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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov. 2016 - Mar. 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted to meet the known requirements of Method B46 of Council Regulation (EC) No 761/2009 and OECD Guidelines for Testing of Chemicals Method 439 (adopted 28 July 2015).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes
- Remarks:
- given by compliance statement with signature
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
In vitro test system
- Test system:
- human skin model
- Remarks:
- skin model EpiDermTM SIT (EPI-200)
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- other: deionised water and isopropanol
- Details on test system:
- EpiDermTM SIT (EPI-200) tissues were kept in their packaging until the next step. The tissues were set up the day prior to treatment by placing each tissue onto 0.9 mL maintenance medium (supplied with the EpiDermTM SIT (EPI-200) tissues) in 6-well plates and incubating at 37°C.
Experiment 1:On a total of three tissues per test article, negative and positive
control. A further test was conducted on a total of 6 tissues per test article, and three per
negative and positive control.
25 mg of the test article was added topically to the tissues. In the first experiment the tissues
were moistened with 25 μL of PBS, prior to application. In the second experiment an extra
treatment condition was included, omitting the 25 μL of PBS prior to application. A volume
of 30 μL of the positive and negative control solutions was used.
In the first experiment the treated tissues were paced into an incubator at 37±1ºC, 5±1% CO2
for 35 minutes. The plates were removed from the incubator and placed into a sterile hood
until the 60 minute treatment period was complete for each tissue. Following treatment,
substances were removed by washing the tissues. The tissues were then placed on the
appropriate medium and incubated for 41 hours and 50 minutes.
Experiment 2:
The treated tissues were paced into an incubator at 37±1ºC, 5±1%
CO2 for 35 minutes. The plates were removed from the incubator and placed into a sterile
hood until the 60 minute treatment period was complete for each tissue. Following treatment,
substances were removed by washing the tissues. The tissues were then placed on the
appropriate medium and incubated for 40 hours and 15 minutes - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- yes, concurrent MTT non-specific colour control
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1
- Value:
- 62.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100 %
- Positive controls validity:
- valid
- Remarks:
- 3.3 %
- Remarks on result:
- other:
- Remarks:
- The standard deviation for test article treated tissues was >18%. Therefore this assay acceptance criterion was not met.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 2
- Value:
- 8.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 100 %
- Positive controls validity:
- valid
- Remarks:
- 2.8 %
- Remarks on result:
- other: Result is for not moistened tissues
- Remarks:
- The standard deviation for pre-moistened, test article treated tissues was >18%. Therefore this assay acceptance criterion was not met. The assay acceptance criterion was met for those tissues that were not moistened.
Applicant's summary and conclusion
- Interpretation of results:
- other: considered to be irritant
- Conclusions:
- The test article, IN 79479, was considered to be irritant in the in vitro skin model EpiDermTM
As no study is available for corrosion and the EpiDermTM can't differ between corrosion/irritation, IN 79479 was classified with H314.
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.