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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 607-384-4 | CAS number: 244768-32-9
- 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:
- other: The study was conducted following SPL Standard Test method 595.12.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: SPL Standard Test Method 595.12
- 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-CHLOROPYRIMIDIN-2-YL)AMINO]BENZONITRILE
- EC Number:
- 607-384-4
- Cas Number:
- 244768-32-9
- Molecular formula:
- C11H7ClN4
- IUPAC Name:
- 4-[(4-CHLOROPYRIMIDIN-2-YL)AMINO]BENZONITRILE
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study reports): JNJ-4754724-AAA (T002488)
- Physical state: solid
- Appearance: light brown powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Janssen Pharmaceutica N.V.
- Expiration date of the lot/batch: No data
- Purity test date: No data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: No data
- Stability under test conditions: No data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No data.
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- 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: 15 to 22 grams
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data
ENVIRONMENTAL CONDITIONS:
- Temperature (deg C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- vehicle alone, 2.5%, 5% and 10% w/w
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Following a preliminary sighting test, no signs of systemic toxicity were observed at a concentration of 10% 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 four animals were treated with 50 µL (25µuL per ear) of the test substance as a solution in dimethyl formamide at concentrations of 2.5%, 5% and 10% 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
- Statistics:
- No statistical analysis was used.
Results and discussion
- Positive control results:
- see tables below
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.81
- Test group / Remarks:
- 4 animals in 2.5% w/w in DMF group
- Parameter:
- SI
- Value:
- 2.25
- Test group / Remarks:
- 4 animals in 5% w/w in DMF group
- Parameter:
- SI
- Value:
- 1.91
- Test group / Remarks:
- 4 animals in 10% w/w in DMF group
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
DPM:
- 2.5% = 11089.82 (1386.23/node)
- 5% = 13787.05 (1723.38/node)
- 10% = 11719.21 (1464.90/node)
- Vehicle Only = 6129.19 (766.15/node)
EC3 CALCULATION
- Not applicable
CLINICAL OBSERVATIONS:
-No mortality or clinical observations were observed.
BODY WEIGHTS:
- No unusualy changes in body weight were observed.
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 substance was considered to be a non-sensitiser under the conditions of the test.
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.