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EC number: 609-386-0 | CAS number: 37288-11-2
- 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
- Study period:
- 3 December 1999 - 17 December 1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 12 May 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Version / remarks:
- 31 July 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- dd. 23 December 1999
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- liquid
- Details on test material:
- Physical appearance: brown liquid
Storage conditions:in a freezer in the dark or, after thawing, in a refrigerator 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: Charles River Deutschland, Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: not indicated
- Age at study initiation: 5-6 weeks
- Mean weight at study initiation: 324 g (males), 192 g (females)
- Fasting period before study:
- Housing: grouphousing (based on sex) in stainless steel cages fitted with wire-mesh floor and front
- Diet: Rat & Mouse No. 3 Breeding Diet RM3 (SDS Special Diets Services, Witham, England.
- Water: tap water suited for human consumption
- Acclimation period: 42-44 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.0-21.5
- Humidity (%): 40-62
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 3 December 1999 - 17 December 1999
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: the test material was diluted with water to diminish clogging of the nebulizer
- Mass median aerodynamic diameter (MMAD):
- 3.2 µm
- Geometric standard deviation (GSD):
- 1.3
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Nose-only inhalation chamber consisting of a cylindrical aluminium column, surrounded by a transparent cylinder.
- Exposure chamber volume: 50 L
- Method of holding animals in test chamber: Animals were secured in plastic animal holders (Batelle)
- Source and rate of air: 24.4 L/min
- System of generating particulates/aerosols: The test item was nebulized into smal droplets by using a compressed air driven nebulizer (Schlick, Coburg, Germany, type 970/S) at a constant pressure of 1.0 bar. The test item (130 g) was diluted with demineralized water (65 g) to diminish clogging of the nebulizer.
- Method of particle size determination: By gravimetric analysis (once per hour)
- Temperature, humidity, oxygen content, pressure in air chamber: 20.8 ± 0.21°C, 71 ± 2%, 21.1%, respectively
- Other: By securing a positive pressure in the central column and a slightly negative pressure in the outer cylinder, dilution of test atmosphere at the nose of the animals is prevented.
TEST ATMOSPHERE
- Samples taken from breathing zone: No, samples were taken by passing 10 L test atmosphere samples at 5 L/min through glass fibre filters.
- Brief description of analytical method used: An 11-stage cascade impactor (Institue's design) with the largest cut-off size of 4.2 µm was used.
- Particle size distribution and MMAD: see table 1
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: the starting concentration of 5 g/m^3 was selected based on international guidelines. Since no mortality occurred, no further groups were exposed. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5 g/m^3
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Visual observations for abnormal behaviour, clinical signs and mortality were performed just before exposure, during the treatment, at least once during the observation period and shortly after exposure. Bodyweights were recorded prior to exposure (day 0), on day 7 and 14.
- Necropsy of survivors performed: yes - Statistics:
- No statistics performed
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 150 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: A slightly decreased breathing rate was observed in two females at the second observation time, in all females at the third observation time and in all animals (male and female) at the last observation time. In addition, slight laboured breathing was obse
- Body weight:
- Mean overall bodyweight gain during the 14-day observation period was within the normal range expected for animals of this strain and age.
- Gross pathology:
- No abnormal macroscopic findings were found in any of the animals.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of an acute inhalation study in male and female Wistar rats, performed according to OECD guideline 403 and GLP principles, the 4-hour LC50 of NPH 54 was >5.15 g/m^3.
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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