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EC number: 214-012-0 | CAS number: 1072-63-5
- 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
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Endpoint summary
Administrative data
Description of key information
1-Vinyl-imidazole was found not to be irritating to the rabbit skin under semi-occlusive conditions, although it was tested to be corrosive to the skin in vitro.
The test substance was found to be corrosive to the rabbit eye and a single application of 10% 1-vinyl-imidazole to the chorionallantoic membrane of eggs caused intravascular coagulation and haemorrhages.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Centre Lago S.A. (01540 Vonnas, France)
- Age at study initiation: 7-8 months
- Weight at study initiation: 3.91-4.35 kg
- Housing: individually in stainless steel wire mesh cages with grating, floor area : 3000 cm2
- Diet: Kliba-Labordiät, Kaninchen & Meerschweinchenhaltung "GLP" (Provimi Kliba SA, Kaiseraugst, Basel, Switzerland), ca. 130 g/animal per day
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated skin of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days but study was discontinued after 7 days because all animals were free of findings
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsolateral part of the trunk
- % coverage: 2.5 x 2.5 cm
- Type of wrap: semiocclusive (test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull® stretch (adhesive fleece), Beiersdorf AG)
REMOVAL OF TEST SUBSTANCE
- Washing: with Lutrol and Lutrol/water 1:1
- Time after start of exposure: after 4 hours of exposure
SCORING SYSTEM: as described in OECD guideline 404 - Irritation parameter:
- erythema score
- Remarks:
- 1 h exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Remarks:
- 1 h exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no edema observed
- Irritation parameter:
- erythema score
- Remarks:
- 4 h exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- 4 h exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- erythema score
- Remarks:
- 4 h exposure
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Remarks:
- 4 h exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no edema observed
- Irritation parameter:
- edema score
- Remarks:
- 4 h exposure
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no edema observed
- Irritation parameter:
- edema score
- Remarks:
- 4 h exposure
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no edema observed
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Method: BASF test: 50 µl of the test substance were applied to the conjunctival sac of one eye in 2 animals. The animals were observed up to 24 days after treatment. Findings were recoded daily.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- not specified
- Vehicle:
- water
- Controls:
- other: untreated eyes of the same animals
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.05-0.1 mL
- Concentration (if solution): undiluted and 10, 5, 1 and 0.1% aqueous solution - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- up to 24 days
- Number of animals or in vitro replicates:
- 2 for undiluted test substance, 1 per aqeous solution (10, 5, 1 and 0.1%)
- Irritation parameter:
- other: severe redness of the conjunctivae, secretion of pus, bleeding of the conjunctivae, ciliary injection and severe oedema
- Basis:
- animal: 2 animals
- Reversibility:
- other: Corneal cloudiness was still reported at the end of the observation period (d24).
- Remarks on result:
- probability of severe irritation
- Irritant / corrosive response data:
- The pure substance caused severe redness of the conjunctivae, secretion of pus, bleeding of the conjunctivae, ciliary injection and severe oedema. Cloudiness of the cornea was still reported at the end of the observation period (day 24).
The 10 and 5% solutions caused redness and swelling of the conjunctivae, which had disappeared 2 to 3 days after exposure.
The 1 and 0.1% solutions caused slight redness of the conjunctivae, which had disappeared 1 day after exposure. - Interpretation of results:
- corrosive
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- HET-CAM in vitro corrosion test (alternative method to study the potential of serious damage to the eyes/mucous membranes in incubated hen eggs). The study was performed according to the methods described in the following publications:
- Lüpke N.P. (1985): Hen's Egg Chorio allantoic Membrane Test for Irritation Potential. Fd. Chem. Toxic. 23, pp. 287 - 291.
- Spielmann, H. (1995): HET-CAM Test. In: Methods in Molecular Biology, 43 (eds.: O'Hare, S. and Atterwill, C. K.) pp. 199 - 204.
- Spielmann, H. et al. (1996): Results of a Validation Study in Germany on Two In Vitro Alternatives to the Draize Eye Irritation Test the HET-CAM Test and the 3T3 NRU Cytotoxicity Test. ATLA 24, pp. 741 - 858. - GLP compliance:
- yes (incl. QA statement)
- Species:
- other: chorionallantoic membrane of fertilized hen eggs
- Strain:
- other: White Leghorn
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH (Exertal, Germany)
- Age at study initiation: fresh, fertilized hen eggs
- Weight at study initiation: 53.7 - 59.9 g
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 37.5 (± 0.5), breeding in an incubator
- Humidity (%): 62.5 (± 7.5) - Vehicle:
- water
- Remarks:
- doubly distilled
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amounts applied: 0.3 mL unchanged solution or 0.3 mL of a 10% solution in water - Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- Up to 3.5 minutes
- Number of animals or in vitro replicates:
- 3 eggs per dose
- Details on study design:
- SCORING SYSTEM:
After application of the test substance the chorionallantoic membrane was observed by means of a stereomicroscope until unambiguous irritation reactions were detected or up to a maximum time period of 3.5 minutes, respectively. The time of appearance (in seconds after application) of intravascular resp. extravascular coagulation and, if applicable, other reactions (haemorrhagia, vessel lysis) were determined.
