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EC number: 617-648-0 | CAS number: 849727-62-4
- 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:
- disregarded due to major methodological deficiencies
- Study period:
- 2003-05-20 to 2003-06-10
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- significant methodological deficiencies
- Remarks:
- The study was conducted following SPL Standard Test method 595.12. However, very low doses were selected without justification. Study report was limited. Therefore a K score of 3 is assigned to this study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- SPL Standard Test Method 595.12. : 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 radiolabelled 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 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:
- 3-(2-CHLOROETHYL)-9-HYDROXY-2-METHYL-4H-PYRIDO[1,2-A]PYRIMIDIN-4-ONE HYDROCHLORIDE (1:1)
- EC Number:
- 617-648-0
- Cas Number:
- 849727-62-4
- Molecular formula:
- C11H11ClN2O2.HCl
- IUPAC Name:
- 3-(2-CHLOROETHYL)-9-HYDROXY-2-METHYL-4H-PYRIDO[1,2-A]PYRIMIDIN-4-ONE HYDROCHLORIDE (1:1)
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): HT 002006
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS: no data
ENVIRONMENTAL CONDITIONS: no data
IN-LIFE DATES: no data
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0.25%, 0.5% and 1% w/w
- No. of animals per dose:
- four/dose group
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: no data
- Irritation: In a preliminary sighting test, no deaths or signs of systemic toxicity were observed at a concentration of 1%.
- Lymph node proliferation response: no data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA, the test is designed to assess the skin sensitising potential (delayed-type hypersensitivity) of the test substance.
- Criteria used to consider a positive response: Test-to-control ratio greater than 3.0 indicated a positive result.
TREATMENT PREPARATION AND ADMINISTRATION:
- Three groups, each of four animals, were treated with 50 uL (25 uL per ear) of the test substance as a solution in dimethyl formamide at concentrations of 0.25%, 0.5%, and 1% v/v. A further group of four animals was treated with dimethyl formamide alone. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- no data
Results and discussion
- Positive control results:
- see: any other information on results (here below)
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.84
- Test group / Remarks:
- 0.25% w/w
- Parameter:
- SI
- Value:
- 1.39
- Test group / Remarks:
- 5% w/w
- Parameter:
- SI
- Value:
- 2.55
- Test group / Remarks:
- 1% w/w
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 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:
- study cannot be used for classification
- Conclusions:
- The test material was considered to be a non-sensitiser under the conditions of the test and should therefore not be classified.
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