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EC number: 214-288-2 | CAS number: 1119-86-4
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with regulatory guidelines OECD429 and EU B.42 and to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
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:
- Decane-1,2-diol
- EC Number:
- 214-288-2
- EC Name:
- Decane-1,2-diol
- Cas Number:
- 1119-86-4
- Molecular formula:
- C10H22O2
- IUPAC Name:
- decane-1,2-diol
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Decan-1,2-diol
- CAS number: 1119-86-4
- EC number: 214-288-2
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Test animals: CBA/CaOlaHsd mice
- Source: Harlan NetherlandsB.V. Postbus 6174
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 16-24g
- Housing: Single Makrolon type-2 cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3 C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12 hour fluorescent light- 12 hours dark
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, open
- Vehicle:
- other: acetone : olive oil (AOO) 4:1 (v/v)
- Concentration / amount:
- 5, 10, 25 and 50%
Challengeopen allclose all
- Route:
- other: none
- Vehicle:
- other: acetone : olive oil (AOO) 4:1 (v/v)
- Concentration / amount:
- 5, 10, 25 and 50%
- No. of animals per dose:
- Four
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Once daily for three consecutive days
- Exposure period: 24 hours for each of the three days
- Test groups: 4
- Control group: 1
- Site: dorsal surface of both ear lobes
- Frequency of applications: once daily
- Duration: 3 days
- Concentrations: 5, 10, 25 and 50%
- Administraton of 3H-methyl thymidine: Five days after the first topical application, all mice were administered with 250 µl of 83.1 µCi/ml 3HTdR by intravenous injection via a tail vein.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 10, 25 and 50%
- No. of animals per dose:
- Four
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: Not reported
- Irritation: Not reported
- Lymph node proliferation response: Not reported
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local lymph node assay
- Criteria used to consider a positive response: Stimulation Index >3
TREATMENT PREPARATION AND ADMINISTRATION:
Topical (epidermal) application to dorsal surface of each ear lobe. A volume of 25 uL was spread over the entire dorsal surface (0-8mm) once daily for 3 consecutive days.
Five days after the first topical application, all mice were administered with 250uL of 83.1uCi/mL 3H methyl thymidine by intravenous injection into the tail vein. Five hours later animals were killed and draining lymph nodes excised and pooled for each experimental group i.e. 8 per group apart from group 3 (10%) where only 7 nodes were extracted. - Statistics:
- Mean value and standard deviations for bodyweights only.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Control - 1 5% -2.4 10% -2.7 25% - 1.6 50% - 2.2 Calculation of the EC3 value was not possible as an SI of 3 or higher was not reached in the study.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Control - 1381 (pooled); 173 per lymph node 5% - 3334 (pooled); 417 per lymph node 10% - 3304 (pooled); 471 per lymph node (only 7 lymph nodes collected) 25% - 2207 (pooled); 275 per lymph node 50% - 3099 (pooled); 387 per lymph node
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU CLP
- Conclusions:
- Not sensitising. No signs of local toxicity at the application site was noted.
- Executive summary:
Four groups each of four female mice were treated daily with the test item at a concentration of 5, 10, 25 or 50% (w/v) in acetone : olive oil 4:1 (w/v) by topical application to the dorsal surface of each ear lobe for three consecutive days. A control group of four mice was treated with the vehicle. Five days after the first topical application, the mice were injected intravenously with radio-labelled thymidine. Approximately five hours after intravenous injection, the mice were sacrificed and the draining auricular lymph nodes excised and pooled per group. Single cell suspensions of lymph node cells were prepared from pooled lymph nodes which were subsequently washed and incubated with trichloroacetic acid overnight. The proliferative capacity of pooled lymph node cells was determined by incorporation of 3H methyl thymidine measured in a beta scintillation counter.
Disintegrations per minute were determined per lymph node sample and Stimulation Indices (SI) relative to control group were calculated as follows:
5% SI= 2.4
10% SI = 2.7
25% SI = 1.6
50% SI= 2.2
Calculation of the EC3 value was not possible as a SI of 3 or higher was not reached in the study.
Decan-1,2-diol at concentrations up to 50% was found not to be a skin sensitiser.
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