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EC number: 500-322-6 | CAS number: 144086-03-3 1 - 6.5 moles ethoxylated
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (missing positive control)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- missing positive control treatment
- GLP compliance:
- no
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Glycerol, ethoxylated, esters with acrylic acid
- EC Number:
- 500-322-6
- EC Name:
- Glycerol, ethoxylated, esters with acrylic acid
- Cas Number:
- 144086-03-3
- Molecular formula:
- UVCB substance
- IUPAC Name:
- Glycerol, ethoxylated, esters with acrylic acid
- Details on test material:
- - Name of test material (as cited in study report): Glycerin3EOTA
- Lot/batch No.: GK0561/1128
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- no data
Study design: in vivo (non-LLNA)
- Details on study design:
- 1st application: Induction 1 % open epicutaneous
Study design: in vivo (LLNA)
- Vehicle:
- other: acetone
- Concentration:
- In the first step concentrations of 1, 3 and 10% of the test substance in acetone were used. As
Iymph fade reactions and increases in ear weight were produced by all concentrations, in the second step concentrations of 0.1, 0.3 and 1 % were examined in order to determine a concentration not inducing lymph node reactions. - No. of animals per dose:
- 6 females
- Details on study design:
- Each test animal was applied with 25 µl per ear of the respective test substance preparation to the dorsum of both ears tor three consecutive days. The control group was treated with 25 µl per ear of the vehicle alone.
Three days after the last application the mice were sacrificed and the auricular lymph nodes were removed. Lymph node response was evaluated by measuring the cellular content (indicator of cell proliferation) and weight of each animal's pooled Iymph nodes. Moreover, a defined area with a diameter of 0.8 cm was punched out of the apical part of each ear and tor each animal the weight of the pooled punches was determined in order to obtain an indication of possible skin Irritation. In addition the body weight change over the study period was determined. - Statistics:
- The statistical evaluations were performed using the WILCOXON-test ( # for p <= 0.05, ## for p <= 0.01).
Results and discussion
In vivo (LLNA)
Results
- Parameter:
- SI
- Remarks on result:
- other: EC1.5 (ear weight) >1% <3% EC1.5 (cell count) >0.3% <1%
Any other information on results incl. tables
Lymph Node Weight | |||
Treatment | mean (mg) | Index | Significance |
vehicle | 5.4 | 1.00 | |
vehicle | 5.1 | 1.00 | |
0.1% | 5.3 | 1.05 | |
0.3% | 5.9 | 1.17 | ## |
1% | 7 | 1.38 | # |
1% | 7.6 | 1.41 | ## |
3% | 10.5 | 1.95 | ## |
10% | 11.9 | 2.20 | ## |
Cell Count | |||
Treatment | mean (counts/lymph node pair) | Index | Significance |
vehicle | 9,790 | 1.00 | |
vehicle | 10,101 | 1.00 | |
0.1% | 10,805 | 1.07 | |
0.3% | 11,706 | 1.16 | |
1% | 15,351 | 1.52 | # |
1% | 17,096 | 1.75 | ## |
3% | 23,836 | 2.43 | ## |
10% | 32,162 | 3.29 | ## |
No signs of systemic toxicity were noticed. The test substance induced a statistically significant and biologically relevant proliferation of the auricular lymph nodes and cell counts when applied as 1, 3 and 10% test substance preparation in acetone to the ear of the mice. A statistically significant increase in lymph node weights but not in lymph node cellularity was observed at the test substance concentration of 0.3%. The increased ear weights (6 to 38% in the treatments 1 to 10%) and clinical signs of skin irritation (incrustation in 5 animals, scaling in 1 animal applied with the 10% test substance preparation and incrustation in 1 animal applied with the 3% test substance preparation) indicated a significant irritant property of the test substance at concentrations of 1%, 3% and 10%.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
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