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EC number: 225-795-3 | CAS number: 5081-87-8
- 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:
- 2005-07-20 to 2005-10-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study, performed according to OECD Guideline 429 and Guideline ISO 10993 Biological Evaluation of Medical Devices Part 12: Sample preparation and reference materials, 2002. No deviations were recorded.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Guideline ISO 10993 Biological Evaluation of Medical Devices Part 12: Sample preparation and reference materials, 2002
- Deviations:
- no
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3-(2-chloroethyl)(1H,3H)quinazoline-2,4-dione
- EC Number:
- 225-795-3
- EC Name:
- 3-(2-chloroethyl)(1H,3H)quinazoline-2,4-dione
- Cas Number:
- 5081-87-8
- Molecular formula:
- C10H9ClN2O2
- IUPAC Name:
- 3-(2-CHLOROETHYL)QUINAZOLINE-2,4(1H,3H)-DIONE
- Details on test material:
- - Name of test material (as cited in study report): T1201 (CAS no. 5081-87-8)
- Substance type: no data
- Physical state: white to pale-beige solid
- Analytical purity: no data
- Purity test date: no data
- Lot/batch No.: 00464885 RT001201G1A251
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: at room temperature, protected from moisture
- Other:
- Solubility - 10 g/L in methanol; 7.9 g/L in ethanol; 10.2 g/L in dichloromethane; 7.6 g/L in 2-propanol; 26.7 g/L in acetone; 290 g/L in N,n-dimethyl formamide.
- Solubility in water: 0.09 g/L
- Molecular weight: 224.65 g/mol
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: nulliparous and non-pregnant female animals; Harland Netherlands
- Age at beginning of acclimatization: 6-7 weeks
- Weight at study initiation: 17.2-21.7 g (mean = 18.9 g)
- Housing: Individually in Makrolon type 1 cages with wire mesh tops and granulated soft wood bedding
- Diet (e.g. ad libitum): Pelleted standard diet, ad libitum
- Water (e.g. ad libitum): Local tap water, ad libitum
- Acclimation period: under test conditions after health examination; no further data
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 22 +/- 3 °C
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2005-10-10 To: 2005-10-11 for main experiment
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 8.25, 16.5, and 33% (w/v)
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: no data
- Irritation: A pre-test in 2 mice, and test substance concentrations of 4.125, 8.25, 16.5, 0.63, and 33% (w/v) were tested on one ear each. No irritation effects were observed at these concentrations after a single application.
- Lymph node proliferation response: no data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: Exposure to at least one test concentration must result in incorporation of 3HTdR at least three times or greater than that recorded in the control mice, as indicated by the SI, and the data must be compatable with a conventional dose reponse, although allowances must be made (especially at higher concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
- Each test group of mice was treated by topical application to the dorsal surface of each ear lobe wth the test substance at concentrations of 8.25%, 16.5%, and 33% in DMSO. 25 uL was spread over the entire surface of each ear lobe once daily for three days. Another group of mice was treated with an equal volume of DMSO alone. A hair dryer was used to dry the ear to avoid loss of test substance.
- Five days after the first application, all mice were administered 250 uL of PBS containing 80 uCi/uL 3HTdR (equal to 20 uCi 3HTdR) by IV injection via a tail vein.
- Approximately five hours after treatment with 3HTdR, all mice were euthanized by intraperitoneal injection of Na-thiopental.
- The draining lymph nodes were rapidly excised and pooled for each group (8 nodes per group).
- Cell suspensions were washed and prepared in phosphate buffered saline.
-The level of HTdR incorporation was measured on a B-scintillation counter. Background levels were also measured.
- HTdR incorporation is expressed as the number of disintegrations per minute. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- other: 2,4 dinitrobenzene sulphonic acid, sodium salt (DNBS) in 1% pluronic L92 in distilled water
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables. A statistical analysis was conducted to assess the dose-response relationship. The EC3 could not be calculated.
Results and discussion
- Positive control results:
- 5% (w/v)- Stimulation index = 1.06
10% (w/v)- Stimulation index = 1.81
25% (w/v) - Stimulation index = 4.00
EC3=18.2%
Considered to be a skin sensitizer.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 8.25% - 1.18 16.5% - 1.38 33% - 1.34
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: 8.25% (w/v) - 4645.25 16.5% (w/v) - 5410.22 33% (w/v) - 5268.12 per lymph node: 8.25% (w/v) - 580.66 16.5% (w/v) - 676.28 33% (w/v) - 658.52
Any other information on results incl. tables
Observations:
-No mortality occurred during the study period.
-No symptoms of local toxicity and no systemic findings were observed during the study period.
-The body weights of the animals were within normal ranges for this strain and age.
Positive Control Local Lymph Node Assay in the Mouse (2005)
Project Number |
Start Date |
Finish Date |
Test Material |
Concentration |
Vehicle |
Stimulation Indexa |
Classificationb |
039/747· |
04/03/2005 |
10/03/2005 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
acetone/olive oil 4:1 |
2.76, 3.34, 8.91 |
Positive |
039/750* |
20/04/2005 |
26/04/2005 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
ethanol/distilled water |
2.64, 8.36, 12.94 |
Positive |
039/769A* |
14/07/2005 |
20/07/2005 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
1% pluronic L92 in distilled water |
0.86, 1.50, 6.17 |
Positive |
039/769B* |
14/07/2005 |
20/07/2005 |
2,4 Dinitrobenzene sulphonic acid, sodium salt (DNBS) |
1%, 10%, 20% v/v |
1% pluronic L92 in distilled water |
1.16, 9.59, 20.71 |
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 and therefore is considered not to be classified.
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