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EC number: 606-195-4 | CAS number: 189956-45-4
- 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:
- 2004-11-01 to 2004-12-07
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: SPL Standard Test Method 595.12
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- The assay determines the level of lymphocyte proliferation in lymph nodes draining the application site of the test material. Determination of lymphocyte proliferation is quantified by measuring the incorporation of radiolabeled thymidine in the dividing lymph node cells. The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (dpm/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).
- 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 had not been audited by the QA Unit. No formal claim of GLP compliance was made for the study.
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-[(4-Oxo-1,4-dihydropyrimidin-2-yl)amino]benzonitrile
- EC Number:
- 606-195-4
- Cas Number:
- 189956-45-4
- Molecular formula:
- C11H8N4O
- IUPAC Name:
- 4-[(4-Oxo-1,4-dihydropyrimidin-2-yl)amino]benzonitrile
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): JNJ-40370226-AAA (T002487)
- Physical state: solid (powder)
- Appearance: Off-white powder
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): T2487
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 16 to 21 grams
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS: no data
IN-LIFE DATES: no data
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- vehicle alone, 0.5%, 1% and 2.5% w/w
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: no data
- Irritation: no data
- Lymph node proliferation response: no data
- other: Following a preliminary sighting test, no signs of systemic toxicity were observed at a concentration of 2.5% w/w.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: a stimulation Index of greater than 3.0
TREATMENT PREPARATION AND ADMINISTRATION:
- Three groups, each of 4 animals, were treated with 50 uL (25 uL per ear) of the test substance as a solution in dimethyl formamide at concentrations of 0.5%, 1% and 2.5% w/w. A further group of four animals was treated with dimethyl formamide alone. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- other: 2,4 Dinitrobenzenesulfonic acid, sodium salt, at 1%, 10%, 20% v/v in 1% pluronic F-68 in distilled water
Results and discussion
- Positive control results:
- See field 'Any other information on results incl. tables)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.15
- Test group / Remarks:
- 0.5% w/w group / mean results of 4 animals
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 1% w/w group / mean results of 4 animals
- Parameter:
- SI
- Value:
- 0.96
- Test group / Remarks:
- 2.5% w/w group / mean results of 4 animals
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
Dpm/Node obtained by dividing Dpm value by 8 (total number of lymph nodes):
Vehicle control group: 532.54
0.5 % w/w group: 610.17
1 % w/w group: 692.79
2.5 % w/w group: 512.43
DETAILS ON STIMULATION INDEX CALCULATION
The Stimulation Index (SI) expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group is reported for each test group in the results table above
EC3 CALCULATION
No EC3 value could be calculated as the mean SI values for each group were below 3.
CLINICAL OBSERVATIONS:
No signs of systemic toxicity
BODY WEIGHTS
Body weights and body weight gain of experimental animals remained in the same range as controls over the study period.
Any other information on results incl. tables
Positive Control Local Lymph Node Assay in the Mouse (2004)
Start Date |
Finish Date |
Test Material |
Concentration |
Vehicle |
Stimulation Indexa |
Classificationb |
29/04/2004 |
05/05/2004 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
acetone/olive oil 4:1 |
1.40, 2.23, 6.09 |
Positive |
29/04/2004 |
05/05/2004 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
acetone/olive oil 4:1 |
1.74, 2.20, 8.89 |
Positive |
14/10/2004 |
26/10/2004 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
tetrahydrofuran |
1.97, 3.71, 7.82 |
Positive |
29/09/2004 |
05/10/2004 |
2,4‑Dinitrobenzenesulfonic acid, sodium salt |
1%, 10%, 20% v/v |
1% pluronic F-68 in distilled water |
1.03, 4.41, 13.55 |
Positive |
27/10/2004 |
02/11/2004 |
α‑Hexylcinnamaldehyde, tech., 85% |
10%, 25%, 50% v/v |
cottonseed oil |
1.52, 2.63, 5.07 |
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 item was considered to be a non-sensitiser under the conditions of the test.
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