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EC number: 428-190-4 | CAS number: 68490-66-4 CUREZOL 2MA-OK
- 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:
- 12 Jun to 27 Jun 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- Adopted 24 Apr 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- EEC Methods for the determination of toxicity. Annex to Commission Directive 2004/73/EC (Official Journal No. L152, 30.4.2004), Part B
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of Health of the Government of the United Kingdom, London, England
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: harlan UK Ltd., Bicester, Oxon, England
- Females (if applicable) nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: not specific pathogen-free (SPF) animals
- Age at study initiation: eight to twelve weeks
- Weight at study initiation: 16.1 to 22.6 g
- Housing: housed individually in polycarbonate cages with woodflake bedding, provided Nestlets for environmental enrichment
- Diet: Special Diet Services RMI (E) SQC, ad libitum
- Water: municipal drinking water, ad libitum
- Acclimation period: at least six days
- Indication of any skin lesions: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2
- Humidity (%): 40 to 70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
- IN-LIFE DATES: From: 12 Jun 2006 To: 27 Jun 2006
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 10, 20, 50% w/v
- No. of animals per dose:
- 4
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Lymph node 3H-methyl Thymidine (3HTdR) incorporation determined by Β-scintillation counting.
- Criteria used to consider a positive response: The test substance is condsidered as a sensitizer if at least one concentration of the test substance results in a three-fold greater increase in 3HTdR incorporation compared to control values.
TREATMENT PREPARATION AND ADMINISTRATION: Groups of four mice were treated at one of three concentrations of the test substance. The mice were treated by daily application of 25 µL of the appropriate concentration of the test substance to the entire dorsal surface of each ear for three consecutive days (Days 1-3) using a micropipette for evenly-spread application. A further two groups of four mice received the vehicle alone or the positive control substance (HCA). All animals were observed daily for signs of toxicity and local ear irritations were assessed. The maxiumum practical concentration for pinna dosing was 50% (w/v). Five days following the first topical application of the test substance (Day 6), all mice were injected via tail vein with 250 µL of PBS containing 3HTdR giving a nominal dose of 20 µCi to each mouse. Five hours later, the draining auricular lymph node of each ear was excised into PBS, lymph nodes being pooled per treatment group. A single cell suspension of lymph nodes (LNC) was prepared by gentle mechanical disaggregation, washed, pelleted (by centrifugation), and resuspended three times in PBS. The final resuspension was in trichloroacetic acid (TCA: 5%). Macromolecules were precipitated with 5% TCA at 4 °C overnight. The precipitate was pelleted by centrifugation, resuspended in 5% TCA, added to Ultima Gold scintillation cocktail and measured by B-scintillation counting. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Body weight means and test/control ratios were calculated.
Results and discussion
- Positive control results:
- The test/control ratio for the HCA-treated group was 9.8. A three-fold greater increase compared to control values indicates a sensitizer. This test/control ratio value showed the effectiveness of the positive control treatment.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- other: Test/control ratio
- Value:
- 0.8
- Variability:
- pooled results per group
- Test group / Remarks:
- 10% (w/v)
- Key result
- Parameter:
- other: Test/control ratio
- Value:
- 1.2
- Variability:
- pooled results per group
- Test group / Remarks:
- 20% (w/v)
- Key result
- Parameter:
- other: Test/control ratio
- Value:
- 1.4
- Variability:
- pooled results per group
- Test group / Remarks:
- 50% (w/v)
- Cellular proliferation data / Observations:
- DETAILS ON STIMULATION INDEX CALCULATION
Disintegrations per minute (DPM):
Group Concentration % (w/v) DPM Number of lymph nodes DPM/node Test/control (+) = positive
ratio (-) = negative
1 DMSO 2510.70 8 313.84 NA NA
2 10 2047.50 8 255.94 0.8 (-)
3 20 2910.00 8 363.75 1.2 (-)
4 50 3630.90 8 453.86 1.4 (-)
5 HCA 24646.90 8 3080.86 9.8 (+)
CLINICAL OBSERVATIONS: There were no deaths or signs of ill health or toxicity observed during this study. Reddening of the skin around the cranial area was noted after dosing in three animals in Group 5 (HCA) on Day 3 (final application), this had resolved by Day 4.
BODY WEIGHTS: One female (Group 2) lost body weight during the study. All remaining animals gained weight during the study.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
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.
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