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EC number: 201-126-0 | CAS number: 78-59-1
- 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
Endpoint summary
Administrative data
Description of key information
The test subststance is an eye irritant and a respiratory irritant but does not irritate the skin.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- purity not reported
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: various breeders
- Weight at study initiation: 2-4 kg
- Housing: individually
- Diet: standard diet, ad libitum
- Water: ad libitum - Type of coverage:
- other: occlusive and semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- up to 4 hours
- Observation period:
- The results were assessed 1, 24, 48 and 72 hours and 7 days after removal of the patches
- Number of animals:
- 6 (male and female)
- Details on study design:
- The dorsal and lateral parts of the trunk were shorn 15-24 hours before treatment. 0.5 mL test substance/patch were applied to 3 cm x 3 cm gauze pads. Four samples were attached to the prepared skin areas of each animal: The patches were fixed and covered by wrapping an air-permeable circular bandage (semi-occlusive method) or air-tight plastic foil (occlusive method) around the animals. The local reactions were determined after 1 and 4 hours exposure both under occlusive and semi-occlusive conditions. After removal of the bandages and patches the treated skin areas were rinsed with water and dried.
Skin changes, i.e. erythema and eschar formation, and edema formation were recorded as indicated by the OECD (1981). In addition, special effects were also recorded. The criteria used to define irritation and corrosion were those given in the EEC directive (EEC, 1983). - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: mean
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: 1 and 4 hour exposure, occlusive and semiocclusive conditions
- Other effects:
- No mortality occurred
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: Draize Test according to the US Food and Drug Administration, Federal Register No. 191-11
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: albino
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 mL - Duration of treatment / exposure:
- not rinsed; rinsed after 2 or 4 seconds, or rinsed after 24 hours
- Observation period (in vivo):
- 7 days and later until complete reversibility
- Number of animals or in vitro replicates:
- 3 (6 are rinsed after 24 hours)
- Details on study design:
- Not rinsed / rinsed after 2 seconds / 4 seconds (3 animals each)
Ophtalmoscopic examination after 24, 48, and 72 hours, 4 days, 7 days, and later until complete reversibility. Scoring system: Draize et al. (1944). J Pharmacol Exp Ther 82: 377-390 - Remarks on result:
- other: see 'Irritant/corrosive response data' section for the results
- Irritant / corrosive response data:
- Scores are averages of results after 24, 48, and 72 hours. All effects are reversible.
Not rinsed
- Cornea: 15/80
- Iris: 0/10
- Conjuntivae: 7/20
- Overall irritation score: 22/110
Rinsed after 2 seconds
- Cornea: 21/80
- Iris: 0/10
- Conjuntivae: 6/20
- Overall irritation score: 27/110
Rinsed after 4 seconds
- Cornea: 12/80
- Iris: 0/10
- Conjuntivae: 5/20
- Overall irritation score: 17/110
Rinsed after 24 hours:
- Cornea: 14/80
- Iris: 0/10
- Conjuntivae: 6/20
- Overall irritation score: 20/110 - Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Skin irritation
One guideline study was performed on rabbits with 0.5 mg (corresponds to 1500 mg isophorone/kg bw) and did not result in significant irritancy (Potokar et al., 1985). Only slight irritations were seen after application of 0.5 ml according to a modified Draize protocol (24 hrs exposure) (Dutertre-Catella, 1976). After application of 200 mg/kg isophorone (24 hrs exposure) only slight erythema and desquamation during the first four days after 4 hours of exposure was observed (Esso Research, 1965). The findings were fully reversible.
Eye irritation
Two Draize tests were performed on each 6 male and female rabbits. When applied undiluted to rabbits’ eyes isophorone is moderately to severely irritating to the eyes (Esso Research, 1965; Truhaut et al., 1972). In one study marked irritation was observed which reversed within 14 days but was still present after 7 days (Esso Research, 1965), while in the other study, irritant scores of 14/80 (cornea), 0/10 (iris) and 6/20 (conjunctiva) were reported and had reversed within 7 days (Truhaut et al., 1972).
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for eye irritation cat. 2, H319 under Regulation (EC) No. 1272/2008, as amended for the 14th time in Regulation (EU) 2020/217.
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