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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 617-769-9 | CAS number: 858956-08-8
- 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
- Study period:
- 16 March - 01 June 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- adopted 12 May 1981
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- traditional method
- Limit test:
- yes
Test material
- Reference substance name:
- 6-amino-5-chloro-2-cyclopropylpyrimidine-4-carboxylic acid
- EC Number:
- 617-769-9
- Cas Number:
- 858956-08-8
- Molecular formula:
- C8H8ClN3O2
- IUPAC Name:
- 6-amino-5-chloro-2-cyclopropylpyrimidine-4-carboxylic acid
1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, North Carolina, USA
- Age at study initiation: approximately 8 weeks (males and females)
- Weight at study initiation: 249 - 270 g (males), 181 - 197 g (females)
- Housing: individually in stainless steel, wire-mesh cages suspended above cage boards
- Diet: PMI® Nutrition International, LLC Certified Rodent LabDiet® 5002, ad libitum
- Water: ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26
- Humidity (%): 30 - 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- 3.5 µm
- Geometric standard deviation (GSD):
- 1.9
- Remark on MMAD/GSD:
- Particle size distribution:
2.2 - 2.5 % of aerosols: less than 1 µm MMAD
37 - 49 % of aerosols: less than 3 µm MMAD
86 - 87 % of aerosols: less than 10 µm MMAD - Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: glass (cylindrical) exposure chamber
- Exposure chamber volume: 36 L
- Method of holding animals in test chamber: Animals were individually restrained in perforated stainless steel cylinders with conical nose pieces. The restrainers were inserted into a polymethylmethacrylate faceplate attached to the exposure chamber so that the nose of each animal extended into the exposure chamber.
- Source and rate of air: house air
- Method of conditioning air: The chamber atmosphere was generated by suspension of the test substance in air with a Fluid Energy Processing model 00 Jet-O-Mizer.
- System of generating particulates/aerosols: The test substance was metered into the jetmill with a K-Tron model T-20 Twin Screw volumetric feeder. Filtered, high-pressure air, metered into the jetmill, carried the resulting atmosphere through a 1-L glass cyclone and into the exposure chamber. Chamber concentrations of test substance were controlled by varying the test substance feed rate to the jetmill.
- Method of particle size determination: Sierra® series 210 cyclone preseparator/cascade impactor and Sierra® series 110 constant flow air sampler
- Treatment of exhaust air: The test atmosphere was exhausted through a high-capacity canister filter prior to discharge into the fume hood.
- Temperature, humidity, airflow range, oxygen concentration: 20-22°C, 45-49%, 20 L/min (34 air changes/h), 21%
TEST ATMOSPHERE
- Brief description of analytical method used: gravimetric analysis. The known volumes of chamber atmosphere were drawn from the sampling port through a 25 mm filter cassette containing a pre-weighed glass fiber (Type A/E) filter. The filters were weighed on a Cahn model C-30 Microbalance®. The atmospheric concentration of the test substance was calculated from the difference between the pre- and post-sampling filter weights divided by the volume of chamber atmosphere sampled. High performance liquid chromatography (HPLC) analysis was used to determine the percentage of active ingredient on the gravimetric filters. HPLC analysis showed that the mean DPX-MAT28 content on the filters was 90% of the collected mean gravimetric mass (8.6 g vs. 9.6 g). The average recovery of DPX-MAT28 active ingredient was 98%.
- Samples taken from breathing zone: yes
VEHICLE
- Composition of vehicle: air
TEST ATMOSPHERE
- Particle size distribution: 2.2 - 2.5 % of aerosols: less than 1 µm MMAD, 37 - 49 % of aerosols: less than 3 µm MMAD, 86 - 87 % of aerosols: less than 10 µm MMAD
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 3.5 μm ± 1.9
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Air samples were collected at 3 separate locations (faceplate) and at the reference port. All samples (faceplate) were within 20% of the overall mean and were homogenously distributed. Difference between faceplate measurements and reference port was <1%.
- Duration of exposure:
- 4 h
- Concentrations:
- 5.4 ± 0.9 mg/L (mean ± standard deviation)
- 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: daily for clinical signs and mortality, body weight at days 0, 1, 2, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight other: gross pathology examination included observation of the nasal passages
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.4 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortalities were observed.
- Clinical signs:
- other:
- Body weight:
- One day following exposure to the test substance, a slight, reduction in mean body weight was observed in males, but not in females. By post-exposure day 2, all rats gained body weight.
- Gross pathology:
- Animals sacrificed at the end of the post-treatment observation period showed no evidence of gross lesions.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- In this acute inhalation toxicity study in rats a LC50 value of > 5.4 mg/L air was determined.
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.