surface was cleared for the application.
The test item was held in contact with the skin by a dressing throughout a 24-hour period. This consisted of a semi-occlusive dressing made of a porous gauze and non-irritating tape and was fixed
with an additional dressing in a suitable manner. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- 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). Thereafter, the
animals were observed for clinical signs once daily until the end of the observation period. The animals were weighed on day 1 (prior to the application) and on days 8 and 15.
- Gross necropsy of survivors performed: yes
- Other examinations performed: 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. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: All signs of irritation were reversible within the observation period.
- Mortality:
- No mortality occured.
- Clinical signs:
- No signs of systemic toxicity were observed.
Erythema up to grade 2 was observed in all animals. Crust was observed in 1 of 5 male and 3 of 5 female animals. Desquamation was observed in 5 of 5 male and 3 of 5 female animals. No oedema was observed. All signs of irritation were reversible within the observation period. - Body weight:
- A slight weight loss was recorded for 2 out of 5 female animals (no. 27 and 28) during the first week,
but all of the female animals showed weight gain during the second week. The effects on weight
development might be secondary to the dressing, and toxicological relevance of this finding cannot
clearly be concluded.
The male animals showed weight gain during the first and the second week of the observation. - Gross pathology:
- With the exception of acute injection of blood vessels in the abdominal region, which is due to the
euthanasia injection, no specific gross pathological changes were recorded for any animal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, single dermal application of the test item 3-Cyanopropyldimethylfluorosilane to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity but signs of irritation.
- Executive summary:
The test item was administered topically at a single dose (2000 mg/kg BW) by applying uniformly over an area which was approx. 10% of the total body surface. 5 male animals (WISTAR Crl: WI(Han) rats) as well as 5 female animals (WISTAR Crl: WI(Han) rats) were used.
Test item was held in contact by an semi-occlusive dressing with the skin throughout a 24-hour period. This consisted of a semi-occlusive dressing made of a porous gauze and non-irritating tape and was fixed with an additional dressing in a suitable manner.
At the end of the exposure period the residual test item was removed using aqua ad injectabilia (AlleMan Pharma, lot no. 511535, expiry date: 01/2018).
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). At the end of the observation period the animals were sacrificed and necropsy was carried out to record gross pathological changes.
No signs of systemic toxicity were observed. Erythema up to grade 2 was observed in all animals. Crust was observed in 1 of 5 male and 3 of 5 female animals. Desquamation was observed in 5 of 5 male and 3 of 5 female animals. No oedema was observed. All signs of irritation were reversible within the observation period. Beside acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no special gross pathological changes were found in any animals.
Therefore, according ot OECD Guideline 402, a sufficient estimation of the acute dermal toxicity of the test item is provided.
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