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EC number: 200-718-6 | CAS number: 69-89-6
- 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
Endpoint summary
Administrative data
Description of key information
Skin: OECD Guideline 429; mouse. Not a sensitizer. Reliability = 1
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The test item solubility was tested in acetonitrile, water, 1: 1 (v:v) acetonitrile:water, isopropanol, methanol, ethanol, 1,4-butandiol, N,N-dimethylformamide (DMF) and tertbutanol at 100 mM. The test item was not soluble in any of these solvents. Therefore, in vitro studies could not be performed.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- Purity: > 99%
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS Inc.
- Age at study initiation: Preliminary Animals: Young adult (11 weeks); Test and Control Animals: nulliparous and non-pregnant; young adult (11 or 12 weeks)
- Weight at study initiation: 19.9- 24.8 grams
- Housing: Individually housed in plastic solid bottom cages during dosing and resting phase of study; after final weighing until sacrifice, animals housed in respective dose groups in plastic cages with bedding.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 28 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Humidity (%): 67-79% (Humidity was above the targeted upper limit for 4 days during the study. A portable dehumidifier was used to lower the humidity levels during this time. This excursion was considered minor and had no impact on this study.)
- Air changes (per hr): 12
- Photoperiod (hrs dark/ hrs light): 12-hour light/dark cycle
- Vehicle:
- other: 1% Pluronic L92
- Concentration:
- 10, 25, 50%
- No. of animals per dose:
- 5 females
- Details on study design:
- PRE-SCREEN TESTS:
- Dosing: 10%, 25%, and 50% w/w mixtures in 1% Pluronic® L92; 25 µL concentration of test substance or vehicle alone applied to dorsum of both ears of each mouse for three consecutive days; dose spread evenly as possible over dorsal surface of ear using tip of pipette; no treatment made on Days 4 and 5; on Day 6, sites for each mouse evaluated for local reactions (erythema & edema); animals were observed daily for signs of toxicity. Data from pre-screen used to select the three concentrations to be tested in main study.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: If test substance produces an SI ≥ 3, it is considered "positive" for dermal sensitization potential.
TREATMENT PREPARATION AND ADMINISTRATION: Beginning on Day 1, a quantity of 25 µL of test substance concentration, positive control substance, or vehicle alone applied to dorsum of both ears of each mouse once per day for three consecutive days (Days 1, 2, and 3) using a micropipette. During application, material was spread evenly as possible over dorsal surface of ear using tip of pipette. On Day 6 of study (three days after the final topical application), 250 µL of sterile phosphate buffered saline (PBS) containing 20 µCi of 3H-methyl thymidine was injected intravenously via tail vein of each mouse. Approximately five hours after injections, all test and control mice were euthanized and draining auricular lymph nodes were excised.
TEST SYSTEM/ASSESSMENT: Lymph nodes evaluated for each individual mouse. A single cell suspension of lymph node cells (LNC) prepared in PBS by gently massaging lymph nodes between frosted ends of microscope slides over collection vessel. The slides were then rinsed briefly with PBS into vessel. Contents of vessel transferred to centrifuge tube and washed with excess of PBS and centrifuged- process carried out twice. In both cases, supernatant decanted and discarded following each centrifugation. After second wash, 5 mL of 5% trichloroacetic acid (TCA) in distilled water added to sediment and tube vortexed. DNA was precipitated in 5% TCA in distilled water at 4°C overnight (approximately 18 hours). Following the overnight precipitation of DNA, tubes centrifuged again and supernatant discarded. Resulting precipitate re-suspended using 1 mL of 5% TCA in distilled water and transferred to 10 mL of scintillation fluid. Incorporation of 3 H-methyl thymidine was measured by beta-scintillation counting and expressed as disintegrations per minute, minus background dpm.
