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EC number: 688-147-2 | CAS number: 82428-30-6
- 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
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:
- April - May 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Species/strain: healthy CBA/CaOlaHsD mice
- Source: Harlan Laboratories
- Sex: female (nulliparous and non-pregnant)
- Age at the beginning of the study: 9-10 weeks
- Number of animals: 5 mice / group, 7 mice / prescreen test
The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No. 7 of the German Act on Animal Welfare the animals are bred for experimental purposes.
The animals were randomly selected. Identification was ensured by cage number and individual marking (tail).
HOUSING AND FEEDING CONDITIONS
- Full barrier in an air-conditioned room
- Temperature: 22 ± 3 °C
- Relative humidity: 55 ± 10%
- Artificial light, sequence being 12 hours light, 12 hours dark
- Air change: at least 10 x / hour
- Free access to Altromin 1324 maintenance diet for rats and mice (prescreen test and main study: lot no. 1526)
- Free access to tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- The animals were kept in groups of 5 animals in IVC cages, type II L, polysulphone cages on Altromin saw fibre bedding (prescreen test: lot no. 131113, main study: lot no. 290114)
- Certificates of food, water and bedding are filed at the test institute
- Adequate acclimatisation period (at least five days) under laboratory conditions
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 12.5, 25 and 50%
- No. of animals per dose:
- 5
- Details on study design:
- The LLNA has been developed as an alternative method for the identification of skin sensitising test items and measures the proliferation of lymphocytes isolated from lymph nodes (auricular lymph nodes) draining the site of exposure (dorsal aspect of the ears) in mice.
Lymphocyte proliferation is measured by determining the incorporation of 3H-methyl thymidine (TRK 300, 20 Ci/mmol, Lot 201310E, diluted to a working concentration of 80 µCi/mL). - Positive control substance(s):
- other: Reliability check with p-phenylenediamine (CAS 106-50-3, > 94%) in May 2014 (BSL Project ID 134702 Z)
- Positive control results:
- RELIABILITY CHECK (May 2014, mean values):
Negative Control (vehicle):
- CPM 827.4
- DPM 2155.8
- SI 1.0
Positive Control (p-phenylenediamine):
- CPM 5616.0
- DPM 14577.8
- SI 6.8 - Parameter:
- SI
- Remarks:
- mean
- Value:
- 2.8
- Test group / Remarks:
- 12.5% test item
- Remarks on result:
- other: no signs of systemic toxicity nor excessive irritation
- Parameter:
- SI
- Remarks:
- mean
- Value:
- 4.6
- Test group / Remarks:
- 25% test item
- Remarks on result:
- other: further observation: sticky fur (day 3-5)
- Key result
- Parameter:
- EC3
- Value:
- 13.89
- Test group / Remarks:
- derived by linear interpolation
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The EC3 value (derived by linear interpolation) was calculated to be at a test item concentration of 13.89%.
The measurement of the ear thickness did not revealany relevant increase of the ear thickness in any dosage group.
Consequently, according to OECD 429, solutions or preparations containing more than 13.89% 3,4-Epoxycyclohexylmethyl methacrylate are expected to have a stimulation index of >3, and are therefore considered to be dermal sensitisers.
According to Commission Regulation (EU) No 286/2011 as well as GHS (Globally Harmonized Classification System) the test item 3,4-Epoxycyclohexylmethyl methacrylate has obligatory labelling requirement for skin sensitisation and is classified into Category 1B. - Executive summary:
SUMMARY
On the basis of the test results given below and in conformity with the criteria given in Commission Regulation (EU) No 286/2011 the substance should be:
- classified into sub-category 1B
On the basis of the test results given below and in conformity with the criteria given in GHS (Globally Harmonized Classification System) the substance should be:
- classified into sub-category 1B
Based on the results of the prescreen test the test item was assessed for sensitising properties at concentrations of 12.5%, 25% and 50% (v/v), each diluted with AOO 4:1 (v/v). Animals which showed adverse clinical findings or were euthanized for ethical reasons were excluded from the calculation.
Species/strain: Mice, CBA/CaOlaHsd
Number of animals: 20/main test
Vehicle: AOO (4:1 (v/v) acetone/olive oil)
One of the two tested concentrations exceeded the stimulation index of 3.
The stimulation index at a concentration of 12.5% was 2.8
The stimulation index at a concentration of 25% was 4.6
The stimulation index at a concentration of 50% could not be measured as the animals treated with a 50% concentration were euthanized for ethical reasons on day 3.
Reference
PRESCREEN TEST
No signs of excessive irritation indicated by an erythema score ≥ 3 and/or ear swelling of ≥ 25% were detected in any animal.
