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EC number: 609-425-1 | CAS number: 374067-80-8
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-05-20 to 2003-06-11
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not specified
- Remarks:
- not specified/limited data provided on methodology
- Principles of method if other than guideline:
- SPL Standard Test Method 595.12
- GLP compliance:
- no
- Remarks:
- The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA unit. No formal claim of GLP compliance is made for this study.
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-[(4,6-dihydroxypyrimidin-2-yl)amino]benzonitrile
- EC Number:
- 609-425-1
- Cas Number:
- 374067-80-8
- Molecular formula:
- C11H8N4O2
- IUPAC Name:
- 4-[(4,6-dihydroxypyrimidin-2-yl)amino]benzonitrile
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): JNJ-4370561-AAA (T002326)
- Physical state: solid (powder)
- Appearance: slight beige powder
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS: no data
ENVIRONMENTAL CONDITIONS: no data
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 2.5, 5, and 10% w/w
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: no data
- Irritation: Following a preliminary sighting test, no death or signs of systemic toxicity were observed at a concentration of 10% w/w in DMSO.
- Lymph node proliferation response: no data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: Test to control ratio for stimulation Index greater than 3.0 indicates a 'positive' result
TREATMENT PREPARATION AND ADMINISTRATION:
- three groups of four animals were treated with 25 µL per ear of 2.5, 5, and 10% test material in dimethyl sulfoxide. A further group of four animals was treated with dimethyl sulfoxide alone. Determination of lymphocyte proliferation was quantified by measuring the incorporation of radiolabelled thymidine in the dividing lymph node cells. The proliferation response of the lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node and as the ratio of ³HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- see: any other information on results (here below)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 2.05
- Test group / Remarks:
- 2.5% w/w group
- Parameter:
- SI
- Value:
- 1.67
- Test group / Remarks:
- 5% w/w group
- Parameter:
- SI
- Value:
- 1.95
- Test group / Remarks:
- 10% w/w group
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA: no data
DETAILS ON STIMULATION INDEX CALCULATION: The Stimulation Index (SI) was expresssed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group.
EC3 CALCULATION: no data
CLINICAL OBSERVATIONS: no data
BODY WEIGHTS: no data
Any other information on results incl. tables
Positive Control Local Lymph Node Assay in the Mouse (2003)
Start Date |
Finish Date |
Test Material |
Concentration |
Vehicle |
Stimulation Indexa |
Classificationb |
13/03/2003 |
19/03/2003 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
acetone/olive oil 4:1 |
2.8, 2.3, 5.5 |
Positive |
13/03/2003 |
19/03/2003 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
acetone/olive oil 4:1 |
2.0, 1.9, 6.8 |
Positive |
10/10/2003 |
16/10/2003 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
acetone/olive oil 4:1 |
1.76, 2.78, 5.06 |
Positive |
16/10/2003 |
22/10/2003 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
acetone/olive oil 4:1 |
1.49, 1.73, 5.26 |
Positive |
a= Ratio of test to control lymphocyte proliferation
b= Stimulation index greater than 3.0 indicates a positive result
* = Standard Test Method 595 (Pooled nodes)
·= Standard Test Method 599 (Individual nodes)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was not considered to be a skin sensitizer as the test to control ratio for the stimulation index didn't exceed 3.0 in all dose groups.
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