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Diss Factsheets
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EC number: 460-100-9 | CAS number: 342573-75-5
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (429)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- -temperary fluctuations of relative humidity above level of 70%. Based on laboratory historical data, these fluctuations were considered not to have affected the study integrity
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Details on test material:
- Physical apprearance: Light yellow viscous liquid
- Batch: 99/484
- Storage: RT in the dark
- Stability under in vehicle (Dimethyl foramamide): at least 96 h
- Specific gravity: 1.23
- Purity: 99% (HPLC)
- Epiry date: 2005 (allocated by NOTOX, 1 year after receipt of the test substance)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA strain, inbred, SPF-Quality
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: Charles River France, L'Arbresle Cedex, France
- Age at study initiation: approx 10 wks
- Weight at study initiation: +/- 20% of the sex mean
- Housing: individually
- Diet : standard pelleted laboratory animal diet (code VRF 1, Altromin, Lage, Germany)
- Water: Free access to tap-water
- Acclimation period: =>5 days
- Preparation of test formulations: the test substance formulations (wlw) were prepared within 4 hours prior to each treatment.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4 - 21.9
- Humidity (%): 41 - 75
- Air changes (per hr): approx. 15
- Photoperiod (hrs dark / hrs light): 12
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Remarks:
- (selected based on trial formulations performed at NOTOX)
- Concentration:
- 25%, 50% in vehicle and 100% (undiluted)
- No. of animals per dose:
- 5 females
- Details on study design:
- RANGE FINDING TESTS:
- Concentrations: 50%, 100% (undiluted)
- # of animals: 1 per dose (total of 2)
- Age of animals: 5-14 weeks old
- Duration of treatment: Each animal was treated with one concentration on three consecutive days. Approximately 4 hours after the last exposure, the ear was cleaned of residual test substance with water and the irritation was assessed.
- Procedure: Identical to those used during days 1 to 3 of the main study unless where specified. Bodyweights were determined on day 3. No necropsy was performed after termination.
MAIN STUDY
INDUCTION
- Frequency of application: once daily for 3 days (days 1, 2 and 3)
- Site of application: ears
- Route of application: epidermal
- Volume applied: 25 µl/ear
- Concentrations: 25%, 50% in vehicle and 100% (undiluted)
INJECTION OF 3H-methyl thymidine
- Day of injection: 3 days after last treatment (day 6)
- Site of injection: tail vein
- Vehicle: PBS
- Volume injected: 0.25 ml
- Specific radioactivity: 20 µCi/injection
SACRIFICE
- Time schedule: 5 hours after injection of 3H-methyl thymidine
- Method: injection of phenobarbital
TISSUE PROCESSING AND MEASUREMENTS
- Lymph node processed: auricular lymph nodes
- Pooling of lymph nodes: yes
- Measurement of radioactivity: Packard scintillation counter (1900TR) (Counting time was to a statistical precision of ± 0.2% or a maximum of 5 minutes whichever comes first)
CRITERIA FOR POSTIVE RESULT
The stimulation index (SI) is the ratio of the disintergrations per minute (DPM) per group compared to DPM/vehicle control group. If the results indicate a stimulation index (SI) greater or equal to 3, the test substance may be regarded as a skin sensitiser, based on the test guideline and recommendations done by ICCVAM (NIH publication; No 99-4494, February 1999). If possible, an EC3 value (the estimated test substance concentration that will give a SI of 3 was determined, using linear interpolation.
OTHER
The test animals were checked twice daily for mortality/viability and at least once a day for toxicity signs. Bodyweight of the test animals was taken on day 1, prior to treatment and on days 6. On day 3 (3-4 hours after treatment), the skin reactions were assessed. If possible, skin reactions were graded following the draize numerical scoring system. Furthermore descriptions of all other (local) effects were recorded. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- other: Concentrations: 5, 10 and 25 % in acetone: olive oil (4:1)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: TEST GROUPS - control (dimethylformamide): 1 - 25 %: 1.1 - 50%: 1.0 - 100 %:0.7 POSITIVE CONTROL - control (acetone/olive oil): 1 - 5%: 1 - 10%: 3.2 - 25%: 7.1
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: TEST GROUP (Mean DPM/Animal) - Control (dimethylformamide): 373 - 25 %: 411 - 50%: 385 - 100 %: 243 POSITIVE CONTROL (DPM/animal) (see attachment 1) - control (acetone/olive oil): 241 ± 75 - 5%: 235 ± 53 - 10%: 766 ± 225 - 25%: 1708 ± 509
Any other information on results incl. tables
OBSERVATIONS (MAIN STUDY)
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study.
The majority of the nodes of the experimental and control groups were considered normal in size (visual inspection). The nodes of two animals treated at 25 and 100% were decreased in size. No other macroscopic abnormalities of the nodes were noted (see attachment # 1).
The simulation index was in the range of 0.7 to 1.1 % for all concentrations tested. Theris no indication that the substance could elicid an SI > 3. Based on the results the test substance should be regarded as not sensitizing..
RESULTS (RELIABILITY CHECK WITH POSITIVE CONTROL SUBSTANCE
The SI values calculated for the posive control at concentrations of 5, 10 and 25% were 1.0, 3.2 and 7.1 respectively. An EC3 value of 9.5% was calculated for the positive control using linear interpolation. The calculated EC3 value was found to be in the acceptable range of 2 and 20%. The results of the 6 monthly HCA reliability checks of the recent years were 8 .8, 5 .5, 7.3 and 10.3%. The study results are valid therefore.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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