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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 939-039-1 | 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 May 2015 ---- 23 November 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- Identification methods in the protocol were tail mark and microchip; but only microchip method was used and actual animal identity was confirmed with a microchip reader. As all animals were uniquely identified, the integrity of the study was not affected.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- Name of test material (as cited in study report): 20231250
- Physical state: powder
- Storage condition of test material: room temperature (ca. 20°C) in the dark
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 (UK) Ltd.
- Age at study initiation: 9 to 10 weeks
- Weight at study initiation: 256 to 286 g (males) and 166 to 173 g (females)
- Fasting period before study:no
- Housing: The animals were housed three of one sex per cage
- Diet: Ad libitum, standard rodent diet (Harlan teklad 2014C Diet). This diet contained no added antibiotic or other chemotherapeutic or prophylactic agent.
- Water: Ad libitum, potable water taken from the public supply.
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 23°C
- Humidity: 40 to 70%
- Air changes (per hr):Each animal room was supplied with filtered fresh air, which was passed to atmosphere and not re-circulated.
- Photoperiod (hrs dark / hrs light): 12 h continuous light and 12 h continuous dark/24 h.
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 2.9 µm
- Geometric standard deviation (GSD):
- 2.33
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: flow through nose only chamber. This system was an aluminium alloy construction comprising a base unit, a single animal exposure section with 20 ports and a top section incorporating a central aerosol inlet.
- Method of holding animals in test chamber: Rats were held in polycarbonate tubes with their snouts protruding from the end of the tubes into the exposure chamber.
- Source and rate of air: From in-house compressed air system(breathing quality), Generator flow: 19 L/minute
- System of generating particulates/aerosols: Wright dust Feed(WDF) designed to produce and maintain test atmospheres containing dust by scraped from the surface of a compressed powder in a stream of dry air. The concentration of dust in the air was altered by changing the gear ratio of the mechanism and therefore the speed of rotation of the compressed powder towards the scraper blade.The WDF mechanism was attached directly to the top of the exposure chamber.
- Temperature, humidity, pressure in air chamber:
Chamber air temperature was measured using an electronic thermometer probe placed in the breathing zone of the animals via an unused exposure port. The mean chamber temperature value was 22.6°C.
- Humidity: Chamber relative humidity was measured using an electronic hygrometer probe inserted into the breathing zone of the animals via an unused exposure port. The mean chamber relative humidity was 18.7%
Pressure in air chamber was not reported.
- Air flow rate: Airflow were 19 L/minute.
- Method of particle size determination: Particle size analysis of generated atmospheres was performed using a 8-stage cascade impactor (Marple 298). A measured volume of air was drawn at a rate of 2 litres/minute from an unused exposure port on the exposure chamber through the cascade impactor and measured using a wet-type gas meter in line with a pump. Two samples were collected during the exposure. The collection substrates and the backup filter were weighed before and after sampling and the weight of test item, collected at each stage, was calculated by this difference. The total amount collected for each stage was used to determine the cumulative amount below each cut-off point size. In this way, the proportion (%) of aerosol less than < 0.52, 0.93, 1.55, 3.5, 6.0 , 9.8, 14.8 and 21.3 µm (aerodynamic diameter) was calculated. From this data, the Mass Median Aerodynamic Diameter (MMAD), and Geometric Standard Deviation (GSD) were calculated. The mean MMAD was 2.9 µm and the geometric standard deviation (GSD) was 2.33.
- Treatment of exhaust air: Extract airflow was drawn by in-house vacuum system at a flow rate of 20 L/minute. the airflow was filtered locally.
TEST ATMOSPHERE
- Brief description of analytical method used: A measured volume of air was drawn at a rate of 2 litres/minute from an unused exposure port on the exposure chamber through a glass microfibre filter, mounted in an open face filter holder and measured using a wet-type gas meter in line with a pump. Eight samples were collected during the exposure. The filters were weighed before and after sampling.. The difference in the pre- and post-sampling weights, divided by the volume of atmosphere sampled, was equal to the actual achieved test atmosphere concentration. The mean achieved test atmosphere concentration was 5.25 +/- 0.541 mg/L
- Samples taken from breathing zone: yes, samples were collected from a vacant animal exposure port.
VEHICLE (if applicable)
- none - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- Target concentration: 5.0 mg/L
Mean achieved atmosphere concentration: 5.25 mg/L ; Standard deviation: 0.541 - No. of animals per sex per dose:
- 3/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
OBSERVATIONS:
- Morbidity/Mortality: Animals were checked hourly during exposure, immediately following exposure and then at 1 h and 2 hrs post-exposure. During the 14-day observation period, the animals were observed twice daily for morbidity and/or mortality.
- Clinical Signs: All animals were observed for clinical signs at hourly intervals during exposure, as soon as practically possible following removal from restraint at the end of exposure, 1 h and 2-hrs after exposure and subsequently twice daily for 14 days.
