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Diss Factsheets
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EC number: 915-768-0 | 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 August to 25 August 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- 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)
Test material
- Reference substance name:
- Ethyl 2-ethyl-6,6-dimethylcyclohex-2-ene-1-carboxylate
- EC Number:
- 261-020-5
- EC Name:
- Ethyl 2-ethyl-6,6-dimethylcyclohex-2-ene-1-carboxylate
- Cas Number:
- 57934-97-1
- Molecular formula:
- C13H22O2
- IUPAC Name:
- ethyl 2-ethyl-6,6-dimethylcyclohex-2-ene-1-carboxylate
- Reference substance name:
- Ethyl 2,3,6,6-tetramethylcyclohex-2-ene-1-carboxylate
- EC Number:
- 278-776-7
- EC Name:
- Ethyl 2,3,6,6-tetramethylcyclohex-2-ene-1-carboxylate
- Cas Number:
- 77851-07-1
- Molecular formula:
- C13H22O2
- IUPAC Name:
- ethyl 2,3,6,6-tetramethylcyclohex-2-ene-1-carboxylate
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- Test material (as stated in report): Givescone
Batch No.: 9000375280
Colourless to pale yellow liquid
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Age at start of treatment 15 weeks (male) and 14 to 15 weeks for (females).
Body weighs at start of treatment 2.8 to 3.0 Kg
Accommodation: individually in stainless steel cages equipped with feed hoppers, drinking water bowls
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml of Givescone undiluted
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 and 72 hours as well as 7 and 10 days after removal of the dressing, gauze patch and test item.
- Number of animals:
- 1 male and 2 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 67
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 68
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- animal: 69
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: 67
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal: 68
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: 69
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. Well defined erythema was observed in all animals at the 1 -hour reading and decreased in severity in one animal at 24 hours, in another at 48 hours and in the third animal 72 hours befoer disappearing at day 7 in all animals. Very slight oedema was noted in all animals at the 1 -hour reading and persisted in one animal through to 72 hours. Slight scaling was observed in all animals at 7 days.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Givescone is considered to be not irritating to rabbit skin in this test conditions and does not meet the GHS criteria for skin irritation classification.
- Executive summary:
The primary skin irritation potential of GIVESCONE was investigated by topical semi occlusive application of 0.5 ml to 6 cm2 intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was paerformed 1, 24, 48 and 72 hours, as well as 7 and 10 days after removal of dressing. The scores of each animal at the following reading times (24, 48 and 72 hours) were used on calculating the respective mean values for each type of lesion.
Local signs (mean values from 24 to 72 hours) consisted of grade 1.33 erythema and grade 0.33 oedema.
Well defined erythema was observed in all animals at the 1 -hour reading and decreased in severity in one animal at 24 hours, in another at 48 hours and in the third animal 72 hours befoer disappearing at day 7 in all animals. Very slight oedema was noted in all animals at the 1 -hour reading and persisted in one animal through to 72 hours. Slight scaling was observed in all animals at 7 days.
The test item caused no staining of the treated skin. No corrosive effects were notes on the treated skin of any animal at any measuring interval.
Based upon the referred GHS classification criteria, Givescone is to be not irrittating to rabbit skin.
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