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EC number: 945-527-5 | CAS number: -
- 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
- Study period:
- 26.04.2013 to 17.07.2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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:
- Reaction products of Glycerin formal and 2-Propenoic acid, 2-methyl-, methyl ester
- EC Number:
- 945-527-5
- Cas Number:
- 1620329-57-8
- Molecular formula:
- C8H12O4
- IUPAC Name:
- Reaction products of Glycerin formal and 2-Propenoic acid, 2-methyl-, methyl ester
- Test material form:
- liquid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: Mice, CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- Test system: Mice, CBA/CaOlaHsd
Rationale: Recognised as the recommended test system.
Source: Harlan Laboratories B.V., Postbus 6174, 5960 AD Horst / The Netherlands
Number of animals for the pre-test: 2 females
Number of animals for the main study: 20 females
Number of animals per group: 5 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) groups: 1
Age: Pre-test: 9 - 10 weeks (beginning of treatment)
Main study: 11 - 12 weeks (beginning of treatment)
Body weight: 20.1-23.2 g, Mean SD: 21.7 +/- 0.9 g
Identification: The animals were distributed into the test groups at random. All animals belonging to the same experimental group were kept in one cage.experiment. In the main experiment the animals were identified by tail tags. In the pre-experiment, animals were identified by cage
number.
Acclimation: 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.
The animals were kept conventionally. The experiment was conducted under standard laboratory conditions.
Housing: group
Cage Type: Makrolon Type II (pre-test) / III (main study), with wire mesh top
Bedding: granulated soft wood bedding
Feed: 2018C Teklad Global 18% protein rodent diet (certified), ad libitum
Water: tap water, ad libitum
Environment: temperature 22 + 2°C
relative humidity approx. 45-65%
artificial light 6.00 a.m. - 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25, 50 and 100 %
- No. of animals per dose:
- Number of animals for the pre-test: 2 females
Number of animals for the main study: 20 females
Number of animals per group: 5 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) groups: 1 - Details on study design:
- Topical application
Each test group of mice was treated by (epidermal) topical application to the dorsal surface of each ear with test item concentrations of 25, 50, and 100% in acetone/olive oil (4+1, v/v). The application volume, 25 μL/ear/day, was spread over the entire dorsal surface (∅ ∼ 8 mm) of each ear once daily for three consecutive days. A further group of mice (control animals) was treated with an equivalent volume of the relevant vehicle alone (control animals).
Administration of 3H-methyl-thymidine
Five days after the first topical application (day 6) 250 μL of phosphate-buffered saline containing 20.1 μCi of 3H-methyl thymidine (equivalent to 80.3 μCi/mL 3HTdR) were injected into each test and control mouse via the tail vein.
Determination of incorporated 3HTdR
Approximately five hours after treatment with 3HTdR all mice were euthanised by using CO2, which was, after harvesting of the lymph nodes, followed by cervical dislocation to ensure death.
The draining lymph nodes were rapidly excised and pooled per animal (2 nodes per animal).
Single cell suspensions (in phosphate buffered saline) of pooled lymph node cells were prepared by gentle mechanical disaggregation through stainless steel gauze (200 μm mesh size). After washing two times with phosphate buffered saline (approx. 10 mL) the lymph node cells were resuspended in 5 % trichloroacetic acid (approx. 3 mL) and incubated at approximately +4 °C for at least 18 hours for precipitation of macromolecules. The precipitates were then resuspended in 5 % trichloroacetic acid (1 mL) and transferred to scintillation vials with 10 mL of scintillation liquid and thoroughly mixed. The level of 3HTdR incorporation was then measured in a β-scintillation counter. Similarly, background 3HTdR levels were also measured in two 1 mL aliquots of 5 % trichloroacetic acid. The β-scintillation counter expresses 3HTdR incorporation as
the number of radioactive disintegrations per minute.
Observations
In addition to the sensitising reactions the following observations and data were recorded during the test and observation period:
Mortality / Viability: At least once daily from experimental start to necropsy.
Body weights: In the pre-test: prior to the first application and prior to sacrifice. In the main experiment: prior to the first application and prior to treatment with 3HTdR.
