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EC number: - | 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
Endpoint summary
Administrative data
Description of key information
LLNA (GLP and OECD 429 guideline study): not sensitising
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:
- from 29 March to 12 July 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- N° 2011/40
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: preliminary test: approx. 12 weeks old, Main study: 8 weeks old
- Weight at study initiation: 19.5 g (range 18.5 to 21.5g)
- Housing: by group of two (preliminary test) or four (main test) in polycarbonate cages (Tecniplast 1145T, 435 cm2) containing autoclaved sawdust (SICSA, Alfortville, France)
- Diet (e.g. ad libitum): free access to SSNIFF R/M-H pelleted maintenance diet, batch No. 5776558, (SSNIFF Spezialdiäten GmbH, Soest, Germany)
- Water (e.g. ad libitum): tap water (filtered using a 0.22 micron filter), ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From 25 to 30 April 2012 - Vehicle:
- dimethylformamide
- Remarks:
- batch No. BCBF9893V (Sigma)
- Concentration:
- Preliminary study: 10; 25; 50 and 100 %
Main study: 0; 5; 10; 25; 50 and 100 % - No. of animals per dose:
- Preliminary study: 2
Main study: 4 - Details on study design:
- RANGE FINDING TESTS:
- Compound solubility:The first choice vehicle was a mixture of Acetone/Olive oil 4/1; v/v)(AOO). As unsatisfactory solubility of the test item was obtained in AOO (i.e. heterogeneous emulsion or suspension to the naked eye at the concentration of 50% was obtained), dimethylformamide (DMF) was used. A solution was obtained at the concentration of 50% in DMF.
- Irritation: Measurement of the ear thickness and observation of local reactions. No local reactions were observed in any animals up to the highest concentration (100%). The percentage of ear thickness increase compared to day 1 was less than 10% in all animals and at all concentrations. Therefore the test item is considered as non-irritant.
- Lymph node proliferation response: not examined
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: the animals were allocated to the groups using a manual randomization procedure. A larger number of animals than necessary was acclimated to permit the selection and/or replacement of individuals. The animals were individually identified on the tail using an indelible marker (unique CIT identity number).
- Criteria used to consider a positive response: the test item is considered as a skin sensitizer when the SI for a dose group is >= 3 together with consideration of a dose-response relationship. Other relevant criteria such as radioactivity levels and ear thickness are also taken into account to evaluate the data.
TREATMENT PREPARATION AND ADMINISTRATION: On days 1, 2 and 3, a dose-volume of 25 µL of the control or dose formulation preparations was applied to the dorsal surface of both ears, using an adjustable pipette fitted with a plastic tip.
In order to avoid licking and to ensure an optimized application of the test materials, the animals were placed under light isoflurane anesthezia during the administration.
No massage was performed but the tip was used to spread the preparation over the application site. No rinsing was performed.
The maximum concentration of the test item was selected to avoid overt systemic toxicity and excessive local skin irritation the latter being defined by an > 25% increase of the ear thickness. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- not required
- Positive control results:
- The threshold positive value of 3 for the SI was reached in the positive control group (SI = 3.53). The experiment was therefore considered valid.
- Key result
- Parameter:
- SI
- Value:
- 0.41
- Test group / Remarks:
- 5%
- Key result
- Parameter:
- SI
- Value:
- 0.74
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 0.63
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 1.38
- Test group / Remarks:
- 50%
- Key result
- Parameter:
- SI
- Value:
- 2.79
- Test group / Remarks:
- 100
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide is not classified as a skin sensitiser in a Local lymph node assay in mouse according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and the Directive 67/548/EEC.
- Executive summary:
In a local lymph node assay performed according to the OECD guideline No. 429 and in compliance with the GLP, 8-weeks old female CBA/J mice, were exposed to Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide (purity of 99.3%) undiluted or diluted in Dimethylformamide (DMF).
A preliminary test was first performed in order to define the test item concentrations to be used in the main test. Two groups of two mice received the test item by topical route to the dorsal surface of both ears (one concentration per ear) on days 1, 2 and 3 at concentrations of 10, 25, 50 or 100% under a dose-volume of 25 µL. From day 1 to day 3 then on day 6, the thickness of both ears of each animal was measured and the local reactions were recorded. Each animal was observed at least once a day for mortality and clinical signs. Body weight was recorded once during the acclimation period, and then on days 1 and 6. No local reactions were observed in any animals up to the highest concentration (100%). The percentage of ear thickness increase compared to day 1 was less than 10% in all animals and at all concentrations. Therefore the test item is considered as non-irritant and the maximum concentration of 100% was chosen for the main study.
