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Diss Factsheets
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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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP LAB testing
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4100 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- 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:
- Purity: 99.7%
Appearance: Clear liquid
Storage conditions: Room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- Twenty healthy female nulliparous and non-pregnant albino guinea-pigs of the Dunkin/Hartley strain were obtained.
The animals were in the weight range of 320 to 377 g on arrival and approximately six to seven weeks of age. All the guinea-pigs were acclimatised to the experimental environment for 6 days prior to allocation to the main study.
An additional three animals, from the same supplier, were used for the preliminary investigations. The animals for the main study were allocated without conscious bias to two groups as follows:
The guinea-pigs were housed in groups of five in suspended metal cages with wire mesh floors in Building R 17 Room 14.
A vitamin C enriched guinea-pig diet FD I and drinking water were provided ad libitum. Hay was given weekly.
The batch of diet used for the study was not analysed for nutrients, possible contaminants or micro organisms.
Results of routine physical and chemical examination of drinking water at source, as conducted usually weekly by the supplier, are made available to Huntingdon Research Centre Ltd. as quarterly summaries.
Animal room temperature was maintained at approximately 21 oc and relative humidity at 30 - 70%. These environmental parameters were recorded daily. Air exchange was maintained at approximately 15 air changes per hour and lighting was controlled by means of a time switch to give 12 hours of artificial light (0700- 1900 hours) in each 24 hours period.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- no data
- Concentration / amount:
- 0.5 ml
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- no data
- Concentration / amount:
- 0.5 ml
- No. of animals per dose:
- 10
- Details on study design:
- The procedure may be considered in two parts, Induction and Challenge.
Induction - test animals
Prior to each induction application, the skin on the left shoulder region of the guinea-pig was clipped free of hair using electric clippers.
A 20 x 20 mm patch of surgical gauze (three layers thick) was saturated with approximately 0.5 ml of Ethyl cyanoacetate (ECYAD), as supplied.
The patch was placed on the skin and covered by a length of impermeable plastic adhesive tape (50 mm width "Blenderm"). This in turn was firmly secured by elastic adhesive bandage (50 mm width "Elastoplast") wound round the torso of the animal and fixed with "Sleek" impervious plastic adhesive tape. Contact with the skin was maintained for approximately 6 hours for each induction exposure. The dressings were then removed and the resulting dermal reactions assessed approximately 24 hours later (Table 1).
One induction application was made in this manner on Days 1, 8 and 15 so a total of three induction applications were given.
Induction- control animals
During the induction phase, the control animals were treated similarly to the test animals with the exception that the test compound was omitted from the induction applications.
The dermal reactions observed approximately 24 hours after each induction application in both control and test animals were recorded.
Challenge - control and test animals
The control and test animals were challenged topically two weeks after the final induction application using Ethyl cyanoacetate (ECY AD), as supplied.
Hair was removed by clipping from a 50 x 50 mm area on the right flank of each guinea-pig. A 20 x 20 mm gauze patch (three layers thick) was saturated with approximately 0.5 ml of the test substance in a similar fashion to that used for the induction applications.
The patch was sealed to the flank under a 5 em strip of "Blenderm" covered by "Elastoplast" wound round the trunk and secured with "Sleek". Dressings were left in place for approximately 6 hours after which time they were removed. - Challenge controls:
- The control and test animals were challenged topically two weeks after the final induction application using Ethyl cyanoacetate (ECY AD), as supplied.
- Positive control substance(s):
- yes
- Remarks:
- formalin
Results and discussion
- Positive control results:
- The sensitivity of the guinea-pig strain used is checked periodically at HRC with formalin, a known sensitiser. All results of recent tests showed reaction.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 0.5ml
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 0.5ml. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 15%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: positive control. Dose level: 15%. No with. + reactions: 10.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Guinea-pignumber |
E=Erythema0=Oedema |
Response toinductionapplications |
||
1 2 3 |
||||
4750 |
E 0 |
0 0 |
0 0 |
0 0 |
4751 |
E 0 |
0 0 |
0 0 |
0 0 |
4752 |
E 0 |
0 0 |
0 0 |
0 0 |
4753 |
E 0 |
0 0 |
0 0 |
0 0 |
4754 |
E 0 |
0 0 |
0 0 |
0 0 |
4755 |
E 0 |
0 0 |
0 0 |
0 0 |
4756 |
E 0 |
0 0 |
0 0 |
0 0 |
4757 |
E 0 |
0 0 |
0 0 |
0 0 |
4758 |
E 0 |
0 0 |
0 0 |
0 0 |
4759 |
E 0 |
0 0 |
0 0 |
0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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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