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EC number: 230-029-6 | CAS number: 6920-22-5
- 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:
- from April 23, 2003 to April 29, 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline test with GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (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:
- DL-hexane-1,2-diol
- EC Number:
- 230-029-6
- EC Name:
- DL-hexane-1,2-diol
- Cas Number:
- 6920-22-5
- Molecular formula:
- C6H14O2
- IUPAC Name:
- hexane-1,2-diol
- Reference substance name:
- 1,2-hexandiol
- IUPAC Name:
- 1,2-hexandiol
- Test material form:
- other: clear, liquid
- Details on test material:
- CAS No.: 6920-22-5
EC No.: 230-029-6
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Test Animals
Mice, CBA/Ca01aHsd, female, age 7-12 weeks, 5 mice per test group
The animals were derived from a controlled full barrier maintained breeding system (SPF).
Source: Harlan Winkelmann GmbH, D-33178 Borchen.
According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals are bred for experimental purposes.
Animal Husbandry
The animals were barrier maintained (semi-barrier) in an air conditioned room
- Temperature: 22 ± 30C -Rel. humidity: 55 ±10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Feeding ad libitum, Altromin 1324 maintenance diet for rats and mice, totally-pathogen-free (TPF)
- Free access to tap water (drinking water, municipal residue control, microbioL controlled periodically)
- The animals were kept in groups in Macrolon - cages on Altromin saw fiber bedding
- Certificates of food, water and bedding are filed at BSL Bio service
- Adequate acclimatisation period
Study design: in vivo (LLNA)
- Vehicle:
- other: AOO (3+1 (v/v) Acetone/Olive Oil)
- Concentration:
- at three concentrations of 100 %, 50 % and 10 % (w/w) respectively.
- No. of animals per dose:
- 5
- Details on study design:
- Preparation of the Animals
The animals were randomly selected.
Identification was ensured by cage number and individual marking (tail).
Test Regime:
Topical Application
Each mouse was treated by topical application of 25 µl of the selected solution to the entire dorsal surface of each ear.
Topical applications were performed once daily over three consecutive days. Administration of 3H-methyl thymidine
Five days after the first topical application treatment all mice were dosed with 20 µCi 3H-methyl thymidine by intravenous injection (tail vein) of 250 µl of 3H-methyl thymidine, diluted to a working concentration of 80 µCi/mL
Preparation of cell suspension
Approximately 5 hours after H-methyl thymidine-injection all mice were sacrificed. The draining "auricular lymph nodes“ were excised, weighed individually pooled for each animal (2 lymph nodes per animal, if technically possible) and collected in PBS. A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through polyamid gauze (200 mesh size). After washing the gauze with PBS the cell suspension was pelleted in a centrifuge. The supernatant was discarded and the pellets were resuspended with PBS. This washing procedure was repeated twice.
After the final wash each pellet was resuspended in approx. 3 ml 5% TCA at approx. 4 °C overnight for precipitation of macromolecules. Each precipitate was recovered by centrifugation, resuspended in 1 ml 5% TCA and transfered into scintillation vials.
Determination of incorporated 3H-methyl thymidine
The 3H-methyl thymidine - incorporation was measured in a β-counter and expressed as the number of disintegrations per minute (DPM). Similarly,
background 3H-methyl thymidine levels were also measured (5% TCA). Determination of radioactivity was performed individually for each animal.
If all measured points are above or below the stimulation index of three, no EC3 value can be stated. A substance is regarded as a 'sensitizer' in the LLNA if at least one concentration of the test item results in a 3 fold or greater increase in 3H-methyl thymidine - incorporation into lymph node cells of the lymph nodes of the test group animals, relative to that recorded for the lymph nodes of control group animals (Stimulation Index equal to or greater than 3.0.). - Positive control substance(s):
- not specified
- Statistics:
- A substance is regarded as a 'sensitizer' in the LLNA if at least one concentration of the test item results in a 3 fold or greater increase in 3H-methyl thymidine - incorporation into lymph node cells of the lymph nodes of the test group animals, relative to that recorded for the lymph nodes of control group animals (Stimulation Index equal to or greater than 3.0.).
Results and discussion
- Positive control results:
- no data
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: 100%: 0.6 50%: 1.9 10%: 1.6
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: negative control: 29.5 ±1.7; 10%: 33.2 ±8.3; 50%:35.6 ±11.1; 100%: 26.6±8.6
Any other information on results incl. tables
The EC3 value (derived by linear interpolation) could not be stated because all measure points were below three.
All animals survived throughout the test period without showing any clinical signs. Weight gain of all animals was within the expected range.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the data given in this study, the test item caused no sensitization as the stimulation index was below 3.0 for each concentration tested.
- Executive summary:
This study was conducted following to OECD guideline 429 and 406 and GLP principles. Each mouse was exposed to the prepared test article at three concentrations of 100%, 50% and 10% (w/w) respectively by topical application to the entire dorsal surface of each ear once daily over three consecutive days. Five days after the first application all mice were injected intravenoulsy with 3H-methyl thymidine. 5 hours after injection all mice were sacrified and the draining were excised and weighted individually. The stimulation index at concentrations of 100%, 50% and 10% is 0.6, 1.9 and 1.6, respectively.
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