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EC number: 203-309-0 | CAS number: 105-56-6
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
Test material
- Reference substance name:
- Ethyl cyanoacetate
- EC Number:
- 203-309-0
- EC Name:
- Ethyl cyanoacetate
- Cas Number:
- 105-56-6
- Molecular formula:
- C5H7NO2
- IUPAC Name:
- ethyl 2-cyanoacetate
- Details on test material:
- Batch No. 03083263
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 6 to 7 weeks
- Weight at study initiation: weight range of 320 to 377 g
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 21°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 h dark / 12h light
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- induction: approximately 0.5ml undiluted ethyl cyanoacetate
challenge: approximately 0.5ml undiluted ethyl cyanoacetate
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- induction: approximately 0.5ml undiluted ethyl cyanoacetate
challenge: approximately 0.5ml undiluted ethyl cyanoacetate
- No. of animals per dose:
- 10
- Details on study design:
- A. INDUCTION EXPOSURE
- The skin of the left shoulder region of each animal was clipped free of hair with an electric clipper.
- A 20 x 20 mm patch of surgical gauze was saturated with ca. 1.5 ml of ethyl cyanoacetate, as supplied
- No. of exposures: 3
- Exposure period: one induction application was made on day 1, 8, 15
- Contact of the test substance with the skin was approxitmately 6 hours for each induction exposure
- Evaluation: The challenge sites wwere evaluated 24, 48 and 72 hours after removal of the patches
- Induction of control animals: the 10 control animals were treated similary to the test animals with the exeption that the test compound was omitted
from the induction applications
- The dermal reaction were observed 30 min and ca. 24 h after after each induction application in both controll and test animals
B. CHALLENGE EXPOSURE
- Hair was removed by clipping from a 50 x 50 mm area on the right flank of each animal.
- A 20 x 20 mm patch of surgical gauze was saturated with ca. 1.5 ml of ethyl cyanoacetate, as supplied
- No. of exposures: 1
-The control and test animals were challenged topically two weeks after the final induction using ethyl cyanoacetate
- Contact of the test substance with the skin was approxitmately 6 hours for each induction exposure
- Evaluation: The challenge sites were evaluated 24, 48 and 72 hours after removal of the patches
All animals were observed daily for signs of ill health or toxicity.
The body weight of the animals were recorded on day 1 and on the last day of the observation. - Positive control substance(s):
- yes
- Remarks:
- formalin
Results and discussion
- Positive control results:
- The sensitivity of the guinea pig strain used is checked periodically with formalin, a known sensitiser. All animals showed dermal reactions.
Any other information on results incl. tables
Clinical signs: No sogns of ill health or toxicity were recorded
Bodyweight: The bodyweight of all guinea pigs increased in a normal way over the period of the study.
Induction: There were no dermal reactions seen in any of the test or control animals.
Challenge:
The "Buehler test" of E.V. Buehler was performed to reveal a possible sensitising potential of
"Ro 1525". Investigations performed were in conformance with EPA OTS 798.4100. Ten female guinea pigs were used as a test substance group and another 10 females were used as a negative control group. There were three epicutaneous induction exposures and one epicutaneous challenge exposure. The test substance was used undiluted for all three induction exposures and for the challenge exposure. The areas of administration were covered occlusive for 6 hours.
General:
All animals survived till the end of the study. No ill health or toxicity effects were noted.
Skin reactions after induction exposures:
The application sites of all control animals were normal at each time.
There were no dermal reactions seen in any of the test or control animals.
Skin reactions after challenge exposure :
There were no dermal reactions seen in any of the test or control animals.
According to the EC Guideline 93/21 the test substance Ethyl cyanoacetate is not sensitising.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Classification: not sensitizing
Neither in the induction nor in the challenge no dermal reactions were seen in any of the test or control animals.
According to the EC Guideline 93/21 the test substance Ethyl cyanoacetate is not sensitising. - Executive summary:
The "Buehler test" of E.V. Buehler was performed to reveal a possible sensitising potential of Ethyl cyanoacetate. Investigations performed were in conformance with EPA OTS 798.4100. Ten female guinea pigs were used as a test substance group and another 10 females were used as a negative control group. There were three epicutaneous induction exposures and one epicutaneous challenge exposure. The test substance was used undiluted for all three induction exposures and for the challenge exposure. The areas of administration were covered occlusive for 6 hours.
General:
All animals survived till the end of the study. No ill health or toxicity effects were noted.
Skin reactions after induction exposures:
The application sites of all control animals were normal at each time.
There were no dermal reactions seen in any of the test or control animals.
Skin reactions after challenge exposure:
There were no dermal reactions seen in any of the test or control animals.
According to the EC Guideline 93/21 the test substance Ethyl cyanoacetate is not sensitising.
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