The animals treated with the undiluted test item as well as the animals treated with the test item at a concentration of 50% in AOO showed signs of systemic toxicity (weight loss > 10%).Therefore, animal no. 1, 2 and 3 were sacrificed for ethical reasons on day 3. All other clinical findings (sticky fur, found in animal no. 1 to 5) were considered not to be signs of systemic toxicity or signs of excessive irritation.
No signs of irritation were detected in the animals treated with the negative control.
All surviving animals showed the expected weight development, which includes a weight loss of up to 2 g (ca. 5-10%) throughout the duration of the prescreen test.
Group | Animal No. | Weight change [g] | Weight change [%] | Systemic Effects | Local Effects |
100% | 1* | -3 | -14.29 | weight loss | sticky fur |
100% | 2* | -3 | -15.00 | weight loss | sticky fur |
50% | 3* | -3 | -14.29 | weight loss | sticky fur |
50% | 4 | 1 | 4.76 | - | sticky fur |
25% | 5 | -1 | -4.55 | - | sticky fur |
25% | 6 | 1 | 4.55 | - | - |
Control | 7 | 0 | 0.00 | - | - |
* euthanised on day 3
MAIN STUDY
One of the two tested concentrations exceeded the stimulation index of 3.
The stimulation index at a concentrationof 12.5% was 2.8
The stimulation index at a concentrationof 25% was 4.6
The stimulation index at a concentration of 50% could not be measured.
No signs of excessive irritation indicated by an erythema score ≥ 3 and/or ear swelling of ≥ 25%were detected in any animal.
The animals treated with the test item at a concentration of 50% in AOO showed signs of systemic toxicity (weight loss > 10%) Therefore, the animals of the 50% test group were sacrificed for ethical reasons on day 3.
In all animals treated with the test item at a concentration of 50% in AOO and a concentration of 25% in AOO sticky fur was observed from day 2 (50% concentration) or from day 3 (25% concentration) until day 5.
Neither signs of systemic toxicity nor signs of excessive irritation at any application site could be detected in any animal treated with the test item at a concentration of 12.5% in AOO.
A weight loss of 3 g was observed in 4 out 5 animals treated with the test item at the concentration of 50 % on day 3. Therefore the animals were euthanized for ethical reason. The remaining animals showed the expected weight development, which includes a weight loss of up to 2 g (ca. 5-10%) throughout the study.
Group | Animal No. | Weight change [g] | Weight change [%] | Systemic Effects | Local Effects |
12.5% | 1 | 1 | 4.55 | no findings | no findings |
2 | 0 | 0.00 | |||
3 | 1 | 4.17 | |||
4 | 1 | 4.76 | |||
5 | 1 | 4.76 | |||
25% | 6 | -2 | -8.70 | no findings | wet fur (neck) day 3 -5 |
7 | -1 | -4.55 | |||
8 | 0 | 0.00 | |||
9 | 1 | 4.35 | |||
10 | 0 | 0.00 | |||
50% | 11* | -3 | -12.50 | weight loss > 10% on day 3* | wet fur (neck) day 2 -3* |
12* | -3 | -13.64 | |||
13* | -3 | -15.00 | |||
14* | -2 | -8.70 | |||
15* | -3 | -13.04 | |||
Control | 16 | 0 | 0.00 | no findings | no findings |
17 | 0 | 0.00 | |||
18 | 1 | 4.55 | |||
19 | -1 | -5.26 | |||
20 | 0 | 0.00 |
* euthanised on day 3
The means of the ear thickness per group showed no relevant difference compared to the negative control:
Mean ear thickness | day 1 | day 3 | day 6 |
12.5% test group | 0.18 mm | 0.18 mm | 0.18 mm |
25% test group | 0.18 mm | 0.19 mm | 0.19 mm |
50% test group | 0.18 mm | 0.18 mm | - |
negative control group | 0.18 mm | 0.18 mm | 0.18 mm |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Migrated from Short description of key information:
sensitising | mouse (female) | OECD 429 |
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
3,4-Epoxycyclohexylmethyl methacrylate was tested for skin sensitization in a GLP-compliant study according to OECD TG 429 (LLNA, Klimisch 1). Under the conditions of the study, an EC3 value of 13.89% was derived. On the basis of the outcome of this assay, 3,4-epoxycyclohexylmethyl methacrylate has to be classified as skin sensitizer.
Justification for classification or non-classification
The available data suggest a skin sensitization potential. Therefore, 3,4-epoxycyclohexylmethyl methacrylate has to be classified accordingly with "Skin Sens. 1B, H317" under the CLP regulation (Regulation (EC) 1272/2008).
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