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EC number: 435-030-7 | CAS number: -
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 435-030-7
- EC Name:
- -
- Cas Number:
- 26452-81-3
- Molecular formula:
- C5H5N2OCl
- IUPAC Name:
- 4-chloro-6-methoxypyrimidine
- Test material form:
- other: solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 3004 - 3154 g
- Housing: individually, in cages suitable for animals of this strain and the weight range expected during the course of the study
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): ≥15
- Photoperiod (hrs dark / hrs light): 12 / 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: other eye of the same animal
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 100 mg into the conjunctival sac of the left eye. The lids were then gently held together for 1 - 2 seconds. - Duration of treatment / exposure:
- once
- Observation period (in vivo):
- 4 days
- Number of animals or in vitro replicates:
- 1 female, 2 males
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: No
SCORING SYSTEM: The eyes were examined and the Draize scale was used to assess the grade of ocular reaction approx. 1 hour and 1, 2, 3, and 4 days after application.
TOOL USED TO ASSESS SCORE: fluorescein
OTHER: Immediately after the application of the test substance, an assessment of the initial pain reaction of the rabbit was made using a six-point scale.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No corneal opacity noted during the course of the study
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No corneal opacity noted during the course of the study
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: No corneal opacity noted during the course of the study
- Irritation parameter:
- iris score
- Basis:
- animal: #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- animal: #2
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- iris score
- Basis:
- animal: #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 4 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal: #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- There were no corneal effects. Slight iritis was seen in all animals for up to 3 days. Conjunctival effects were seen in all animals and consisted of slight or moderate redness for 3 days, slight or mild chemosis for up to 2 days and a slight or moderate discharge for up to 1 day. Additional signs of irritation comprised lachrymatory or mucoid discharge and dried secretion around the periorbital skin. One animal was holding its dosed eye closed approximately 1 hour after application, which may be indicative of pain. All signs of irritation had completely resolved 4 days after application.
- Other effects:
- There were no signs of ill-health in any animal during the study.
Application into the eye caused practically no or slight initial pain (class 1 - 2 on a 0 - 5 scale).
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is considered to be slightly irritating to the rabbit eye.
- Executive summary:
In a GLP compliant eye irritation study, performed according to OECD guideline 405, the test substance (100 mg) was applied into one eye of three New Zealand White rabbits. An assessment of initial pain was made and the eyes were examined for 4 days to assess the grade of ocular reaction. Application into the eye caused practically no or slight initial pain (class 1 - 2 on a 0 - 5 scale). There were no corneal effects. Slight iritis was seen in all animals for up to 3 days. Conjunctivae effects were seen in all animals and consisted of slight or moderate redness for 3 days, slight or mild chemosis for up to 2 days and a slight or moderate discharge for up to 1 day. Additional signs of irritation comprised lachrymatory or mucoid discharge and dried secretion around the periorbital skin. One animal was holding its dosed eye closed approximately 1 hour after application, which may be indicative of pain. All signs of irritation had completely resolved 4 days after application. Under the conditions of this experiment, the test substance was found to be slightly irritating. All observed effects were non-classifiable.
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