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EC number: 237-457-2 | CAS number: 13811-50-2
- 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
Endpoint summary
Administrative data
Description of key information
AOT: In the acute oral toxicity study the LD50 (rat) was determined to be 6,987 mg/kg bw.
AIT: In the acute inhalation toxicity study the LC50 (rat) was determined to be > 5.3 mg/L.
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Neither guideline nor GLP compliant study but nevertheless well documented and scientifically acceptable.
- Principles of method if other than guideline:
- according to BASF-internal standard
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Mean weight for male animals about 190 g, for female animals about 177 g.
Diet: The rats received Altromin-R supplied by Altrogge, Lage/Lippe, Germany, and water ad libitum. - Route of administration:
- oral: gavage
- Vehicle:
- other: 30% strength aqueous suspension (weight/vol.) with carboxymethyl cellulose and 2 - 3 drops of Cremophor EL
- Details on oral exposure:
- The test concentration used was 30%.
- Doses:
- 3200, 4000, 5000, 6400, 8000 and 10000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 6 987 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 3200, 4000 and 5000 mg/kg: no deaths after 14 days
6400 mg/kg: 5/10 after 14 days
8000 mg/kg: 8/10 after 14 days
10000 mg/kg: 10/10 after 14 days - Clinical signs:
- other: 6400 and 3200 mg/kg: immediately after administration lateral-abdominal position in some animals, apathy and atonia. Surviving animals normal after 4 days. 8000 and 10000 mg/kg: immediately after administration staggering, abdominal position, dyspnea, int
- Gross pathology:
- Animals that died: general congestion, acute cardiac dilatation, loam-colored liver.
Sacrificed animals: forestomach callously thickened with adhesions to peritoneum. - Interpretation of results:
- not classified
- Remarks:
- Migrated information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 6 987 mg/kg bw
- Quality of whole database:
- Neither guideline nor GLP compliant study but nevertheless well documented and scientifically acceptable.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline compliant but not GLP compliant study but nevertheless well documented and scientifically acceptable.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeding facility : Dr . K . Thomae GmbH, D-W7950 Biberach, Germany
- Age at study initiation: 8 - 9 weeks
- Weight at study initiation: male animals 275 ± 10.1 g, female animals 19.4 ± 6.8 g
- Housing: Groups of five in cages type DK III of Becker, without bedding, with a light/dark rhythm of 12 hours
- Diet: The animals were offered KLIBA rat/mouse laboratory diet, ad libitum
- Water: Drinking water ad libitum, during the post-exposure observation period
ENVIRONMENTAL CONDITIONS
- Temperature: 20-24°C
- Humidity: 30-70%
- Air changes: Fully air-conditioned rooms, range were regulated by means of a central air-conditioning system - Route of administration:
- other: inhalation: dust aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: A dust aerosol was generated by means of a dosing-wheel dust generator (Gericke/BASF). The substance to be tested was ground and mixed with 1.5 weight% aerosil to obtain a more homogeneous distribution of dust in air. Concentration adjustmust was achieved by variable rotation of the dosing wheel.
- Exposure chamber volume: Head-nose inhalation system INA 20 (glass-steel construction, BASF Aktiengesellschaft, volume V = 55 L)
- Method of holding animals in test chamber: The animals were restrained in tubes and their snouts projected into the inhalation chamber.
- Source and rate of air: The following air volume (stream of supply air) was adjusted: Compressed air: 1,500 L/h
- Method of particle size determination: Impactor method ( Stack Sampler Mark III)
- Treatment of exhaust air: 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.
- Temperature, humidity, pressure in air chamber: 19-25°C; Due to appropriate measures, the supply air adjusted itself to the same temperature that was found in the centrally air-conditioned laboratories.
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric determination of the inhalation atmosphere concentration (Sampling amount: 2 L)
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
TEST ATMOSPHERE
- Particle size distribution: Calculated on the basis of mathematical methods of evaluation for particle measurements (DIN 66 141, Representation of particle size distribution, DIN 66 161 : Particle size analysis)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 50% = 4.9 µm; GSD = 2.5
CLASS METHOD
- Rationale for the selection of the starting concentration: Based on guideline - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Gravimetric determination of the inhalation atmosphere concentration
- Duration of exposure:
- 4 h
- Concentrations:
- 5.3 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- 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 several times during exposure and at least once on 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 C02 and were subjected to gross-pathological examination
- Other examinations performed: clinical signs, body weight - Statistics:
- The statistical evaluation of the concentration-response relationship was based on the binominal test.
The particle size distribution was calculated on the basis of mathematical methods of evaluation for particle measurements. - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.3 mg/L air
- Based on:
- test mat.
- 95% CL:
- > 99.9
- Exp. duration:
- 4 h
- Mortality:
- none
- Clinical signs:
- other: During exposure: Accelerated breathing; reddish nasal discharge After exposure: Accelerated breathing; general state of health slightly deteriorated; piloerection; fur around snout with reddish smear (blood test positive). The animals of the concentration
- Body weight:
- Compared to the historical control, the body weight change of the male and female animals of the test group was slightly retarded during the first week of observation, but became normal during the second week of observation.
- Gross pathology:
- Sacrificed animals (male and female animals): Nothing abnormal found in the organs.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 5.3 mg/m³ air
- Quality of whole database:
- Guideline compliant but not GLP compliant study but nevertheless well documented and scientifically acceptable.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Key study
Acute oral toxicity
BASF SE, study no.: XXIII/95, 1974
The acute oral toxicity of the test substance was determined in Sprague-Dawley rats. For this purpose, the product was administered once by gavage as a 30% aqueous suspension (weight/volume) with carboxymethyl cellulose and 2 - 3 drops of Cremophor EL at doses of 3,200 ; 4,000 ; 5,000 ; 6,400 ; 8,000 ; and 10,000 mg/kg .
The mean lethal dose (LD50) calculated according to FINNEY was 6,987 (6,327 - 7,716) mg/kg .
Key study
Acute inhalation study
BASF SE, study no.: 13I0403/887052, 1988
In an OECD 403 guideline compliant but not GLP compliant study the test substance was examined in rats at a concentration of 5.3 mg/L. 5 animals per sex were exposed to the test substance over a period time of 4 hours. No mortality was observed; therefore the LC50 was determined to be > 5.3 mg/L.
Justification for selection of acute toxicity – oral endpoint
Neither guideline nor GLP compliant study but nevertheless well documented and scientifically acceptable.
Justification for selection of acute toxicity – inhalation endpoint
Guideline compliant but not GLP compliant study but nevertheless well documented and scientifically acceptable.
Justification for classification or non-classification
Acute oral toxicity
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for acute oral toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.
Acute inhalation toxicity
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for acute inhalation toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.
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