All mice were observed for signs of mortality, gross toxicity, and/or behavorial changes daily. Individual body weight were recorded on Day 1 (initial) shortly before test substance application and prior to IV injections on test Day 6. - Positive control substance(s):
- other:
- Statistics:
- Statistical analysis was performed on DPM minus background values. Significance was judged at p < 0.05. Treated groups and negative vehicle control group compared using a OneWay Analysis of Variance (ANOVA), followed by comparison of treated groups to control by Dunnett's t-test for multiple comparisons. Where variances were considered significantly different by Bartlett's test, groups were compared using a non-parametric method (Kruskal-Wallis non parametric analysis of variance followed by Dunn's test).
- Positive control results:
- The positive control (HCA) at 25% produced a dermal sensitization response in mice (SI = 7.96).
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 10%
- Remarks on result:
- other: test substance was not considered positive for a dermal sensitization potential
- Key result
- Parameter:
- SI
- Value:
- 1.43
- Test group / Remarks:
- 25%
- Remarks on result:
- other: test substance was not considered positive for a dermal sensitization potential
- Key result
- Parameter:
- SI
- Value:
- 1.56
- Test group / Remarks:
- 50%
- Remarks on result:
- other: test substance was not considered positive for a dermal sensitization potential
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA: None
DETAILS ON STIMULATION INDEX CALCULATION: Stimulation Index = Average dpm of Test Substance/Average dpm of Vehicle.
EC3 VALUE: Not calculated since all dose levels induced a stimulation index (SI) of less than 3.0.
CLINICAL OBSERVATIONS: All animals appeared active and healthy throughout study.
BODY WEIGHTS: Six mice from test and two from positive control groups lost body weight during study. All other mice gained body weight during study.
SIGNS OF TOXICITY (including dermal irritation at the site of administration, if any, e.g. increased ear thickness). None - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not considered to be a contact dermal sensitizer at concentrations less than or equal to 50% in the LLNA.
- Executive summary:
A dermal sensitization test was conducted with mice to determine the potential for the test substance to produce sensitization after repeated topical applications. Three concentrations of the test substance (10%, 25% and 50%) w/w in distilled water (1% Pluronic® L92) were topically applied to fifteen healthy test mice (five mice/group) for three consecutive days. Three days after the last application, the mice were given an IV injection containing 20 µCi of 3H-methyl thymidine. Approximately five hours later, all animals were euthanized via an overdose of inhaled lsoflurane and the draining (auricular) lymph nodes were harvested and prepared for analysis in a scintillation counter. During the study, each animal's ears were evaluated for erythema and edema prior to each application and again on Day 6, prior to the IV injection. A vehicle control group (five animals) and a positive control group (five animals) were maintained under the same environmental conditions and treated in the same manner as the test animals. The vehicle control animals were treated with 1% Pluronic® L92 and the positive control group animals were treated with a 25% w/w mixture of HCA in 1% Pluronic® L92. In an effort to reduce the total number of animals used, this study was run concurrently with another study to utilize a common positive control and common vehicle control group. All animals appeared active and healthy throughout the study. Six mice from the test and two from the positive control groups lost body weight during the study. All other mice gained body weight during the study. Mean DPM (minus bsckground) scores were 1196.43, 9520.82, 1200.49, 1710.02, and 1867.91 for the vehicle control, positive control, 10%, 25% and 50% test substance groups, respectively. Simulation index was not calculated, 7.96, 1.00, 1.43, 1.56, respectively. Based on the results of the study, the test substance is not considered to be a contact dermal sensitizer at concentrations less than or equal to 50% in the LLNA. Proper conduct of the LLNA was confirmed via a positive response with 25% HCA, a moderate contact sensitizer.
Reference
As a stimulation index (SI) of less than 3.0 was observed in all the treatment groups, the test substance was not considered positive for a dermal sensitization potential. The positive control (HCA) at 25% produced a dermal sensitization response in mice (SI = 7.96). Therefore, the LLNA test system was valid for this study.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
The test substance was negative for sensitization in a local lymph node assay in mice. Therefore, the substance dose not need to be classified for skin sensitization according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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