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EC number: 237-335-9 | CAS number: 13752-51-7
- 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:
- 28 June 2010 to 21 July 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study, conducted according to international guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4-[(morpholinothio)thioxomethyl]morpholine
- EC Number:
- 237-335-9
- EC Name:
- 4-[(morpholinothio)thioxomethyl]morpholine
- Cas Number:
- 13752-51-7
- Molecular formula:
- C9H16N2O2S2
- IUPAC Name:
- morpholin-4-yl morpholine-4-carbodithioate
- Details on test material:
- - Name of test material (as cited in study report): Cure-rite 18
- Chemical Name: 4-[(morpholinothio)thioxomethyl] morpholine
- Substance type: cure accelerator for rubber
- Physical state: white to off white powder
- Analytical purity: >95%
- Lot/batch No.: HY10ECC15
- Expiration date of the lot/batch: 28 June 2011
- Storage condition of test material: ca. 4°C in a refrigerator
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Commercial laboratory animal supplier
- Age at study initiation: approx 8 to 12 weeks
- Weight at study initiation: 16.7 - 22.9 g
- Housing: polycarbonate cages with woodflake bedding, in barriered rodent facility
- Diet : ad libitum to a standard rodent diet
- Water : ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 23 °C
- Humidity (%): 40 - 70 %
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hrs dark
IN-LIFE DATES: From: 30 June 2010 To: 19 July 2010
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 10, 25 and 50% w/v
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Cure-rite 18 formed a white suspension at 50% w/v in acetone:olive oil.
- Irritation: no sign of irritation were seen over the dosed area.
- Lymph node proliferation response: none noted
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay (LLNA)
- Criteria used to consider a positive response: Lymphocyte proliferation in lymph nodes draining the site of application was assessed during the sensitizing phase of the response by measuring the incorporation of radiolabelled Thymidine. Test substance is regarded as a sensitizer if at least one concentration of the test substance results in a three-fold greater increase in 3HTdR (3H-methyl Thymidine) incorporation to control values.
TREATMENT PREPARATION AND ADMINISTRATION: maximum practical concentration for pinna dosing was 50% w/v in acetone:olive oil 4:1 v/v as determined in the range-finding test. The doses were applied to the entire dorsal surface of each ear using an automatic micropipette. The vehicle in the control group was applied in the same manner. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Test/Control ratios were calculated
Results and discussion
- Positive control results:
- The sensitivity of the mouse strain used is checked periodically at Huntingdon Life Sciences Ltd. with hexyl cinnamic aldehyde (HCA), a known moderate sensitizer. Responses to HCA in contemporaneous studies demonstrate the reliability and sensitivity of this assay to detect skin sensitization potential in this laboratory.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- < 3
- Test group / Remarks:
- 10%
- Remarks on result:
- other: a value of less than 3 was observed for all groups.
- Parameter:
- SI
- Value:
- < 3
- Test group / Remarks:
- 25%
- Remarks on result:
- other: a value of less than 3 was observed for all groups.
- Parameter:
- SI
- Value:
- < 3
- Test group / Remarks:
- 50%
- Remarks on result:
- other: a value of less than 3 was observed for all groups.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: control - 3451.35 dpm 10% w/v - 4848.05 dpm 25% w/v - 4708.45 dpm 50% w/v - 6213.35 dpm
Any other information on results incl. tables
Test/control ratios:
10%w/v: 1.4
25%w/v: 1.4
50%w/v: 1.8
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Cure-rite 18 is not regarded as a potential skin sensitizer.
- Executive summary:
The study was performed to assess the skin sensitization potential of Cure-rite 18 using the murine local lymph node assay (LLNA). In this assay the test/control ratios obtained for 10, 25 and 50% w/v were 1.4, 1.4 and 1.8 respectively which indicates that Cure-rite 18 did not show the potential to induce skin sensitization (delayed contact hypersensitivity).
Responses to the positive control substance hexyl cinnamic aldehyde (HCA), in a contemporaneous study demonstrate the reliability and sensitivity of this assay to detect skin sensitization potential in this laboratory.
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