In the main study, 4 mice/concentration were topically treated with the test item at concentrations in DMF of 0; 5; 10; 25; 50 and 100 %. The topical application was performed on to the dorsal surface of both ears on days 1, 2 and 3 under a dose-volume of 25 µL. Additionally, one positive control group of four females received the positive control, α‑hexylcinnamaldehyde (HCA), at 25% in a mixture acetone/olive oil (4/1; v/v) under the same experimental conditions. From day 1 to day 3 then on day 6, the thickness of the left ear of each animal was measured, except in animals of the positive control group, and the local reactions were recorded. Each animal was observed at least once a day for mortality and clinical signs. Body weight was recorded once during the acclimation period, and then on days 1 and 6.
After 2 days of resting, on day 6, the animals received a single intravenous injection of tritiated methyl thymidine (3H-TdR). Approximately 5 hours later, the animals were sacrificed and the auricular lymph nodes were excised. The proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of 3H-TdR.
The results were expressed as disintegrations per minute (dpm) per group and as dpm/node. The obtained values were used to calculate Stimulation Indices (SI).
No unscheduled death occurred during the study and no clinical signs were observed in any animals. The body weight change of test item-treated animals was similar to that of control animals. The threshold positive value of 3 for the SI was reached in the positive control group (SI = 3.53). The experiment was therefore considered valid.The stimulation index of the treated animals increased with the test item concentration, but was never higher or equal to 3 (max 2.79 for the 100% concentration). Dryness of the skin was observed on day6 in1/4 female treated at the concentration of 100%. No notable increase in ear thickness was observed at any tested concentrations.
Therefore under the test conditions, Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide is not classified as a skin sensitiser in a Local lymph node assay in mouse according to the criteria of the Regulation (EC) No. 1272/2008 (CLP) and the Directive 67/548/EEC.
This study is considered as acceptable and satisfies the requirement for skin sensitisation endpoint.
Reference
No unscheduled death occured during the study, and no clinical signs were observed in any animals. The body weight change of test item-treated animals was similar to that of control animals.
Table 7.4.1/1: Results of the proliferation assay (mean values)
Groups |
Treatment and concentrations |
Number of node per group |
dpm per group |
dpm per node |
Stimulation index (SI) |
Increase on ear thickness (% between day 1 and 6) |
Irritation level |
EC3value |
3 |
Vehicle |
8 |
5103 |
637.88 |
- |
-4.81 |
- |
- |
4 |
Test item 5% |
8 |
2117 |
264.63 |
0.41 |
-4.72 |
I |
N/A |
5 |
Test item 10% |
8 |
3760 |
470.00 |
0.74 |
-5.71 |
I |
|
6 |
Test item 25% |
8 |
3229 |
403.63 |
0.63 |
-3.77 |
I |
|
7 |
Test item 50% |
8 |
7067 |
883.38 |
1.38 |
-3.88 |
I |
|
8 |
Test item 100% |
8 |
14214 |
1776.75 |
2.79 |
-7.41 |
I |
|
9 |
HCA 25% |
8 |
18008 |
2251.00 |
3.53 |
- |
- |
- |
N/A: Not Applicable
dpm: Disintegrations per minute
HCA: α-hexylcinnamaldehyde
I: non-irritant (increase in ear thickness < 10%)
EC3 value: theoretical concentration resulting in a SI value of 3
Stimulation Index = dpm of treated group / dpm of control group
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Only one study available.
In a GLP-compliant local lymph node assay performed similarly to the OECD guideline No. 429, female CBA/J mice were exposed to Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamide undiluted or diluted in Dimethylformamide. According to the results regarding the skin irritation obtained in a preliminary assay, the following concentrations were selected for the main test: 0; 5; 10; 25; 50 and 100 %. In the main study, a topical application of the test item was performed at the different concentrations (4 mice/concentration) on the dorsal surface of both ears on days 1, 2 and 3. Additionally, one positive control group of four females received the positive control, α‑hexylcinnamaldehyde (HCA), at 25% in a mixture acetone/olive oil (4/1; v/v). After 2 days of resting, on day 6, the animals received a single intravenous injection of tritiated methyl thymidine (3H-TdR). Approximately 5 hours later, the animals were sacrificed and the auricular lymph nodes were excised. The proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of 3H-TdR.
No unscheduled death occured during the study, and no clinical signs were observed in any animals. The body weight change of test item-treated animals was similar to that of control animals. The threshold positive value of 3 for the Stimulation Index (SI)I was reached in the positive control group (SI = 3.53). The experiment was therefore considered valid.The stimulation index of the treated animals increased with the test item concentration, but was never higher or equal to 3 (max 2.79 for the 100% concentration). Dryness of the skin was observed on day 6 in1/4 female treated at the concentration of 100%. No notable increase in ear thickness was observed at any tested concentrations. The test item is not considered as a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Harmonized classification:
No harmonized classification is available according to the Regulation (EC) No 1272/2008 including ATP3.
Self classification:
Reaction mass of methacrylic acid and N-[2-(2-oxoimidazolidin-1-yl)ethyl]methacrylamideis not classified for skin sensitisation according to the Regulation (EC) 1272/2008 (CLP) and to the Directive 67/548/EEC as the SI obtained with the test item was lower than 3 in the LLNA.
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