The evaluation of the reactions was performed according to the following grading:
0 = no visible change
1 = slight reaction
2 = moderate reaction
3 = severe reaction
EVALUATION CRITERIA:
The evaluation depends on the solubility of the test substance, the tested concentrations and the time until appearance of unambiguous intravascula coagulation of middle-sized vessels or extravascular coagulation of the treated CAM, respectively. The mean time until appearance of reaction over the eggs of a treatment group was calculated (mean time to coagulation = mtc in seconds).
mtc(10%) = mean time to coagulation of a 10% solution in seconds
mtc(100%) = mean time to coagulation of the unchanged test substance in seconds
Water-soluble test substances
mtc(10%) < 90; risk of serious damage to the eyes
mtc(10%) ≥ 90; no risk of serious damage to the eyes
Usually the result of a 10% aqueous solution is used for evaluation. If the unchanged test substance (mtc100%) is considerable more reactive than the 10% solution, further information on the properties of the test substance or results from structurally related compounds will be taken into account for evaluation.
TOOL USED TO ASSESS SCORE: stereomicroscope - Irritation parameter:
- other: mtc(10%) in sec
- Value:
- > 30 - < 62
- Remarks on result:
- other: moderate intravascular coagulation in all eggs
- Irritation parameter:
- other: mth(10%) in sec
- Value:
- > 25 - < 30
- Remarks on result:
- other: moderate haemorrhagia
- Irritation parameter:
- other: mtc(100%) in sec
- Value:
- > 6 - < 11
- Remarks on result:
- other: moderate intravascular coagulation in all eggs
- Irritation parameter:
- other: mth(100%) in sec
- Value:
- > 3 - < 6
- Remarks on result:
- other: moderate haemorrhagia
- Other effects / acceptance of results:
- mtc(10%) - mean time of coagulation of a 10% test solution
mth(10%) - mean time of haemorrhagia of a 10% test solution
mtc(100%) - mean time of coagulation of a 100% test solution
mth(100%) - mean time of haemorrhagia of a 100% test solution
With a mtc(10%) < 90, a risk of serious damage to the eyes is concluded to be possible. - Interpretation of results:
- other: severe eye damage in the HET-CAM test
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation
1-Vinyl-imidazole was applied to the skin of New Zealand White rabbits for 4 hours (using 2 animals at all exposure durations) under semi-occlusive conditions and observed for 14 days in a GLP compliant OECD404 study (2005; RL2). The exposure period of 4 hours caused moderate erythema in all animals immediately and 1 hour after removal of the patch. Moderate erythema persisted in one animal up to 24 hours and decreased to slight after 48 and 72 hours. In two animals moderate erythema decreased to slight after 24 hours and persisted up to 48 hours. No other cutaneous reactions were observed during the study. The cutaneous reactions were reversible in two animals within 72 hours and in one animal within 7 days after removal of the patch. Mean scores over 24, 48 and 72 hours for each animal were 0.7, 0.7 and 1.3 for erythema and 0.0 for edema. The study was discontinued after 7 days because all animals were free of findings. 1-Vinyl-imidazole was judged not irritating to the skin.
In a pre-GLP and pre-guidline study in vivo (1953; RL2), 2 rabbits were exposed occlusively for 20 h to the test substance; undiluted, 50, 10 and 5 % aqueous solution, inducing slight irritation. The study was not taken into account for classification due to the worse conditions compared to the OECD404 study above.
In an in vitro corrosivity test (EpiDerm, 2005; RL2) the viability of the test substance treated tissue determined after an exposure of 3 min was 56 % and 12 % after 1 h exposure. This is near the threshold for the evaluation criteria (corrosive / non-corrosive) of 50 % viablilty after 3 min exposure and 20 % after 1 h exposure. The study was not taken into account for classification due to the OECD404 study above.
In conclusion, 1 -vinyl-imidazole is considered to be not irritating to the skin because of the results of the OECD404 study above.
Eye irritation
1-Vinyl-imidazole was tested in a HET-CAM in vitro corrosion test under GLP-compliant conditions (2005; RL2). The chorionallantoic membrane of the eggs treated with a 10 % test substance solution in double distilled water showed moderate (grade 2) intravascular coagulation in all eggs after 30 - 62 seconds (mean: 51 seconds). Moderate haemorrhages (grade 2) were observed in all eggs after 25 - 30 seconds (mean: 28 seconds). The unchanged test substance caused moderate (grade 2) intravascular coagulation in all eggs after 6 - 11 seconds (mean: 9 seconds). Moderate (grade 2) haemorrhages were observed in all eggs after 3 - 6 seconds (mean: 4 seconds).
Supportingly, in a pre-GLP and pre-guideline in vivo study (1953, RL2) the single application of the undiluted test substance to two rabbit eyes induced severe redness of the conjunctivae, secretion of pus, bleeding of the conjunctivae, ciliary injection and severe oedema. Cloudiness of the cornea was still reported at the end of the observation period (day 24). Application of an aqueous solution of the test substance (10, 5, 1 or 0.1%; one animal each) induced redness and swelling for 2 to 3 days or only slight redness for 1 day.
Based on the results of the in vitro study and its evaluation criteria and the supporting effects of the undiluted substance in the in vivo study, 1-vinyl-imidazole is considered to cause severe eye damage.
Justification for classification or non-classification
Based on the available data, 1-vinyl-imidazole needs to be classified for risk of serious damage to the eyes according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 (Eye Damage 1, H318).
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.
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