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EC number: 242-056-0 | CAS number: 18171-19-2
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was carried out in accordance with an appropriate OECD test guideline and in compliance with GLP, and is therefore considered to be reliability 1. Read-across of the result is considered to be reliability 2. Further information on read-across is given in the endpoint summary.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 3-chloropropyltrimethoxysilane
- EC Number:
- 219-787-9
- EC Name:
- 3-chloropropyltrimethoxysilane
- Cas Number:
- 2530-87-2
- Molecular formula:
- C6H15ClO3Si
- IUPAC Name:
- 3-Chloropropyl(trimethoxy)silane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats were obtained from Charles River Deutschland GmbH
Animals were a minimum of 8 weeks of age at delivery. Males were 309-377 grams and females were 204-248 grams. Animals were acclimated for 7 days prior to treatment, under test conditions with an evaluation of the health status. Animals rooms were air conditioned with 10-15 air changes per hour; the environment was monitored continously with recordings of temperature and relative humidity, 12 hours artificial fluorescent light/12 hours dark with background music played at a centrally defined low volume for at least 8 hours during the light period. Animals were housed in Makrolon (R) cages with wire mesh tops and standard granulated softwood bedding. Pelleted standard rat/mouse maintenance diet was available ad libitum. Tap water from Fullinsdorf in bottles was available ad libitum.
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- The vapor generation system consisted of a round bottomed flask that was placed in a heating device set at 30 °C. Compressed air was
supplied into the glass flasks and allowed the liquid test item to equilibrate with the temperature of the walls of the container. The vapor
produced passed through a pipe and was then mixed and diluted with filtered air and conveyed to the inlet of the whole-body exposure
chamber. After set-up of the definitive generation system the chamber concentration and stability of CPTMO over the duration of 6 hours
was determined on two occasions prior to the start of the animal exposures. - Details on mating procedure:
- During the pairing period, rats were housed overnight with one male and one female in Makrolon pairing cages. The female was placed with the same male until mating occurred or two weeks elapsed.
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- The nominal atmosphere concentration was determined once daily by weighing the test item container before and after each exposure.
The weight of the test item used was divided by the total air flow volume to give the nominal concentration. The test atmosphere
concentration in each chamber was determined daily, 5 times per hour per chamber during each hour of exposure. - Duration of treatment / exposure:
- Exposure period: 28 days Premating exposure period (males): 14 days Premating exposure period (females): 14 days Duration of test: until the individual day 19 post coitum
(3-Chloropropyl)trimethoxysilane was administered for 6 hours daily by whole-body vapour inhalation to male rats for 28 days and to female rats throughout the 14-day pre-pairing, pairing and gestation period until the individual day 19 post coitum. - Frequency of treatment:
- daily
- Details on study schedule:
- Premating exposure period (males): 14 days
Premating exposure period (females): 14 days
Duration of test: until the individual day 19 post coitum
(3-Chloropropyl)trimethoxysilane was administered for 6 hours daily by whole-body vapour inhalation to male rats for 28 days and to female rats throughout the 14-day pre-pairing, pairing and gestation period until the individual day 19 post coitum.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 5, 25 and 100 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- The animals were exposed to the following mean test item concentrations:
Group 1: 0 ppm (air control)
Group 2: 5 ppm
Group 3: 25 ppm
Group 4: 100 ppm
Control animals were exposed to air only under the same conditions as animals exposed to the test item.
P generation males were sacrificed after they had been treated for 28 days, P generation females and pups were sacrificed on day 4 post partum.
Examinations
- Parental animals: Observations and examinations:
- Animals were observed twice daily for mortalities and clinical signs. Detailed clinical observations were performed once per week. A Functional Observational battery (modified Irwin screen test) was performed once during the test (males: shortly before sacrifice; females: on day 3 post-partum). Body weights and food consumption was recorded.
- Litter observations:
- The litters were examined for litter size, live birth, stillbirth and any gross anomalies. The sex ratio of the pups were recorded. Pups were weighed individually on day 0, 1 and 4 post partum. The pups were observed daily for survival and behavioral abnormalities in nesting and nursing. Dead pups and pups killed on day 4 post partum were examined macroscopically.
- Postmortem examinations (parental animals):
- Parental generation males were sacrificed after they had been treated for 28 days, parental generation females were sacrificed on day 4 post partum.
