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EC number: 224-623-4 | CAS number: 4430-31-3
- 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:
- 03 December, 1979 - 06 February, 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been followed but not GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- (1981)
- Deviations:
- yes
- Remarks:
- no details on purity, no details on animal housing and environmental conditions
- GLP compliance:
- no
Test material
- Reference substance name:
- Octahydro-2H-1-benzopyran-2-one
- EC Number:
- 224-623-4
- EC Name:
- Octahydro-2H-1-benzopyran-2-one
- Cas Number:
- 4430-31-3
- Molecular formula:
- C9H14O2
- IUPAC Name:
- octahydro-2H-1-benzopyran-2-one
- Test material form:
- liquid
1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 9 - 12 weeks
- Animals in the telogen phase of hair growth were selected.
ENVIRONMENTAL CONDITIONS
No data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent areas of the untreated skin of each animal served as controls.
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48 and 72 hours
- Number of animals:
- 8
- Details on study design:
- TEST SITE:
The whole dorsal surface was clipped 3-4 days before application of the test substance.
TREATMENT
Occlusive patches were prepared by attaching a piece of thin flexible polythene (3 cm x 3 cm) to a piece of zinc oxide plaster 9 cm x 2.5 cm. A 2.5 cm square of cotton gaue was laid on the polythene such that the edges of the patch were attached to the zinc oxide plaster. The undiluted test substance was applied to a dry patch. The patches were firmly attached to ensure good contact between the skin and test substance. The animals were immobilised in a canvas body sleeve for 4 hours after application of the patch.
REMOVAL OF TEST SUBSTANCE
Four hours after the application, the patches were removed and the skin are wiped clean of excess material.
OBSERVATIONS
- Mortality/Viability and Clinical signs: Daily
- Body Weight: At the start of acclimatization, day 1 (application day) and at termination (day 15)
- Irritation: The skin sites were assessed for irritation immediately after treatment, and at 24, 48 and 72 hours. The irritation scores and a description of all other (local) effects were recorded.
SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404 (1981).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 12
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 12
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal:
- Remarks:
- #3 and #8
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal:
- Remarks:
- #4 and #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 12
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal:
- Remarks:
- #7
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 12
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 12
- Irritation parameter:
- edema score
- Basis:
- animal: #3 and #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 12
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 12
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal: #7
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 12
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal: #8
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 12
- Reversibility:
- not fully reversible within: 72 hours
- Irritant / corrosive response data:
- Reaction grades erythema 72 hours after treatment: three animals marginal/very slight and five animals no effects observed. Reaction grades oedema 72 hours after treatment: three animals marginal/very slight and five animals no effects observed. Six animals showed also marginal/very slight cracking and two animals showed marginal/ very slight scaling, 2 animals showed no cracking/scaling. No results on the reversibility as the observation period was not extended to 7 days.
- Other effects:
- - No mortality occurred
Any other information on results incl. tables
Skin irritation response data (for the undiluted test substance)
Observation time | 24 hours | 48 hours | 72 hours | |||
Animal no.: | erythema | oedema | erythema | oedema | erythema | oedema |
1 | - | 1 | - | - | - | 1 |
2 | 1 | - | - | - | - | - |
3 | 1 | 1 | 1 | - | 1 | - |
4 | 2 | 2 | - | - | - | - |
5 | 3 | 2 | 1 | 1 | 1 | 1 |
6 | 2 | 1 | - | - | - | - |
7 | 2 | 1 | 1 | 1 | - | - |
8 | 1 | 1 | 1 | 1 | 1 | 1 |
1 = marginal/very slight
2 = slight
3 = fairly distinct
4 = quite distinct
6 = becoming well developed
8 = well developed
10= becoming severe
12= severe
Applicant's summary and conclusion
- Interpretation of results:
- other: Not a skin irritant.
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its amendments
- Conclusions:
- In a skin irritation study with rabbits, performed equivalent to OECD 404 guideline, limited irritation was observed. As the substance showed marginal /very slight irritating to skin 72 hours after treatment and the symptoms were less than 24 and 48 after treatment, the substance does not have to be classified for skin irritation.
- Executive summary:
The substance was tested in 8 rabbits in a skin irritation test equivalent to OECD TG 404 test guideline.Reaction grades of erythema 72 hours after treatment showed three animals with marginal/very slight whereas five animals showed no effects. Reaction grades of oedema 72 hours after treatment showed three animals with marginal/very slight and five animals showed no effects. No results on the reversibility as the observation period was not extended to 7 days. As the substance showed marginal /very slight irritating to skin 72 hours after treatment and the symptoms were less than 24 and 48 after treatment, the substance does not have to be classified for skin irritation.
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