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EC number: 701-417-7 | CAS number: -
- 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
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: LD50 > 2200 mg/kg bw (OECD 401 (1987); GLP compliant)
Acute inhalation toxicity: LC50 (rats; 4 hours) > 5.4 mg/L air (actual concentration) (OECD 403 (1981); GLP compliant)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987-02-24
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - Wistar rats (CHBB: THOM (SPF))
- Age at study initiation: young adults animals
- Weight at study initiation: males: 195 - 200 grams; females: 187 - 192 grams
- Fasting period before study: the animals were given no feed at least 16 hours before administration, but water was available ad libitum.
- Housing: stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG); single housing; no bedding in the cages; sawdust in the waste trays
- Diet (ad libitum, except for fasting period before test item administration): Kliba-Labordiaet 343, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS - the animals were housed in fully air-conditioned rooms.
- Temperature: 20 -24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: Aqua bidest. was chosen since an aqueous formulation corresponds to the physiological medium.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
DOSE CONCENTRATION: 22.000 g/100 mL
DOSAGE PREPARATION: Form of administration was a suspension. - Doses:
- 2200 mg/kg
- No. of animals per sex per dose:
- 5 males / 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- Body weight determination: individual body weights shortly before application (Day 0), weekly thereafter and at the end of the study (before fasting period).
- Signs and symptoms: recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
- General observation and mortality: a check was made twice each workday and once on saturdays, sundays and on public holidays for general observations and for any dead or moribund animals.
- Necropsy of survivors performed: yes; necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before killing with CO2; then necropsy with gross-pathology examination. Necropsy of all animals that died before as early as possible. - Statistics:
- not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 200 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred
- Clinical signs:
- other: No abnormalities were observed at the cageside observations.
- Gross pathology:
- No pathologic findings noted.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (male and female rats) > 2200 mg/kg
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The study fulfils the requirements for acute oral toxicity under REACH (Regulation (EC) 1907/2006).
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991-07-19 to 1991-08-02
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 1981-05-12
- Deviations:
- yes
- Remarks:
- no vehicle control group was used; no acclimatisation period was stated; it was not stated if a dynamic air flow of 12 to 15 air changes per hour was used; no equilibrium period was stated; clinical observations only at least once on workday
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - strain: SPF Wistar/Chbb:THOM
- Source of test animals: Dr. K. Thomae GmbH, D-W7950 Biberach, FRG
- Age at study initiation: approx. 8 - 9 weeks
- Weight at study initiation: males (mean): 279 +/- 6.2 g; females (mean): 191 +/- 6.6 g
- Housing: housed singly in cages type DK III of Becker, without bedding
- Diet (ad libitum during the post exposure period): KLIBA rat/mouse/hamster laboratory diet 24-343-4 10 mm pellets, Klingentalmühle AG, CH-4303 Kaiseraugst, Switzerland
- Water (ad libitum during the post exposure period): drinking water
ENVIRONMENTAL CONDITIONS - the animals were kept in fully air-conditioned rooms
- Temperature: 20 - 24 °C
- Relative humidity: 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- other: Aerosil and clean air
- Mass median aerodynamic diameter (MMAD):
- 2.1 µm
- Geometric standard deviation (GSD):
- 3.6
- Remark on MMAD/GSD:
- The amounts of the material determined in the particle size analysis were not corrected for the additive
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: head-nose inhalation system INA 20 (glass-steel construction, BASF Aktiengesellsschaft, volume V ~55 L): the animals were restrained in tubes and their snouts projected into the inhalation chamber.
- System of generating particulates/aerosols: the aerosol was produced with a dosing -wheel dust generator (Gericke/BASF) and compressed air.
A glass cyclonic separator (BASF) was connected downstream with the generator.
The concentration was adjusted by varying the rotation of the metering disc.
- Source and rate of air/method of conditioning air/treatment of exhaust air: the following air flow (supply air) was set: 1,500 L/h
The supply air was conditioned via a central air-conditioning system. The exposure system was placed in an air-conditioned laboratory.
By means of an exhaust air system the pressure ratios in the inhalation system were adjusted in such a way that the amount of exhaust air was about 10 % lower (excess pressure). This ensured that the mixture of test substance and air was not diluted with laboratory air in the breathing zones of the animals.
- Method of particle size determination: 30 minutes after the beginning of the test at the earliest, one sample was taken per test group for the particle size analysis (equipment: Stack Sampler Mark III (Andersen), vacuum compressed air pump (Millipore), sampling probe (internal diameter 6.9 mm), balance (Sartorius M3P and Mettler AE 240), evaluation unit (IBM-PC with software PGA).
Before the sampling, the impactor was equipped with glass-fiber collecting discs and a backup particle filter. The impactor was connected to the pump and the test apparatus, and one sample (9 L) was taken.
The impactor was taken apart, and the collecting discs and the backup particle filter were weighed.
The contents of the pre-impactor as well as the amounts of the material adsorbed on the walls of the impactor and in the sampling probe (wall losses) were also determined quantitatively.
- Temperature and humidity: the humidity in the inhalation system was not measured due to technical reasons. It is assumed that deviations of humidity values from the guideline requirements (especially low humidity in dust aerosol) did not influence the test results, because of the relative short exposure time.
The temperature in the inhalation system was measured continuously and recorded once.
TEST ATMOSPHERE
- Nominal concentration: the nominal concentration was calculated from the amount of substance consumed and the air flow.