A complete gross necropsy was performed on all adult animals.
ORGAN WEIGHTS From all adult males and females the following organs were taken, trimmed and weighed: liver, heart, adrenals*, overies*,
thymus, uterus, kidneys*, testes*, spleen, epididymides*, seminal vesicles, with coagulating glands and their fluids(as one unit), lungs, prostate,
brain * = paired weights
TISSUE PRESERVATION The following tissues were collected from all adult males and females and preserved in neutral phosphate buffered
4% formaldehyde solution (except for testes and epididymides, which were fixed in Bouin's fixative): gross lesions, uterus, heart, brain,
thymus, spinal cord, thyroid, small and large intestines (incl. Peyers Patches), trachea and lungs (preserved by inflation with fixative and then
immersion), stomach, urinary bladder, liver, lymph nodes (mediastinal and mesenteric), kidneys, sciatic nerve, adrenals, bone marrow, spleen,
testes, ovaries, epididymides, uterus, prostate, seminal vesicles with coagulation glands
Full histopathology was carried out on the preserved organs and tissues of the control and high dose group animals.Examinations were extended to lower dose group animals if treatment related changes were seen in the high dose group.
For perganant females, the number of corora lutea and the number of impantation sites were recorded. Mated females that did not deliver were sacrificed on gestation day 24-27. Histological exam of ovaries and uterus was carried out onany females that did not give birth. Microscopic exam of the reproductive organs of all infertile males was made if necessary. - Postmortem examinations (offspring):
- Pups were sacrificed on day 4 post partum.The litters were examined for litter size, live birth, stillbirth and any gross anomalies.
- Statistics:
- Statistical Methods: Mean and standard deviation of data were calculated. Univariate one-way analysis of variance was used to assess the
significance of intergroup differences. If the variables were assumed to follow a normal distribution, the Dunnett t-test, based on a pooled variance estimate, was used for intergroup comparisons. The Steel test (rank test) was applied when the data could not be assumed to follow a normal distribution. Fisher's Exact test for 2x2 tables was applied if the variables could be dichotomized without loss of information. - Reproductive indices:
- Fertlity and mating performance
Duration of gestation
Implantation rate and Post-implantation loss
Litter size at first litter check
Postnatal loss day 0 - 4 post partum - Offspring viability indices:
- Abnormal findings at first litter check and during lacatation to weaning
Sex ratios
Pup weights to day 4 post partum
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Details on results (P0)
no treatment-related effects on precoital time, fertility indices, mean duration of gestation, number of implantations, post-implantation
loss through to scheduled sacrifice on day 4 post partum. The mean number of corpora lutea per dam (determined at necropsy) was
similar in all groups and gave no indication of a test item-related effect. There were no findings, which distinguished test item-treated
animals from controls. In particular, no treatment-related histopathological findings were observed in the reproductive organs of either
sex from the parental generation. The assessment of the integrity of the spermatogenetic cycle did not provide any evidence of impaired
spermatogenesis.
Effect levels (P0)
- Dose descriptor:
- NOAEC
- Effect level:
- >= 100 ppm (nominal)
- Based on:
- test mat.
- Sex:
- male/female
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
day 4 post partum.
No abnormal findings were noted for pups at first litter check or during the first 4 days post partum. Sex ratios at first litter check and on day 4 post partum were unaffected by treatment with the test item. Mean pup weights on day 0 and day 1 post partum were unaffected by treatment with the test item. Mean pup weight development during the first 4 days post partum lactation was unaffected by treatment with the test item.
Effect levels (F1)
- Dose descriptor:
- NOAEC
- Generation:
- F1
- Effect level:
- >= 100 ppm (nominal)
- Based on:
- test mat.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Exposure to (3-Chloropropyl)trimethoxysilane up to and including the high concentration of 100 ppm did not result in any signs of
general or reproductive toxicity of the test item.
Based on these results the NOEC (no observed effect concentration) was established as >=100 ppm.
Applicant's summary and conclusion
- Conclusions:
- Exposure to (3-Chloropropyl)trimethoxysilane up to and including the high concentration of 100 ppm did not result in any signs of
general or reproductive toxicity of the test item. Based on these results the NOEC (no observed effect concentration) was established as >=100 ppm.
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