Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 482-400-9 | CAS number: 138776-88-2
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP OECD Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- adopted 07 Sep 2009
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): L4-Ligand
- Physical state: solid, white
- Analytical purity: 97.0 g/100 g
- Lot/batch No.: 0005473663
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor.
- Storage condition of test material: Room temperature; under N2; protect against humidity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories B.V., Kreuzelweg 53, 5961 NM Horst, The Netherlands
- Age at study initiation: male animals approx. 8 weeks, female animals approx. 10 weeks
- Weight at study initiation: mean: males: 232 g, females: 204 g
- Housing: Single housing or up to 5 animals per cage
- Diet: Kliba-Labordiät (Maus / Ratte Haltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: for at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Head-nose inhalation system INA 10 (glass-steel construction, BASF SE, volume V ≈ 34 L): the animals were restrained in glass tubes and their snouts projected into the inhalation system.
- Exposure chamber volume: 34 L
- Source and rate of air: Compressed air is produced by an oil-free compressor (HT 6, Josef Mehrer GmbH & Co KG, Germany). For this purpose, air is filtered by an inlet air strainer and introduced into the compressor. After passed through an second ultra filter (SMF 5/3, 108 mm, Donalson), the compressed air (15 bar) is stored in a storage of 1500 or 5000 L. The compressed air is conducted to the labs via pipes, where the pressure is reduced to 6 bar. In the lab, the compressed air can be taken as required.
- Method of conditioning air: Central air conditioning system provides cold air of about 15°C. This cold air will pass through an activated charcoal filter, be adjusted to room temperature of 20 to 24°C and pass through a second particle filter (H13 (HEPA) Camfil Farr, Germany). The so generated conditioned air is used to generate inhalation atmospheres.
- System of generating particulates/aerosols: The dust was produced inside the dust pre-chamber with the Dosing-wheel dust generator and compressed air and passed via the cyclonic separator into the inhalation system.
- Method of particle size determination: Before sampling, the impactor were assembled with preweighed glass-fiber collecting discs, and equipped with a backup particle filter. The impactor was connected to the vacuum pump and two samples were taken from the breathing zone of the animals sampling occurred 30 minutes (or later) after the beginning of the exposure. The sample volume for each sample was 6 L. After sampling the impactor was taken apart. The collecting discs and the backup particle filter were re-weighed. The amounts of material adsorbed to the walls of the impactor and in the sampling probe (wall losses) were also determined quantitatively.
- Treatment of exhaust air: The flow was adjusted and continuously measured with a flowmeter.
- Temperature, humidity: 20.7 ± 0.4°C, 32.7 ± 3.6 % relative humidity
TEST ATMOSPHERE
- Brief description of analytical method used: Gravimetric measurement of the inhalation atmosphere concentration. Preweighed filters were placed into the filtration equipment. By means of the vacuum pump metered volumes of the dust were drawn through the filter. For each sample 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 atmospheres. Mean and standard deviation were calculated for the concentration from the results of the individual measurements.
Calculation of the concentration:
For each sample the concentration was calculated in mg/L from the analytically determined mass values of the test substance in the samples and the respective volume sampled from the inhalation atmosphere. Mean and standard deviation were calculated for the concentration from the results of the individual measurements.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE (if not tabulated)
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):
Sample 1: MMAD: 2.7 µm and GSD: 2.0
Sample 2: MMAD: 2.9 µm and GSD: 2.0 - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 1,868 mg /L (maximum technically attainable analytical concentration; the limit concentration of 5 mg/L could not be attained because the substance contains large fraction of coarse particles)
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights once during the acclimatization period, shortly before exposure (day 0) and at least on days 1, 3 and 7, and before the sacrifice of the animals at the end of the observation period. Detailed clinical observations were recorded for each animal separately several times during exposure and at least once daily on the pre-exposure day and during the observation period. A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
- Necropsy of survivors performed: yes - Statistics:
- In this study, only one concentration was tested, where no animals died. The result belonged to the type ”LC50 greater than”. Therefore, binomial test was used for statistical evaluation.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1.868 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: maximum technically attainable tested concentration
- Mortality:
- No lethality occurred at the maximum technically attainable tested concentration of 1,868 mg/L during the study period of 14 days.
- Clinical signs:
- other: Clinical signs and findings were observed during (up to 4 hours) and after exposure (> 4 hours) - see table 1. No abnormalities were detected in the animals during the post exposure observation period from study day 3 onwards.
- Body weight:
- The mean body weights of the animals decreased during the first post exposure observation day and increased from study day 3 onward.
- Gross pathology:
- No gross pathological abnormalities were noted during the necropsy in the animals at the termination of the study.
Any other information on results incl. tables
Table 1: Duration of clinical signs:
Test group 1 (1868 mg/L) |
Male animals |
Female animals |
Fur, substance contaminated |
d0 |
d0 |
Respiration, abdominal |
d0 – d2 |
d0 – d2 |
Respiration, labored |
h3 – h4 |
h3 – h4 |
Piloerection |
d0 – d1 |
d0 – d2 |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Although ECHA is providing a lot of online material in your language, part of this page is only in English. More about ECHA’s multilingual practice.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
the-echa-website-uses-cookies
find-out-more-on how-we-use-cookies