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EC number: 823-376-5 | CAS number: 27192-21-8
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov. 2018 - Feb. 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Qualifier:
- according to guideline
- Guideline:
- other: Method B1 bis of Council Regulation (EC) No. 440/2008
- GLP compliance:
- yes
- Remarks:
- given by compliance statement and signature
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- 5-bromo-4-chloro-6-cyclopropylpyrimidine
- EC Number:
- 823-376-5
- Cas Number:
- 27192-21-8
- Molecular formula:
- C7H6BrClN2
- IUPAC Name:
- 5-bromo-4-chloro-6-cyclopropylpyrimidine
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:WI(Han)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test animals
Female (nulliparous, non-pregnant) Crl:WI(Han) strain rats were obtained from Charles
River (UK) Ltd., Margate.
Environmental conditions
The animals were kept in the following conditions except for short periods of time where experimental procedures dictated otherwise.
The animals were housed in groups of up to four in cages that conformed to the 'Code of Practice for the Housing and Care of Animals Bred, Supplied or Used for Scientific Purposes’ (Home Office, London, 2014).
Mains water was provided ad libitum via water bottles. The water was periodically analysed for specific contaminants.
Throughout the study the animals had access to 5LF2 EU Rodent Diet 14%, which was freely available to the animals at all times, except for a period of fasting from the evening of the day
prior to dosing (Day-1) until approximately 3 hours after dosing. Each batch of diet had been analysed for specific constituents and contaminants by the manufacturer.
The animal rooms were designed to permit 15 to 20 air changes per hour. The target temperature and humidity ranges were 20 to 24°C and 45 to 65% respectively. Daily recordings of maximum and minimum temperature and humidity were made.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- dispersed in 1% w/v aqueous methyl cellulose, dose volume of 10 mL/kg.
- Details on oral exposure:
- Doses were administered orally, by gavage, using plastic syringes and rubber catheters. Each
rat was dosed once on Day 1, by passing the tip of a catheter along the oesophagus and
instilling the test article into the gastric lumen. - Doses:
- Sighting Study (preliminary test)
300, 2000 mg/kg bw
Main Study
300 mg/kg bw - No. of animals per sex per dose:
- 2000 mg/kg bw: 1 female
300 mg/kg bw: 4 female - Control animals:
- no
- Details on study design:
- All animals were observed at the beginning and the end of the working day for signs of ill health or overt toxicity.
Results and discussion
- Preliminary study:
- In the preliminary study female fasted rats were given the test article as a single dose by oral
gavage at a dose level of 300 and 2000 mg/kg.
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 1 animal at 2000 mg/kg bw
- Clinical signs:
- other: Clinical signs noted in the animal treated at 2000 mg/kg were decreased activity 1 hour after dosing and tonic convulsions 2 hours after dosing. As the convulsions lasted for over 2 minutes, the animal was humanely killed. Piloerection was noted 2 and 3 h
- Gross pathology:
- No abnormalities were noted at necropsy except for pale kidneys noted in two animals treated at 300 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The test article, BI 730357 Bromchlor / IN 79479, was classified as Category 4 in respect of its acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
LD50 > 300 < 2000 mg/kg bw.
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