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EC number: 811-451-5 | CAS number: 1802140-94-8
- 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, other
- Remarks:
- this in vivo study was already available before it became mandatory to first use in vitro studies to assess the sensitization potential
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From October 21, 2015 to October 27, 2015
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted with read across substance according to OECD Guideline 429 and EU Method B.42, in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with phosphorus oxide (P2O5)
- IUPAC Name:
- 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with phosphorus oxide (P2O5)
- Reference substance name:
- 1187441-10-6
- Cas Number:
- 1187441-10-6
- IUPAC Name:
- 1187441-10-6
- Test material form:
- other: Liquid
Constituent 1
Constituent 2
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 Laboratories S.r.l., San Pietro al Natisone (UD), Zona Industriale Azzida, 57, 33049 Italy.
- Age at study initiation: 11 weeks old.
- Weight at study initiation: 19.1 - 20.4 g.
- Housing/ Enrichment: Group caging / mice were provided with glass tunnel-tubes.
- Cage type: Type II polypropylene / polycarbonate.
- Bedding: Lignocel 3/4-S Hygienic animal bedding.
- Source for bedding: J. Rettenmaier & Söhne GmbH & Co.KG (Holzmühle 1, 73494 Rosenberg, Germany) .
- Diet: ad libitum.
- Supplier of diet: ssniff spezialdiäten GmbH (Ferdinand-Gabriel-Weg 16, D-59494 Soest, Germany).
- Water: ad libitum.
- Acclimation period: 21 d.
ENVIRONMENTAL CONDITIONS
- Temperature: 17.9 – 25.9°C
- Humidity: 30 - 87%
- Air changes: 15 - 20 air exchanges per h
- Photoperiod: 12 h daily, from 6.00 a.m. to 6.00 p.m.
The temperature and relative humidity were recorded twice every day during the acclimatisation and experimental phases
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Preliminary test- 25 and 50% in DMF
Main test- 0, 10, 25 and 50% in DMF - No. of animals per dose:
- Preliminary test- 2 animals/dose
Main test- 4 animals/dose - Details on study design:
- PRELIMINARY STUDY
A preliminary study was performed with the test substance concentrations 25 and 50% (w/v) in DMF. It was conducted in a similar experimental manner to the main study, but terminated on Day 6 with a body weight measurement and the radioactive proliferation assay was not performed. All mice were observed daily for any clinical signs of systemic toxicity or local irritation at the application site. Both ears of each mouse were observed for erythema and scored. Ear thickness was also measured using a thickness gauge on Day 1 (pre-dose), Day 3 (approximately 48 h after the first dose) and Day 6. Additional quantification of the ear thickness was performed by ear punch weight determination after the euthanasia of the experimental animals.
MAIN STUDY
Based on results in preliminary test, 50% (w/v) dose was selected as top dose for the main test. The experimental groups and dose levels for the main experiment were:
1. Negative (vehicle) control (DMF)
2. 10% of test substance
3. 25% of test substance
4. 50% of test substance
5. Positive control (25% alpha-Hexylcinnamaldehyde solution in DMF)
Topical application: 25 µL of the appropriate formulation was applied using a pipette on the dorsal surface of each ear on Day 1, 2 and 3. No treatment was given on Day 4, 5 and 6.
Injection of tritiated Thymidine (3HTdR): On Day 6, animals were taken to the radioactive suite and each mouse was intravenously injected via the tail vein with 250 µL of sterile PBS (phosphate buffered saline) containing approximately 20 µCi of 3HTdR using a gauge 25G x 1" hypodermic needle with 1 mL sterile syringe. Once injected, the mice were left for 5h (±30 min).
Removal and Preparation of Draining Auricular Lymph Nodes: 5h (±30 min) after intravenous injection the mice were euthanized by asphyxiation with ascending doses of carbon dioxide (deep anaesthesia was confirmed before making incision, death was confirmed before discarding carcasses). The draining auricular lymph nodes were excised by making a small incision on the skin between the jaw and sternum, pulling the skin gently back towards the ears and exposing the lymph nodes. The nodes were then removed using forceps. The carcasses were discarded after cervical dislocation or after cutting through major cervical blood vessels. Once removed, the nodes of mice from each test group was pooled and collected in separate petri dishes containing a small amount (1 - 2 mL) of PBS to keep the nodes wet before processing.
