Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 700-487-6 | 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
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:
- 2010-07-20 - 2010-08-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- During the acclimation phase of the animals used for the pre-experiment, the relative humidity in the animal room was between approximately 45 - 76 % for a few hours and the temperature was between 22 + 3°C for a few hours.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Vehicle:
- dimethylformamide
- Concentration:
- The test item in the main study was assayed at 10, 25, and 50%. The top dose is the highest technically achievable concentration whilst avoiding systemic toxicity and excessive local irritation.
- No. of animals per dose:
- 4 females for each test group and 4 females for control group
- Details on study design:
- Topical Application
Each test group of mice was treated by topical (epidermal) application to the dorsal surface of each ear with test item concentrations of 10, 25, and 50% (w/w) in dimethylformamide. 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 was treated with an equivalent volume of the relevant vehicle alone (control animals).
Administration of 3H-Methyl Thymidine
3H-methyl thymidine (3HTdR) was purchased from Hartmann Analytic, 38124 Braunschweig, Germany (specific activity, 2 Ci/mmol; concentration, 1 mCi/mL).
Five days after the first topical application, all mice were administered with 250 µL of 81.8 µCi/mL 3HTdR (corresponds to 20.5 µCi 3HTdR per mouse) by intravenous injection via a tail vein.
Determination of Incorporated 3HTdR
Approximately five hours after treatment with 3HTdR all mice were euthanised by intraperitoneal injection of Pentobarbital-Natrium (Release, WDT, 30827 Garbsen, Germany).
The draining lymph nodes were rapidly excised and pooled per group (8 nodes per group). 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 plastic scintillation vials with 10 mL of ‘Ultima Gold’ scintillation liquid (Perkin Elmer (LAS) GmbH, 63110 Rodgau, Germany) and thoroughly mixed.
The level of 3HTdR incorporation was then measured on a β-scintillation counter (Tricarb 2900 TR, Perkin Elmer (LAS) GmbH, 63110 Rodgau, Germany). Similarly, background 3HTdR levels were also measured in two 1mL-aliquots of 5 % trichloroacetic acid. The β-scintillation counter expresses 3HTdR incorporation as the number of radioactive disintegrations per minute (DPM).
Interpretation of Raw Data
The proliferative response of lymph node cells is expressed as the number of radioactive disintegrations per minute per lymph node (DPM/node) and as the ratio of 3HTdR incorporated into lymph node cells of test lymph nodes relative to that recorded for control lymph nodes (Stimulation Index; S.I.). Before DPM/node values were determined, mean scintillation-background DPM was subtracted from test and control raw data.
A test item is regarded as a sensitiser in the LLNA if the following criteria are fulfilled:
- First, that exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the stimulation index.
- Second, that the data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- Concentration SI
0 % 1.00
5 % 2.04
10 % 3.41
25 % 6.14 - Parameter:
- SI
- Remarks on result:
- other: Concentration SI 10 % 3.76 25 % 8.04 50 % 9.54
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Concentration DPM per lymph node 10 % 1679 25 % 3591 50 % 4260
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
- Conclusions:
- In this study Stimulation Indices of 3.76, 8.04, and 9.54 were determined with the test item at concentrations of 10, 25, and 50% in dimethylformamide. The EC3 value could not be calculated, since all obtained SI were above 3. The test item Epoxy half acrylate was found to be a skin sensitiser under the described conditions.
- Executive summary:
In the study Epoxy half acrylate dissolved in dimethylformamide was assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay was performed using test item concentrations of 10, 25, and 50% (w/w).
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
In this study Stimulation Indices (S.I.) of 3.76, 8.04, and 9.54 were determined with the test item at concentrations of 10, 25, and 50% in dimethylformamide, respectively.
The test item Epoxy half acrylate was found to be a skin sensitizer under the test conditions of this study.
Reference
Calculation and Results of Individual Data
(Vehicle: dimethylformamide)
Test item concentration % (w/w) |
Group |
Measurement DPM |
Calculation |
Result |
||
DPM-BGa) |
number of lymph nodes |
DPM per lymph nodeb) |
S.I. |
|||
--- |
BG I |
15 |
--- |
--- |
--- |
--- |
--- |
BG II |
25 |
--- |
--- |
--- |
--- |
--- |
1 |
3593 |
3573 |
8 |
446.6 |
1.00 |
10 |
2 |
13453 |
13433 |
8 |
1679.1 |
3.76 |
25 |
3 |
28748 |
28728 |
8 |
3591.0 |
8.04 |
50 |
4 |
34100 |
34080 |
8 |
4260.0 |
9.54 |
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
1 = Control Group
2-4= Test Group
S.I. = Stimulation Index
a) = The mean value was taken from the figures BG I and BG II
b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
The EC3 value could not be calculated, since all S.I.´s are above 3.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin Sensitisation
In a dermal sensitisation study with Epoxy half acrylate dissolved in dimethylformamide groups of 4 female CBA mice were tested using the LLNA method according to the OECD Guideline 429, 24 April 2002. Proliferation response of lymph node cells was measured by DPM counting of incorporated 3HTdR. A substance is regarded as dermally sensitising if the stimulation index S.I. ≥ 3.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed.
Stimulation indices of 3.76, 8.04, and 9.54 were determined with the test item at concentrations of 10, 25, and 50% in dimethylformamide, respectively The test item was found to be a skin sensitiser under the test conditions of this study.
No EC3 to estimate the sensitisation potency could be calculated from the study as all S.I. were above 3. However, the data were linearly extrapolated resulting in an EC3 of 7.35%. Based on this, Epoxy half acrylate is considered to be a moderate sensitiser in accordance with the Guidance on the Application of the CLP Criteria, Version 4, November 2013.
There is no data gap for skin sensitisation. Although no human data are available for Epoxy half acrylate, there is no reason to believe that results obtained in mice would not be applicable to humans.
Respiratory sensitisation
There is no information available for respiratory sensitisation. Therefore, there is a data gap in this respect. However, the data gap cannot be fulfilled with experimental data, since there is no internationally accepted animal model for respiratory sensitisation. In case human data for respiratory sensitisation emerges, this will be taken into account.
Migrated from Short description of key information:
Sensitising (OECD TG 429, GLP) S.I. were 3.76, 8.04, and 9.54 at concentrations of 10, 25, and 50% in dimethylformamide
Justification for selection of skin sensitisation endpoint:
OECD guideline study, GLP
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available reliable, relevant and adequate data, Epoxy half acrylate is classified as skin sensitiser (Category 1, H317: May cause an allergic skin reaction) according to regulation (EC) 1272/2008.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.