- Bodyweight: Individual bodyweights were recorded prior to treatment, on the day of exposure (Day 1) prior to dosing and on Days 2, 4, 8 and 15 (or at death).
- Necropsy: All animals were subject to a gross necropsy which consisted of opening the cranial, thoracic and abdominal cavities.any macroscopic abnormalities in appareance of the organs were recorded. - Statistics:
- None
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.25 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- There were 2 decedents during the study: Females 301 and 303 were sent to necropsy for welfare reasons approximately 3 or 1.75 hours respectively after completion of exposure. Clinical signs apparent for these animals immediately after exposure included unsteady gait, decreased activity, gasping, irregular or laboured breathing, wet rales, partially closed eyes and wet fur. These signs were generally present at the time of despatch to necropsy with piloerection, whole body pallor and hunched posture. Macroscopic examination revealed dark areas between 1 to 5 mm in diameter on all lung lobes.
- Clinical signs:
- other: Deep and/or laboured breathing was apparent in one female at 3 hours after start of exposure and in all animals at 3.5 hours after start of exposure. Immediately following exposure, clinical signs for the majority of animals included laboured deep breath
- Body weight:
- Body weight loss was observed in all males and the single remaining female on the day following the 4 hour exposure. The removal of food and water during exposure is considered to have contributed to the observed body weight loss and is therefore not solely attributed to treatment with the test substance.
All animals had recovered from the initial body weight loss by the next weighing occasion, and the group mean body weights from both sexes increased from Day 4 of the observation period onwards. - Gross pathology:
- The macroscopic examination of the two decedents revealed dark areas between 1 to 5 mm on all lung lobes. There were no macroscopic findings in the remaining animals.
Any other information on results incl. tables
Table 7.2.2/1: Signs associated with dosing -Individual observations on Day 1
Group /sex |
Animal number |
Day of death |
Category |
Observation |
Day(s) observed |
|||||
1 M |
|
|
|
|
3hours after start of dosing |
3.5hours after start of dosing |
On return to home cage |
1hour post dose |
2hours Post dose |
At the end of the working day |
0201 |
15 |
Abnormal gait |
Unsteady |
|
|
1 |
1 |
1 |
1 |
|
Behavior |
Decreased activity
|
|
|
1 |
1 |
1 |
1 |
|||
Salivation excessive |
|
|
1 |
|
|
|
||||
Breathing |
Labored, animal appears to be breathing deeply
|
|
1 |
1 |
1 |
1 |
1 |
|||
Rales,wet |
|
|
|
1 |
1 |
1 |
||||
0202 |
15 |
Abnormal gait |
Unsteady |
|
|
1 |
1 |
1 |
1 |
|
Behavior |
Decreased activity
|
|
|
1 |
1 |
1 |
1 |
|||
Breathing |
Labored, animal appears to be breathing deeply
|
|
1 |
1 |
1 |
1 |
1 |
|||
Rales,wet |
|
|
|
1 |
1 |
1 |
||||
0203 |
15 |
Abnormal gait |
Unsteady |
|
|
1 |
1 |
1 |
1 |
|
Behavior |
Decreased activity
|
|
|
1 |
1 |
1 |
1 |
|||
Salivation excessive |
|
|
1 |
|
|
|
||||
Breathing |
Gasping |
|
|
1 |
1 |
1 |
|
|||
Labored, animal appears to be breathing deeply
|
|
1 |
|
1 |
1 |
1 |
||||
Eyelids |
Partially closed, bilateral |
|
|
1 |
1 |
1 |
1 |
|||
|
|
|
|
|
|
|
|
Only animals with observations are presented
Group /sex |
Animal number |
Day of death |
Category |
Observation |
Day(s) observed |
|||||
1F |
|
|
|
|
3hours after start of dosing |
3.5hours after start of dosing |
On return to home cage |
1hour post dose |
2hours Post dose |
At the end of the working day |
0301 WE |
1 |
Abnormal gait |
Unsteady |
|
|
1 |
1 |
1 |
|
|
Behavior |
Decreased activity
|
|
|
1 |
1 |
1 |
|
|||
Salivation excessive |
|
|
1 |
|
|
|
||||
Breathing |
Gasping |
|
|
1 |
1 |
1 |
|
|||
Irregular |
|
1 |
|
|
|
|
||||
Labored |
1 |
1 |
1 |
1 |
1 |
|
||||
Rales,Wet |
|
|
|
1 |
1 |
|
||||
Coat |
Piloerection |
|
|
|
|
1 |
|
|||
Wet fur,Marked |
1 |
1 |
1 |
1 |
|
|
||||
Posture |
Hunched |
|
|
|
|
1 |
|
|||
0302 |
15 |
Abnormal gait |
Unsteady |
|
|
1 |
1 |
1 |
1 |
|
Behavior |
Salivation excessive |
|
|
1 |
|
|
|
|||
Breathing |
Labored, animal appears to be breathing deeply
|
|
1 |
1 |
1 |
1 |
1 |
|||
Rales, Wet |
|
|
|
1 |
1 |
1 |
||||
Coat |
Piloerection |
|
|
|
|
1 |
1 |
|||
Wet fur,Marked |
1 |
1 |
1 |
1 |
|
|
||||
Eyelids |
Partially closed, bilateral |
|
|
|
|
1 |
1 |
|||
Posture |
Hunched |
|
|
|
|
1 |
1 |
|||
0303 WE |