- Brief description of analytical method used: gravimetric determination of the inhalation atmosphere concentration (apparatus: vacuum compressed air pump (Millipore), filtration equipment with probe (internal diameter: 4 mm, (Millipore)), filter (MN 85/90 Bf (d = 4.7 cm), sampling velocity 1.25 m/s, sampling amount 2 L, sampling frequency 1 sample about hourly)(balance: Mettler AT 250)
The preweighed filter was placed into the filtration equipment. By means of a vacuum compressed air pump a volume of the dust aerosol was drawn through the filter.
The dust concentration in mg/L was calculated from the difference between the preweight of the filter and the weight of the filter after sampling, with reference to the sample volume of the inhalation atmosphere. The concentrations were corrected for the amount of the added excipient.
- Samples taken from breathing zone: yes
VEHICLE
- Justification of choice of vehicle: the test substance was mixed with 1% of aerosil in order to achieve a more uniform dust concentration in air.
TEST ATMOSPHERE (if not tabulated)
- MMAD* (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.1 µm (GSD: 3.6) (respirability**: 96 %)
* the amounts of the material determined in the particle size analysis were not corrected for the additive
** respirable dust fraction that might reach the alveolar region, obtained from the results of the particle size analysis - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- please refer "details on inhalation exposure" above
- Duration of exposure:
- 4 h
- Concentrations:
- Actual concentration: 5.4 ± 0.39 mg/L
Nominal concentration: 110 mg/L - No. of animals per sex per dose:
- 5 males / 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the body weight of the animals was checked before the beginning of the test, after 7 days and at the end of the observation period. Clinical findings were recorded for each animal separately several times during exposure and at least once each workday in the observation period. A check for dead animals was made daily.
- Necropsy of survivors performed: yes; at the end of the 14-day observation period the animals were sacrificed with CO2 and were subjected to gross-pathological examination. - Statistics:
- The statistical evaluation of the dose-response relationship was carried out using FORTRAN program AKPROZ. Depending on the data of the dose-response relationship obtained by way of experiment, this program is used to estimate the LC50 or to perform a Probit analysis (see Finney, D.J. (1971): "Probit Analysis", Cambridge University Press). Estimation of the LC50 will produce types LC50 greater, LC50 about, or LC50 smaller. If results are Type LC50 greater or LC50 smaller, an additional binominal test is carried out (Witting, H. (1974): "Mathematical Statistik", B.G. Teubner, Stuttgart, pp. 32 -35.), in order to verify these statements statistically, if necessary.
The calculation of the particle size distribution was carried out in the Department of Toxicology of BASF Aktiengesellschaft on the basis of mathematical methods for evaluating particle measurements (DIN 66141: Darstellung von Korngrößenverteilungen, DIN 66151: Partikelgrößenanalyse (Beuth-Vertrieb GmbH, D-W1000 Berlin 30 and D-W5000 Köln 1). - Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.4 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred at the limit concentration of 5.4 mg/L.
- Clinical signs:
- other: During exposure and in the post-exposure observation period: no abnormalities were detected in the animals of the test group.
- Body weight:
- Body weight gain was not influenced in male animals. The body weight gain of the female rats was slightly retarded over the whole test period.
- Gross pathology:
- No pathological findings were noted in the sacrificed animals.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LC50 (rats; 4 hours) > 5.4 mg/L air (actual concentration)
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the inhalation route.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- The study fulfils the requirements for acute inhalation toxicity under REACH (Regulation (EC) 1907/2006).
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity
One reliable study described in Kirsch (1992; OECD 401 (1987); GLP compliant) is considered to be reliable without restrictions and is used as key study for this endpoint. The LD50 was determined to be greater than 2200 mg/kg bw.
Acute inhalation toxicity
One reliable study described in Gamer (1992; OECD 403 (1981); GLP compliant) is considered to be reliable without restrictions and is used as key study for this endpoint. The LC50 was determined to be greater than 5.4 mg/L air (actual concentration).
Justification for classification or non-classification
Acute oral toxicity
Reference Kirsch (1992) will be used as key study for acute oral toxicity and will be used for classification.
The LD50 was determined to be greater than 2200 mg/kg bw. Thus, according to regulation (EC) 1272/2008 and subsequent amendments the substance is not classified.
Specific target organ toxicant (STOT) - single exposure: oral
The classification criteria according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure, oral are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value, oral for a Category 1 classification (C≤ 300 mg/kg bw) and at the guidance value, oral for a Category 2 classification (2000 mg/kg bw≥C > 300 mg/kg bw). No classification required.
Acute inhalation toxicity
The reference Gamer (1992) is considered as the key study for acute inhalation toxicity of Chromium tin calcium silicon sphene and will be used for classification. Male and female rats were exposed to 5.4 mg/L air (limit test, observation period 14 days) for 4 hours. No mortality occurred. The LC50 is > 5.4 mg/L air.
The classification criteria according to regulation (EC) 1272/2008 as acutely toxic are not met since the ATE is above 5.0 mg/L, hence no classification required.
Specific target organ toxicant (STOT) - single exposure: inhalation
The classification criteria according to regulation (EC) 1272/2008 as specific target organ toxicant (STOT) – single exposure, inhalation (dust/mist/fume) are not met since no reversible or irreversible adverse health effects were observed immediately or delayed after exposure and no effects were observed at the guidance value, inhalation (dust/mist/fume) for a Category 1 classification (C≤ 1 mg/L/4h). Based on the outcome of the limit test on acute inhalation toxicity (0 animals of 10 animals died at a concentration of 5.4 mg/L/4h and no systemic or local effects were observed) it can safely be assumed that no classification for Category 2 (5.0 ≥C > 1.0 mg/L/4h) is required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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