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EC number: 611-591-5 | CAS number: 57903-73-8
- 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: GLP guidelien study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- [[2-[2-[2-(3-chloro-2-hydroxy-propoxy)propoxymethyl]-3-(2-prop-2-enoyloxypropoxy)-2-(2-prop-2-enoyloxypropoxymethyl)propoxy]-1-methyl-ethyl] prop-2-enoate
- EC Number:
- 611-591-5
- Cas Number:
- 57903-73-8
- Molecular formula:
- Not specified UVCB - Reaction product of 1-chloro-2,3- epoxypropane (0-9 mol) with pentaerythritol and acrylic acid.
- IUPAC Name:
- [[2-[2-[2-(3-chloro-2-hydroxy-propoxy)propoxymethyl]-3-(2-prop-2-enoyloxypropoxy)-2-(2-prop-2-enoyloxypropoxymethyl)propoxy]-1-methyl-ethyl] prop-2-enoate
- Details on test material:
- - Name of test material (as cited in study report): Pentaerythritol, olig. react. prod. with 1-chloro-2,3-epoxypropane, react. prod. with acrylic acid
- Physical state: liquid, viscous/yellowish
- Analytical purity: 100 %
- Lot/batch No.: Mischcharge aus G44/082/11 und G44/085/11
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: 8 weeks
- Housing: single housing (Makrolon gabe, type II)
- Diet (e.g. ad libitum): STANRAB (P) SQC; SDS Special Diets Services. 67122 Altrip, Germany
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 -70 %
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 5, 10 and 25%
- No. of animals per dose:
- 5
- Details on study design:
- Three groups each of five female mice were treated once daily with the test item at concentrations of 5, 10, and 25% (w/w) in N, N-dimethylformamide by topical application to the dorsum of each ear for three consecutive days.
The application volume 25 µL/ear/day was spread over the entire dorsal surface (Ø 8 mm) of each ear once daily for three consecutive days. The control test group of mice was treated with an equivalent volume of the relevant vehicle alone. The positive control test group of mice was treated with 25 % α-hexyl cinnamaldehyde dissolved in N, N-dimethylformamide.
Four days after the first topical application, the mice were intraperitoneally injected with BrdU. Approximately 24 hours after intraperitoneally injection, the mice were sacrificed and the draining auricular lymph nodes excised, pooled per animal and immediately weighed using an analytical balance. Furthermore, both ears of mice were punched at the apical area using a biopsy punch and the punches were immediately weighed pooled per animal using an analytical balance. Afterwards, single cell suspensions of lymph node cells were prepared from lymph nodes pooled per animal. An aliquot of each cell suspension was used for determination of lymph node cell count. The proliferative capacity of pooled lymph node cells was determined by the incorporation of BrdU measured in a photometer.
Results and discussion
Any other information on results incl. tables
A statistically significant increase in ear weights was observed in all doses groups, but was considered not to be biologically relevant. According to OECD guideline 442B, an increase in ear weight exceeding the threshold value of 25% was considered to be indicative for excessive local skin irritation. This threshold was not exceeded in any test item treated group.
In this study Stimulation Indices (S.I.) of 1.0, 1.1 and 1.9 were determined with the test item at concentrations of 5, 10 and 25 % (w/w) in N, N-dimethylformamide, respectively. Based on the S.I.s obtained with 10 and 25% test item concentration, an EC1.6 value of 19.38% (w/w) was calculated. A clear dose response was observed. A statistically significant and biologically relevant increase in BrdU labeling was observed for the high (25%) dose group. Also observed was a statistically significant increase in lymph node weights for the low (5%) and high (25%) dose group and in lymph node cell count for the mid (10%) and high (25%) dose group. Furthermore, the cut-off-value for a positive response regarding the lymph node cell count index of 1.55 reported for BALB/c mice (see Ref. 8) was exceeded in the high dose group.
Applicant's summary and conclusion
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.
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