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EC number: 931-227-1 | CAS number: 28497-59-8
- 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
Endpoint summary
Administrative data
Description of key information
LLNA (OECD 429, GLP): not sensitizing (Envigo 2017)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10.08.2016 - 21.12.2016
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted 22. July 2010
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- Batch No. : 20104-24D
Reactiveester content: 96.07 %
Diester content (isomer mix): 86.4%
Triester content. 1.9 %
Methacrylic acid: 0.86%
Expiry Date: 15 January 2017
Storage Conditions: At room temperature - Species:
- mouse
- Strain:
- other: Mice, CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- CBA/CaOlaHsd mice, nulliparous, non-pregnant
- Age at study initiation (pre-test and main study): 9 - 10 weeks (beginning of treatment)
- Weight at study initiation (main test): 17.8 - 21.1 g
- Housing: single; Makrolon Type II (pre-test)/ III (main study, with wire mesh top
- Bedding: granulated soft wood bedding
- Diet (e.g. ad libitum):2018C Teklad Global 18% protein rodent diet (certified), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days prior to start of dosing
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 2°C
- Humidity (%): 45-65% (except for deviations)
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 1 (Control ) 0
2 (Low Dose) 0.5 % (w/v)
3 (Mid Dose) 2.5 % (w/v)
4 (High Dose) 5 % (w/v) - No. of animals per dose:
- Main study: 5 females (nulliparous and non-pregnant)
3 Pre-tests: 2 females (each) - Details on study design:
- To determine the highest non-irritant test concentration that at the same time did not induce signs of systemic toxicity, a pre-test was performed in two animals and stated in raw data and report. Two mice were treated by (epidermal) topical application to the dorsal surface of each ear with test item concentrations of 50 and 100% once daily each on three consecutive days. Prior to the first application of the test item and before sacrifice the body weight was determined. Clinical signs were recorded at least once daily. Eventual signs of local irritation were documented and a score was used to grade a possible erythema of the ear skin. Furthermore, prior to the first application of the test item (day 1), on day 3 and before sacrifice (day 6) the ear thickness was determined using a micrometer. Additionally, for both animals, the ears were punched after sacrifice (day 6) at the apical area using a biopsy punch (Ø 8 mm corresponding to 0.5 cm2) and were immediately pooled per animal and weighed using an analytical balance. Eventual ear irritation was considered to be excessive if an erythema of the ear skin of a score value ≥3 was observed at any observation time and/or if an increase in ear thickness of ≥25% was recorded on day 3 or day 6.
At the tested concentrations the animals showed an erythema of the ear skin (Score 3) and a decrase of body weight >5% from day 1 to day 3. Furthermore, the animal treated with 50% of the test item showed beginning eschar formation.
Therefore, the animals were sacrificed and a second pre-test performed with concentration of 10 and 25% was performed. At these concenrations, the animals showed an erythema of the ear skin (Score 1 to 2), slight erythema of scalp and slight eschar formation.The animal treated with 25% of the test item showed visible swelling of the ears and a transient decrease in body weight. Furthermore, for the animal treated with 25%, an increase of ear thickness and ear weight above the recommended threshold was also observed.
Therefore, a third pre-test was performed using concentrations of 2.5 and 5%. Both animals showed an erythema of the ear skin (Score 1 to 2) as well as scaly ears and slight eschar formation on day 6. Additionally, the animal treated with 5% test item concentration showed slight erythema of the scalp and increased spontaneous activity.
Despite the signs of irritation observed in the pre-test, the main study was performed at test item concentrations of 0.5, 1, 2.5, and 5 to cover as far as possible the concentration range in which the substance is used in practice.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response:
TREATMENT PREPARATION AND ADMINISTRATION: - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Within the program the Dean-Dixon-Test and Grubb’s Test were used for identification of possible outliers. An outlier (DPM value determined for animal 8) was detected in the Dean Dixon Test, but not in the Grubb’s Test, and was therefore not excluded from calculations.
- Positive control results:
- A positive control performed with alpha-Hexylcinnamaldehyd in October 2013 resulted in an S.I. of 1.8 at 5% (w/v)
alpha-Hexylcinnamaldehyd in acetone/olive oil (4+1, v/v), 3.2 at 10 % and 5.8 at 25 %. An EC3 of 9.3 % (w/v) was calculated. - Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Vehicle control
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 0.5 % Glycerol dimethacrylate
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 1.0 % Glycerol dimethacrylate
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 2.5 % Glycerol dimethacrylate
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- 5 % Glycerol dimethacrylate
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this vaild Local Lymph Node Assay according to OECD 429 Glycerol dimethacrylate was not a skin sensitizer.
CLP EU GHS (Regulation (EC) No 1272/2008) classification: not sensitizing - Executive summary:
In this vaild dermal sensitisation study according to OECD Guideline 429 (adopted July 2010) Glycerol dimethacrylate in acetone:olive oil (4+1, v/v), groups of 5 female CBA/CaOlaHsd mice were tested using the LLNA method with the individual approach.
In this Local Lymph Node Assay Glycerol dimethcrylate was not a sensitizer.
The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. From day 2 to 6 the animals treated with test item concentrations of 2.5 and 5% showed an erythema of the ear skin (Score 1), as well as scaly ears on test days 5 and 6. Animals treated with 0.5 and 1% test item concentrations did not show any signs of local skin irritation. In this study Stimulation Indices (S.I.) of 1.1, 1.1, 1.0, and 0.7 were determined with the test item at concentrations of 0.5, 1, 2.5, and 5% in acetone/olive oil (4+1, v/v), respectively.
CLP EU GHS (Regulation (EC) No 1272/2008) classification: not sensitizing
Reference
Calculation of Stimulation Indices per Dose Group
Test item concentration
|
Group calculation |
||
|
Mean DPM per animal (2 lymph nodes)a)
|
SD
|
S.I.
|
Vehicle Control Group (acetone/olive oil (4+1, v/v)) |
2554.1 |
1263.1 |
1.0 |
0.5% Glycerol dimethacrylate |
2808.5 |
1558.9 |
1.1 |
1% Glycerol dimethacrylate |
2705.7 |
964.5 |
1.1 |
2.5% Glycerol dimethacrylate |
2618.7 |
1672.6 |
1.0 |
5% Glycerol dimethacrylate |
1913.1 |
284.6 |
0.7 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In this vaild dermal sensitisation study according to OECD Guideline 429 (adopted July 2010) GDMA in acetone:olive oil (4+1, v/v), groups of 5 female CBA/CaOlaHsd mice were tested using the LLNA method with the individual approach.
The animals did not show any signs of systemic toxicity during the course of the study and no cases of mortality were observed. From day 2 to 6 the animals treated with test item concentrations of 2.5 and 5% showed an erythema of the ear skin (Score 1), as well as scaly ears on test days 5 and 6. Animals treated with 0.5 and 1% test item concentrations did not show any signs of local skin irritation. In this study Stimulation Indices (S.I.) of 1.1, 1.1, 1.0, and 0.7 were determined with the test item at concentrations of 0.5, 1, 2.5, and 5% in acetone/olive oil (4+1, v/v), respectively.
In this Local Lymph Node Assay GDMA was not a sensitizer.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on a reliable LLNA assay, GDMA is classified as not skin sensitizing according to Annex I of CLP/EU-GHS (1272/2008/EC) and UN-GHS.
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