1 |
Abnormal gait |
Unsteady |
|
|
1 |
1 |
|
|
|
Behavior |
Decreased activity
|
|
|
1 |
1 |
|
|
|||
Breathing |
Gasping |
|
|
1 |
1 |
|
|
|||
Irregular |
|
|
1 |
1 |
|
|
||||
Labored, animal appears to be breathing deeply
|
|
1 |
|
|
|
|
||||
Rales, Wet |
|
|
|
1 |
|
|
||||
Coat |
Wet fur,Marked |
|
|
1 |
1 |
|
|
|||
Eyelids |
Partially closed, bilateral |
|
|
1 |
1 |
|
|
WE: euthanazied for welfare reasons
Only animals with observations are presented
Table 7.2.2/2: Signs associated with dosing -Individual observations on Days 2 to 15
Group /sex |
Animal number |
Day of death |
Category |
Observation |
Day(s) observed |
||||
|
|
|
|
|
Initial check |
Additionnal observation |
Additionnal observation |
Additionnal observation |
At the end of the working day |
1F |
0302 |
15 |
Breathing |
Rales, Wet |
2 |
2 |
|
|
|
|
|
|
Coat |
Piloerection |
2 |
2 |
2 |
2 |
2 |
|
|
|
Posture |
Hunched |
2-3 |
2 |
2 |
2 |
2-3 |
Only animals with observations are presented
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The LC50 of the test substance was in excess of 5.25 mg/L for male and female rats.
The substance is not classified according to Regulation (EC) No. 1272/2008 and its subsequent amendments on classification, labeling and packaging (CLP) of substances and mixtures.
According to the Globally Harmonized Classification System (GHS; UNITED NATIONS), the substance is classified as Category 5. - Executive summary:
The substance was tested for acute inhalation toxicity according to the OECD 436 guideline and in compliance with Good Laboratory Practice.
A group of three male and three female Wistar rats was exposed, nose-only, to an atmosphere of the test item using a flow-through exposure system. The animals were exposed for four hours to a target concentration of 5 mg/L followed by a fourteen day observation period. Each animal was observed for mortality and clinical signs at hourly intervals during exposure, then one hour and two hours after exposure and at least twice a day during the 14 -day observation period. Bodyweights were recorded before treatment then on the day of exposure (day 1) and on days 2, 4,8 and 15. All surviving animals were necropsied at the end of the observation period.
The mean achieved atmosphere concentration was 5.25 mg/L and the mean mass median aerodynamic diameter was 2.9 µm.
There were two decedents during the study: 2 Female were sent to necropsy for welfare reasons approximately 3 or 1.75 hours respectively after completion of exposure on Day 1. Clinical signs apparent for these animals immediately after exposure included unsteady gait, decreased activity, gasping, irregular or laboured breathing, wet rales, partially closed eyes and wet fur. These signs were generally present at the time of despatch to necropsy with piloerection, whole body pallor and hunched posture also evident at this point. Macroscopic examination revealed dark areas between 1 to 5 mm in diameter on all lung lobes. Deep and/or laboured breathing was apparent in one female at 3 hours after start of exposure and in all animals at 3.5 hours after start of exposure.
Clinical signs for the majority of animals immediately following exposure included laboured deep breathing or gasping, unsteady gait and decreased activity; partially closed eyes, excessive salivation and wet fur. The majority of these signs were still evident at the 1 and 2 hour post-exposure and end of day checks with the exception of excessive salivation, wet fur or gasping that were not present at the 1 hour post-exposure, 2 hour post-exposure or end of day time points respectively. In addition, for a proportion of animals, wet rales was apparent from 1 hour post-exposure with hunched posture and piloerection evident from 2 hours post-exposure; these signs persisted for the surviving female up to Day 2 (piloerection and wet rales) or Day 3 (hunched posture). All males were considered normal from Day 2 and the surviving female from Day 4.
There were no adverse bodyweight effects observed. The macroscopic examination revealed dark areas between 1 to 5 mm in diameter on all lung lobes of the 2 decedents. There were no macroscopic findings on the remaining animals.
The 4 -hour inhalation LC50 was found to be greater than 5.25 mg/L (ie 5250 mg/m3).
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.
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.
This website uses cookies to ensure you get the best experience on our websites.
Find out more on how we use cookies.