Ear thickness: In the pre-test prior to the first application of the test item (day 1), on day 3 and before sacrifice (day 6).
Ear weights: In the pre-test after sacrifice; biopsy punches were taken from each ear.
Clinical signs (local / systemic): Clinical signs (local irritation at the application site or systemic toxicity) were recorded at least once daily.
Especially the treatment sites were observed carefully. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated in the body weight tables and for the DPM values (group mean DPM ± standard deviation).
The Dean-Dixon-Test was used for identification of possible outliers (performed with Microsoft Excel 2007).
However, both biological and statistical significance were considered together.
Results and discussion
- Positive control results:
- see: any other information on material and methods
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- control
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- 25 % Glycerolformal methacrylate
- Remarks on result:
- other: negative
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- 50 % Glycerolformal methacrylate
- Remarks on result:
- other: negative
- Parameter:
- SI
- Value:
- 1.2
- Test group / Remarks:
- 100 % Glycerolformal methacrylate
- Remarks on result:
- other: negative
Any other information on results incl. tables
Results
Calculation and Results of Individual Data
Vehicle: acetone/olive oil (4+1, v/v)
Test itemconcentration |
DPMvaluesmeasured |
DPM-BG peranimal(2 lymph nodes)a) |
S.I.b) |
||
% |
Groupno. |
Animalno. |
|||
--- |
--- |
BG I |
22 |
--- |
--- |
--- |
--- |
BG II |
20 |
--- |
--- |
0 |
1 |
1 |
280 |
259.0 |
--- |
0 |
1 |
2 |
333 |
312.0 |
--- |
0 |
1 |
3 |
431 |
410.0 |
--- |
0 |
1 |
4 |
240 |
219.0 |
--- |
0 |
1 |
5 |
368 |
347.0 |
--- |
25 |
2 |
6 |
362 |
341.0 |
1.1 |
25 |
2 |
7 |
152 |
131.0 |
0.4 |
25 |
2 |
8 |
271 |
250.0 |
0.8 |
25 |
2 |
9 |
239 |
218.0 |
0.7 |
25 |
2 |
10 |
434 |
413.0 |
1.3 |
50 |
3 |
11 |
218 |
197.0 |
0.6 |
50 |
3 |
12 |
150 |
129.0 |
0.4 |
50 |
3 |
13 |
343 |
322.0 |
1.0 |
50 |
3 |
14 |
268 |
247.0 |
0.8 |
50 |
3 |
15 |
394 |
373.0 |
1.2 |
100 |
4 |
16 |
385 |
364.0 |
1.2 |
100 |
4 |
17 |
406 |
385.0 |
1.2 |
100 |
4 |
18 |
728 |
707.0 |
2.3 |
100 |
4 |
19 |
169 |
148.0 |
0.5 |
100 |
4 |
20 |
325 |
304.0 |
1.0 |
1 = Control Group
2-4 = Test Group
a)= values corrected for mean background value (BGI and BGII)
b)= Stimulation Indices relative to the mean of the control group (Group 1)
Calculation of Stimulation Indices per Dose Group
Test itemconcentration |
Group Calculation |
||
Mean DPMperanimal (2lymphnodes)a) |
SD |
S.I. |
|
Vehicle ControlGroup (acetone/olive oil (4+1,v/v)) |
309.4 |
74.6 |
1.0 |
25%Glycerinformalmethacrylate |
270.6 |
109.4 |
0.9 |
50%Glycerinformalmethacrylate |
253.6 |
97.1 |
0.8 |
100%Glycerinformalmethacrylate |
381.6 |
204.2 |
1.2 |
The EC3 value could not be calculated, since all S.I.´s are below the threshold value of 3.
Applicant's summary and conclusion
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- The test item Glycerinformal methacrylate was not a skin sensitiser under the test conditions of this study.
- Executive summary:
In an OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay) Glycerolformal methacrylate was testet at concentrations of 25, 50 and 100 % in acetone/olive oil (4:1 v/v).
Stimulation Indices of 0.9, 0.8 and 1.2 were determined with the test item at concentrations of 25, 50, and 100%. A dose response was not observed.
The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3.
In conclusion Glycerinformal methacrylate was not a skin sensitiser under the test conditions of this study.
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