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EC number: 271-272-8 | CAS number: 68527-63-9
- 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:
- 2018-05-24 to 2018-06-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The LLNA was required as the in vitro skin sensitisation studies OECD 442C and 442D did not gave adequate information for uniformly convincing substance classification.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- Version / remarks:
- 2010-07-22
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
Test material
- Reference substance name:
- Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1)
- EC Number:
- 271-272-8
- EC Name:
- Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1)
- Cas Number:
- 68527-63-9
- Molecular formula:
- C22H42N2O.C4H10O4S
- IUPAC Name:
- 2-{2-[(8E)-heptadec-8-en-1-yl]-4,5-dihydro-1H-imidazol-1-yl}ethan-1-ol diethyl sulfate
- Test material form:
- liquid
- Details on test material:
- Test item formulations were found to be homogeneous and stable up to 24 hour in vehicle corn oil.
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: R-127, lot 170825
- Expiration date of the lot/batch: 2019-06-19
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- Balb/c
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: InVivos Pte Ltd
9 Perahu Road,
Lim Chu Kang,
Singapore 718793
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 16.7 - 20.6 g
- Housing: OptiMICE Caging Systems
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 1 week
- Indication of any skin lesions: none
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26 °C
- Humidity (%): 30 - 70 %
- IN-LIFE DATES: From: 2018-05-17 To: 2018-06-27
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 1 %, 0.5 %, 0.25 %
- No. of animals per dose:
- 3
- Details on study design:
- Administration of test substances
Administration Topical application on dorsum of both ears
Dose level 25 µl for each ear
Dose Interval Topical application of 25 µl of test substances/negative control/positive control on the dorsum of each ear once a day for 3 consecutive days
Dosing Date 21 Jun 2018 – 23 Jun 2018
Administration of BrdU (10 mg/ml)
Administration Intraperitoneal injection (IP)
Dose level 5 mg (0.5ml of 10 mg/ml solution) per mice
Dose Interval Single Dose
Dosing Date 25 Jun 2018 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Results for each test and control group were expressed as mean Stimulation Index (SI). The SI was derived by dividing the mean BrdU labelling index of test or positive control group by the mean BrdU labelling index of negative control group. The SI for negative control group was defined as 1.
BrdU labelling index (LI) = (Mean ABS450-Mean ABSblank 450) – (Mean ABS690-Mean
ABSblank 690)
SI = LI test (positive control) / LI negative control
Based on OECD Guideline 442B, SI of 1.6 or more (≥ 1.6) is considered positive for designating a test sample as a sensitizer. The positive control usually produces a SI of ≥ 1.6.
Results and discussion
- Positive control results:
- Valid
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 1.742
- Test group / Remarks:
- 0.25 % test item
- Parameter:
- SI
- Value:
- 1.955
- Test group / Remarks:
- 0.5 %
- Parameter:
- SI
- Value:
- 2.89
- Test group / Remarks:
- 1 %
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Based on the above study, using 1%, 0.5% and 0.25% (v/v) of the test item – diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1), as test substances and acetone : Olive oil (4:1, v/v) as vehicle and negative control, skin sensitization was produced in mice.
- Executive summary:
The potential of diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1) to cause skin sensitisation was examined in a study according to OECD 442B.
Based on the above study, using 1%, 0.5% and 0.25% (v/v) of the test item – diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1), as test substances and acetone : Olive oil (4:1, v/v) as vehicle and negative control, skin sensitization was produced in mice.
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