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EC number: 412-280-5 | CAS number: 2511-00-4 POIRENATE
- 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:
- From 5 November 1991 to 16 November 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to the method B.4 Part B and it is GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Ethyl 2-cyclohexylpropionate
- EC Number:
- 412-280-5
- EC Name:
- Ethyl 2-cyclohexylpropionate
- Cas Number:
- 2511-00-4
- Molecular formula:
- C11H20O2
- IUPAC Name:
- ethyl 2-cyclohexylpropanoate
- Details on test material:
- - Physical state: clear liquid
- Storage condition of test material: 4ºC in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Froxfield (U.K) Ltd., Petersfield, Hampshire, England
- Age at study initiation: 13/15 weeks
- Weight at study initiation: 2.6-3.0 kg
- Housing: individually in metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12-12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL amount of the test substance
- Duration of treatment / exposure:
- Examination of the treated skin was made on Day 1 (approximately 30 minutes after removal of the dressings) and on Days 2, 3 and 4 (equivalent to 24 and 48 and 72 after exposure). additional observation were made on Days 5 to 12.
- Observation period:
- 12 days
- Number of animals:
- Three healthy adults
- Details on study design:
- TEST SITE
- Area of exposure: 25mm x 25mm
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water to remove any residual test substance
SCORING SYSTEM:
Local dermal irritation was assessed using the prescribed numerical system:
Erythema and eschar formation:
No erythema: 0
Very slight erythema (barely perceptible): 1
Well-defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Oedema formation:
No oedema: 0
Very slight oedema (barely perceptible): 1
Slight oedema (edges of area well-defined by definite raising): 2
Moderate oedema (raised approximately 1 millimetre): 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure): 4
Any other lesion not covered by this scoring system, was described.
Results and discussion
In vivo
- Irritant / corrosive response data:
- CLINICAL SIGNS
There were no signs of toxicity or ill health in any rabbit during the obervation period.
DERMAL RESPONSES
The numerical values given to the dermal reactions elicited by the test substance are in the Table 1. Very slight erythema with very slight to slight oedema was observed in all three animals, Welldefined erythema was seen in one animal on Day 3 only. Desquamation of the stratum corneum (sloughing) was seen in all three animals, in two from Day 7-11 and in one on Days 10 and 11 only.
Any other information on results incl. tables
Table 1: Dermal reactions observed after application of the test substance
Rabbit number and sex | E= Erythema O= Oedema |
Day | |||||||||||
1* | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | ||
1912 Female | E | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1A | 0A | 0 |
O | 1 | 2 | 1 | 1 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | |
1913 Female | E | 1 | 1 | 1 | 1 | 1 | 1 | 1A | 1A | 0A | 0A | 0A | 0 |
O | 1 | 1 | 1 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | |
1914 Female | E | 1 | 1 | 2 | 1 | 1 | 1 | 1A | 0A | 0A | 0A | 0A | 0 |
O | 1 | 2 | 2 | 1 | 1 | 1 | 1 | 0 | 0 | 0 | 0 | 0 |
A Sloughing of epidermis
*Approximately 30 minutes after removal of the dressing
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A single semi-occlusive application of the test substance to intact rabbit skin for four hours elicited slight to well-defined dermal reactions. All reactions had solved by Day 12.
- Executive summary:
A study was performed to assess the skin irritation potential of the test substance to the rabbit. The method followed was that described in the method B.4 Part B. Three rabbits were each administered a single dermal dose of 0.5mL of the test substance and observed for a maximim of 12 days. A single semi-occlusive application of the test substance to intact rabbit skin for four hours elicited slight to well-defined dermal reactions. All reactions had resolved by Day 12. The test substance does not require labelling with the risk phrase R38 "Irritating to skin" in accordance with EEC Council Direcitve 79/831/EEC, Annex VI, Part II (D) as described in Commission Directive 91/325/EEC.
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