Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-767-1 | CAS number: 110-43-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study is an OECD guideline study conducted under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Heptan-2-one
- EC Number:
- 203-767-1
- EC Name:
- Heptan-2-one
- Cas Number:
- 110-43-0
- Molecular formula:
- C7H14O
- IUPAC Name:
- heptan-2-one
- Reference substance name:
- Methyl n-amyl ketone
- IUPAC Name:
- Methyl n-amyl ketone
- Details on test material:
- Description pale yellow liquid
Batch number TD-9024390
Purity 99.63%
Date received 01 November 2010
Expiry date 01 November 2011
Storage conditions room temperature in the dark
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three New Zealand White (Hsdlf:NZW) strain rabbits were supplied by Harlan Laboratories U.K. Ltd., Loughborough, UK. At the start of the study the animals weighed 2.21 or 2.49 kg and were twelve to twenty weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended cages. Free access to mains drinking water and food (2930 Teklad Global Rabbit diet supplied by Harlan Laboratories U.K. Ltd., Oxon, UK) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected thepurpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 17 to 23°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- One rabbit was initially treated. Three suitable sites were selected on the back of the rabbit. A quantity of 0.5 ml of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm cotton gauze patch. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset for the duration of the exposure period. One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application. Any residual test item was removed by gentle swabbing with cotton wool soaked in distilled water. After consideration of the skin reactions produced in the first animal, an additional two animals were treated with 0.5 ml of test item. One patch was applied to the back of each rabbit and was allowed to remain in contact with the skin for a period of four hours. Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored
- Duration of treatment / exposure:
- 3 minutes, 1 hour and 4 hours on the initial animal, followed by 4 hours on the remaining animals
- Observation period:
- 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- Animals were treated with the test article under a semi-occlusive patch for 4 hours. At the end of the exposure period, the treatement sites were washed with distilled water and observed for irritation for 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 4 hours
- Score:
- ca. 3.7
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.6
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Reversibility:
- fully reversible
Any other information on results incl. tables
Skin Reaction | Observation Time (following patch removal) | Individual Scores - Rabbit Number and Sex | |
69775 Male | |||
3-Minute Exposure | 1-Hour Exposure | ||
Erythema/Eschar Formation |
Immediately 1 Hour 24 Hours 48 Hours 72 Hours 7 Days 14 Days |
0 0 2 2 2 0D 0D |
2 2 2Br 2BrLe 2BrLe 0D 0D |
Oedema Formation | Immediately 1 Hour 24 Hours 48 Hours 72 Hours 7 Days 14 Days |
0 0 1 1 1 0 0 |
1 1 1 1 1 0 0 |
D= Slight desquamation, Br = Light brown discoloration of the epimermis, Le = Loss of skin elasticity |
Individual Skin Reactions Following 4-Hour Exposure | |||||
Skin Reaction | Observation Time (following patch removal) | Individual Scores- Rabbit Number and Sex | Total | ||
69775 Male | 69835 Male | 70023 Male | |||
Erythema/Eschar Formation |
Immediately 1 Hour 24 Hours 48 Hours 72 Hours 7 Days 14 Days |
2 2 2BrLe 2BrLe 2BrLelf ?eCf OD |
0 0 2 2 2 OD - |
0 0 2 2 2 OD - |
( 2 ) ( 2) 6 ( 6 ) 6 ( 0-4) ( 0 ) |
Oedema Formation |
Immediately 1 Hour 24 Hours 48 Hours 72 Hours 7 Days 14 Days |
2 2 2 2 2 ?od 0 |
0 0 1 2 2 0 - |
0 0 2 1 1 0 - |
( 2 ) ( 2 ) 5 ( 5 ) 5 ( 0-4) ( 0 ) |
Sum of 24 and 72-hour Readings (S) 22 | |||||
Primary Irritation Index (S/6) 22/6 = 3.7 | |||||
Classification MODERATE IRRITANT | |||||
( ) = total values not for calculation of primary irritation index, Lf - loss of skin flexability, Cf = crust formation, | |||||
D = slight desquamation, ?e = adverse reactions prevented accurate evaluation of erythema, | |||||
?od = adverse reactions prevented accurate evaluation of edema, -= observation not required |
Applicant's summary and conclusion
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test item produced a primary irritation index of 3.7 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.
- Executive summary:
The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White rabbit. The method was designed to be compatible with OECD and EU commission guidelines. Test animals had 0.5 ml aliquots of stock test article applied to shorn patches of skin and covered with an occlusive dressing for 4 hours. After treatment , the test article was washed away and the animals were observed for 72 hours. A single 4-hour, semi-occluded application of the test item to the intact skin of three rabbits produced well-defined erythema and slight oedema. Other signs of skin irritation noted were light brown discolouration of the epidermis, loss of skin flexibility and/or elasticity, crust formation and slight desquamation. The test item produced a primary irritation index of 3.7 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.