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Diss Factsheets
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EC number: 500-320-5 | CAS number: 130353-58-1
- 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:
- 03 Apr - 04 May 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted in 2010
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 921-836-0
- EC Number:
- 921-836-0
- IUPAC Name:
- 921-836-0
- Details on test material:
- - Name of test material (as cited in study report): [trade name]
- Physical state/appearance: dark yellow liquid
- Analytical purity: no data
- Batch No.: 103991
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: 8-9 weeks
- Housing: 5 per cage in IVC cages, type II L
- Diet: Altromin 1324 maintenance diet for rats and mice; ad libitum
- Water: tap water (sulphur acidified to a pH value of approx. 2.8); ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/ 12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50 and 100%
- No. of animals per dose:
- - Main test: 5
- Pre-test: 3 - Details on study design:
- RANGE FINDING TESTS:
2 animals were treated by topical application with the undiluted test substance on three consecutive days. 1 animal was treated with AOO (negative control).
- Compound solubility: The maximum technically applicable concentration of the test item was found to be 100% in AOO.
- Irritation: Both ears of each animal were observed daily for erythema and edema as well as for ear thickness before the first application and approx. 48 hours after the first application and before sacrifice (day 6).
- Lymph node proliferation response: not examined
Neither signs of systemic toxicity nor signs of irritation at the application site could be detected in any animal.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: A substance is considered a sensitiser in the LLNA if at least one concentration of the test substance results in a 3-fold or greater increase in ³H-methyl thymidine incorporation into lymph node cells of the test group animals, relative to that recorded for the lymph nodes of control group animals (SI >= 3).
TREATMENT PREPARATION AND ADMINISTRATION:
- Topical application: Each mouse was treated by topical application of 25 µL of the 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 all mice were dosed with 20 µCi ³H-methyl thymidine by intravenous injections of 250 µL of ³H-methyl thymidine, diluted to a working concentration of 80 µCi/mL.
- Preparation of cell suspension:
Approx. 5 hours after the injection of ³H-methyl thymidine all mice were sacrificed by cervical dislocation. Draining auricular lymph nodes were excised, individually pooled for each animal (2 lymph nodes per animal) and collected in PBS. A single cell suspension of pooled lymph node cells was prepared by gentle mechanical disaggregation through polyamide gauze. 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. The washing procedure was repeated.
After the final wash each pellet was resuspended in 5% TCA at 4 °C for approx. 18 hours. Each precipitate was washed again, resuspended in 5% TCA and scintillation fluid was added. The solution was transferred into scintillation vials and stored at room temperature overnight.
- Determination of incorporated ³H-methyl thymidine: The incorporation was measured in a beta counter and expressed as the number of disintegrations per minute (DPM). Determination of radioactivity was performed individually for each animal. - Positive control substance(s):
- other: P-Phenylenediamine (in a separate study)
Results and discussion
- Positive control results:
- Stimulation index (mean value out of 5 animals treated with phenylene diamine): 10.9 ± 3.3
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Mean DPM values (out of 5 animals, respectively) ± SD: - Negative control: 1897.6 ± 302.2 - 25%: 2948.2 ± 801.5 - 50%: 3243.6 ± 1639.1 - 100%: 4198.2 ± 1213.2
- Key result
- Parameter:
- SI
- Remarks:
- mean value out of 5 animals
- Value:
- 1.6
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Remarks:
- mean value out of 5 animals
- Value:
- 1.7
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Remarks:
- mean value out of 5 animals
- Value:
- 2.2
- Test group / Remarks:
- 100%
Any other information on results incl. tables
All animals survived throughout the test period without showing any clinical signs. All animals showed the expected weight development.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation(EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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