Preparation of single cell suspension of lymph node cells: A single cell suspension (SCS) of pooled lymph node cells (LNCs) was prepared and collected in disposable tubes by gentle mechanical disaggregating of the lymph nodes through a cell strainer using the plunger of a disposable syringe. The cell strainer was washed with PBS (up to 10 mL). Pooled LNCs were pelleted with a relative centrifugal force (RCF) of 190 x g (approximately) for 10 min at 4ºC. After centrifugation supernatants were discarded. Pellets were gently resuspended and 10 mL of PBS was added to the tubes. The washing step was repeated twice. This procedure was repeated for each group of pooled lymph nodes
Determination of incorporated 3HTdR: After the final washing step, supernatants were removed. Pellets were gently agitated resuspended and 3 mL of 5% (w/v) TCA solution was added to the tubes for precipitation of macromolecules. After overnight (approximately 18 h) incubation at 2 - 8ºC, precipitates were centrifuged (approximately 190 x g for 10 min at 4ºC), and supernatants were removed. Pellets were resuspended in 1 mL of 5% (w/v) TCA solution and dispersed by using an ultrasonic bath. Samples were transferred into a suitable sized scintillation vial filled with 10 mL of scintillation liquid and thoroughly mixed. The vials were loaded into a β-scintillation counter and 3HTdR incorporation was measured (10 min measurement). The β-counter expresses the 3HTdR incorporation as the number of radioactive disintegrations per min (DPM). Background level was also measured in duplicates by adding 1 mL of 5% (w/v) TCA solution into a scintillation vial filled with 10 mL of scintillation liquid. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- A significant lymphoproliferative response (stimulation index value of 7.3) was noted for the positive control chemical, this result confirmed the validity of the assay.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The stimulation index values were 1, 1.6, 2.8 and 3.7 at concentrations of 0, 10, 25 and 50% (w/v), respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM for the experimental groups treated with test substance concentrations 10, 25 and 50% were 3,015, 5,094 and 6,699, respectively. The mean DPM for the vehicle control group was 1,830 and for positive control was 13,377.
Any other information on results incl. tables
No mortality or signs of systemic toxicity were observed. Slightly rigid ears were observed in the 50% (w/v) dose group on Day 4. No marked body weight loss (>5%) was detected on the mean body weight values of the groups; however one animal showed significant loss of body weight (5.1%) in the 50% (w/v) dose group.
MAIN TEST:
Clinical observation: No mortality or signs of systemic toxicity were observed during the study.
Body weight measurement: No treatment related effects were observed on the body weight changes of the experimental animals.
Table1: DPM, DPN and Stimulation Index values for all groups
Test Group Name |
Measured DPM / group |
DPM (Disintegration per minute) |
Number |
DPN (DPM/No. of lymph nodes) |
Stimulation Index |
Background |
36 |
- |
- |
- |
- |
(5% (w/v) TCA) |
32 |
||||
Negative (vehicle) control (DMF) |
1864 |
1830.0 |
8 |
228.8 |
1.0 |
50% (w/v) in DMF |
6733 |
6699.0 |
8 |
837.4 |
3.7 |
25% (w/v) in DMF |
5128 |
5094.0 |
8 |
636.8 |
2.8 |
10% (w/v) in DMF |
3049 |
3015.0 |
8 |
376.9 |
1.6 |
Positive control (25% (w/v) HCA |
13377 |
13343.0 |
8 |
1667.9 |
7.3 |
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the study conditions, the substance was shown to have sensitisation potential (sensitizer) in the local lymph node assay.
- Executive summary:
The skin sensitization potential of the read across substance (2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with phosphorus oxide (P2O5)) was evaluated in a mouse local lymph node assay, conducted according to OECD Guideline 429 and EU Method B42, in compliance with GLP. Test substance concentrations selected for the main study were based on the results of a preliminary irritation test. In the main study, animals were treated topically with 10, 25 and 50% w/v of test substance on Days 1, 2 and 3. Negative control animals were similarly treated with vehicle alone (N,N-dimethylformamide (DMF)) and positive control animals received 25% alpha-hexylcinnamaldehyde. On Day 6, tritiated thymidine (3HTdR) was injected intravenously. 5h (±30 min) after intravenous injection, the mice were euthanized by asphyxiation and draining auricular lymph nodes were excised. A single cell suspension of lymph node cells was prepared. 3HTdR incorporation was measured by β-scintillation counter. The activity was expressed as the number of disintegrations per minute (DPM) and a stimulation index (SI) was subsequently calculated for each group.The EC3 value of the test substance (EC3 means the effective chemical concentration required for SI=3) was calculated by linear interpolation.No mortality or signs of systemic toxicity were observed during the study. No treatment related effects were observed on the body weight changes of the experimental animals. DPM for the experimental groups treated with test substance concentrations of 10, 25 and 50% were 3,015, 5,094 and 6,699, respectively. The DPM values observed for the vehicle and positive control substance in this experiment were within the general historical control range. The SI values determined were 1.6, 2.8 and 3.7 at concentrations of 10, 25 and 50% (w/v), respectively. These results show that the test substance at 50% concentration elicits a SI ≥3. The calculated EC3 value of the test substance was 30.6% (w/v). Under the study conditions, the substance was shown to have sensitisation potential in the local lymph node assay (Váliczkó É, 2015).
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