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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 212-825-5 | CAS number: 872-36-6
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 5 - 17 March 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
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
- 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)
Test material
- Reference substance name:
- Vinylene carbonate
- EC Number:
- 212-825-5
- EC Name:
- Vinylene carbonate
- Cas Number:
- 872-36-6
- Molecular formula:
- C3H2O3
- IUPAC Name:
- 2H-1,3-dioxol-2-one
- Details on test material:
- - Name of test material (as cited in study report): VC
- Substance type: organic
- Physical state: solid (under storage conditions)
- Test material was warmed at 25°C in a warming bath to produce a liquid before use.
- Analytical purity: >99.9%
- Lot/batch No.: 0801102
- Expiration date of the lot/batch: 31 December 2008
- Stability under storage conditions: stable
- Storage condition of test material: In refrigerator (2-8°C) protected from light and under nitrogen. Avoid contact with air and water.
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, L’Arbresle Cedex, France
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: 19-23 g
- Housing: Individual housing in labeled Macrolon cages
- Diet (e.g. ad libitum): Free access to pelleted rodent diet
- Water (e.g. ad libitum): ad libitum
- Acclimation period: The acclimatization period was at least 5 days before the start of treatment under laboratory conditions. Accommodation was as described above except that the animals were group housed in Macrolon cages
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6 – 23.5
- Humidity (%): 32 - 74
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- Preliminary study: 100, 50, 25, 10, 5, 2.5 and 1%
Main study: 50, 25, 10 and 0% - No. of animals per dose:
- 5
- Details on study design:
- - Compound solubility: The test substance formulations (w/w) were prepared within 4 hours prior to each treatment. The test substance was heated in a water bath with a maximum temperature of 26°C for a maximum of 4 hours and 13 minutes in order to obtain a liquid before use. Homogeneity was obtained to visually acceptable levels.
RANGE FINDING TESTS:
- Irritation: No irritation was observed in any of the animals examined. The animal at 100% showed hunched posture, piloerection, uncoordinated movements, hypothermia and body weight loss on Day 3. No symptoms of systemic toxicity were noted in the animal at 50%.
Based on the results, the highest test substance concentration selected for the main study was a 50% concentration.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response:
DPM values are presented for each animal and for each dose group. A Stimulation Index (SI) is calculated for each group. The SI is the ratio of the DPM/group compared to DPM/vehicle control group.
If the results indicate a SI >= 3, the test substance may be regarded as a skin sensitiser, based on the test guideline and recommendations done by ICCVAM.
The results were evaluated according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations and the EC criteria for classification and labeling of dangerous substances and preparations (Council Directive 67/548/EEC and all adaptations to technical progress and amendments of this Directive published in the Official Journal of the European Communities).
Consideration was given to the EC3 value (the estimated test substance concentration that will give a SI =3).
TREATMENT PREPARATION AND ADMINISTRATION: by open application on the ears
Three days after the last exposure, all animals were injected with 3H-methyl thymidine and after five hours the draining (auricular) lymph nodes were excised.
After precipitating the DNA of the lymph node cells, radioactivity measurements were performed. The activity was expressed as the number of Disintegrations Per Minute (DPM) and a stimulation index (SI) was subsequently calculated for each group. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Not performed.
Results and discussion
- Positive control results:
- The six monthly reliability check with Hexylcinnamaldehyde, indicates that the Local Lymph Node Assay as performed at NOTOX is an appropriate model for testing for contact hypersensitivity.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: The SI values calculated for the substance concentrations 10 and 25% were 3.3 and 2.1 respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see Remark
- Remarks:
- Median DPM/animal values are reported due to possible outlier responses for individual animals within groups. Median DPM/animal values for the experimental groups treated with test substance concentrations 10 and 25% were 1689 and 1103 respectively. The median DPM/animal value for the vehicle control group was 518.
Any other information on results incl. tables
On Day 6, two animals at 50% showed hunched posture and piloerection. In addition, marked body weight loss was noted among the animals at 50%. Based on signs of systemic toxicity, the results of the group at 50% could not be used for interpretation.
No skin reactions were observed in any of the control animals and animals at 10 and 25% examined.
All nodes of the control group and groups at 10 and 25% were considered normal in size.
No macroscopic abnormalities of the surrounding area were noted.
Body weights and body weight gain of experimental animals at 10 and 25% remained in the same range as controls over the study period.
No mortality occurred and no symptoms of systemic toxicity were observed in the control animals and animals at 10 and 25% of the main study.
The results indicate that the test substance could elicit a SI >= 3.
The data showed an inverse dose-response and no reliable EC3 value could be calculated. The inverse dose response might be due to underlying systemic toxicity, since animals at 50% showed signs of systemic toxicity. It was possible to strengthen the outcome of the study by adding lower concentrations. Since the SI value at 10% exceeded 3 and since extension of the study would not alter the classification, this was considered not appropriate for ethical reasons.
Applicant's summary and conclusion
- Interpretation of results:
- other: skin sensitizer
- Conclusions:
- Based on the results of this study, it can be concluded that:
- according to the recommendations made in the test guidelines, VC would be regarded as skin sensitizer.
- according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations (2004), VC should be classified as skin sensitizer (Category 1).
- according to the EC criteria for classification and labeling requirements for dangerous substances and preparations (Council Directive 67/548/EEC), VC should be labeled as: may cause sensitization by skin contact (R 43). - Executive summary:
Assessment for Contact Hypersensitivity to VC in the Mouse (Local Lymph Node Assay) was performed according to OECD 429. In the main study, three groups of five experimental animals were treated with test substance concentrations of 10%, 25% or 50% on three consecutive days, by open application on the ears. The SI values calculated for the substance concentrations 10 and 25% were 3.3 and 2.1 respectively, indicating that the test substance could elicit a SI>= 3. Based on these results, VC should be regarded as skin sensitizer.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)