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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 206-462-1 | CAS number: 345-78-8
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP, OECD guideline study, available as unpublished report. Minor restrictions in design and/or reporting but otherwise adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Pseudoephedrine hydrochloride
- EC Number:
- 206-462-1
- EC Name:
- Pseudoephedrine hydrochloride
- Cas Number:
- 345-78-8
- Molecular formula:
- C10H15NO.ClH
- IUPAC Name:
- 2-(methylamino)-1-phenylpropan-1-ol hydrochloride
- Details on test material:
- - Name of the test substance used in the study report: (+)-Pseudoephedrine hydrochloride
- Appearance: white chrystals
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, D-7950 Biberach, Germany
- Weight at study initiation: 281 ± 7.8 g (males); 193 ± 5.62 g (females)
- Age at study initiation: ca. 8 - 9 weeks
- Housing: 5 animals per cage in stainless steel cages (Type D III)
- Diet: Kliba-Labordiat Ratte/Maus A 343 10 mm pellet, Fa. Klingentalmuhle AG, CH-4303 Kaiseraugst, Switzerland, ad libitum
- Water: ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod: (12 hrs dark / 12 hrs light)
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 20 (Glas-Steel-Construction, BASF AG) (animals were sitting in a tube with the snout rising into the inhalation chamber.
- Exposure chamber volume: 55 L
- Source and rate of air: Compressed air (1500 L/h), air for dilution (1500 L/h)
- System of generating particulates/aerosols: A Dust-Air-mixture was generated with a rotating brush generator (TH - Karlsruhe/BASF). Adjustment of concentration was performed by means of variable rotation of the rotating brush generator and by variable piston setting.
- Method of particle size determination: At least 30 minutes after beginning of the study, an air sample of 30 L was taken and the particles sizes were analysed by means of a Stack Sampler Mark III (Andersen ) and gravimetrical determination.
- Temperature, humidity, pressure in air chamber: 19-25°C, excess pressure (outlet air was 10% less than inlet air)
TEST ATMOSPHERE
- Brief description of analytical method used: air sample was taken from the breathing zone with a vacuum pump and filtered (MN 85/90 8f; d = 4,7 cm). A sample of one liter air (1.25 m/s) was taken every hour. The amount of dust was determined by gravimetrical analysis of the filter weight before and after sample taking.
- Samples taken from breathing zone: yes
TEST ATMOSPHERE
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 5.7 µm/2.6
- Rationale for the selection of the starting concentration: The concentration was chosen based on the results of the acute oral toxicity study. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 2 mg/L
- No. of animals per sex per dose:
- 5
- Control animals:
- other: historical controls
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administration, at least once each workday. Check for moribund and dead animals at least once daily. Weighing was performed before study begin and after 7 and 14 days.
- Necropsy of survivors performed: yes - Statistics:
- Calculation of particle size distribution was performed on the basis of mathematical methods for particle measurements (Silverman, L.: Particle Size Analysis in Industrial Hygiene, 1971, S. 235 - 259) in the Department of Toxicology (BASF AG).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred
- Clinical signs:
- other: During exposure: Nose discharge (reddish), salivation and, accelerated respiration. After exposure: Fur smeared (bloody, near head), accelerated/irregular respiration, respiratory sounds, piloerection. All symptoms were reversible within 5 (males) and 8 (
- Body weight:
- No difference between the weight gain of the test group and the historical control in the males. The weight gain of the females was delayed during the first week, but adjusted to a normal weigt gain during the second week post exposure (details see table 1 "Any other information on results incl. tables")
- Gross pathology:
- No abnormalities observed.
Any other information on results incl. tables
Table 1: Body weights of male and female animals before and after exposure to the test substance.
|
Test group (2 mg/L) |
Historical control |
Males |
|
|
Beginning of the test |
281 |
248 |
7 days |
305 |
285 |
14 days |
341 |
317 |
|
|
|
Females |
|
|
Beginning of the test |
193 |
177 |
7 days |
198 |
196 |
14 days |
212 |
210 |
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the performed acute toxicity test the LC50 for inhalation was determined to be >2 mg/L air.
- Executive summary:
In a OECD Guideline 403 acute inhalation toxicity study, five Wistar rats per sex were exposed to 2 mg/L air dust aerosol of the test substance. After an 14 day observation period surviving animals were necropsied. During exposure nose discharge (reddish), salivation and, accelerated respiration were observed. After exposure smeared fur (bloody, near head), accelerated/irregular respiration, respiratory sounds and, piloerection was observed. All symptoms were reversible within 5 (males) and 8 (females) days. The LC50 was determined to be >2 mg/L air.
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.