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EC number: 604-636-5 | CAS number: 148477-71-8
- 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:
- 15 March 1996 - 25 September 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EEC B.4.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-(3,5-Dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate
- Cas Number:
- 148477-71-8
- Molecular formula:
- C21H24Cl2O4
- IUPAC Name:
- 3-(3,5-Dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4-yl 2,2-dimethylbutanoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Leuschner, Germany
- Age at study initiation: ~5 months
- Weight at study initiation: 1.9-2.0 kg
- Housing: singly
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 30-70
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 21 March 1996 To: 24 March 1996
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- 500 mg (moistened with water)
- Duration of treatment / exposure:
- The duration of exposure was 4 hours
- Observation period:
- Skin irritation was assessed at 1-, 24-, 48-, 72 hours after exposure.
- Number of animals:
- 3 Rabbits were used in the study
- Details on study design:
- 500 mg spirodiclofen was moistened with water, applied to the test site and covered with a gauze patch to the skin (area: approx. 6 cm²). The patch was held in contact with the skin by a semi-occlusive dressing. The duration of exposure was 4 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritating effects.
- Remarks on result:
- no indication of irritation
- Remarks:
- None of the rabbits showed irritation at 24, 48 or 72 hours
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no irritating effects
- Remarks on result:
- no indication of irritation
- Remarks:
- None of the rabbits showed irritation at 24, 48 or 72 hours
- Irritant / corrosive response data:
- Not applicable: there were no signs of irritation at any time point
Any other information on results incl. tables
Skin irritation scores:
1h | 1h | 24h | 24h | 48h | 48h | 72h | 72h | 7d | 7d | 14d | 14d | Irrit. Index | Irrit. Index | |
Animal No. | e | oe | e | oe | e | oe | e | oe | e | oe | e | oe | e | oe |
1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | - | - | - | 0.0 | 0.0 |
2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | - | - | - | 0.0 | 0.0 |
3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | - | - | - | - | 0.0 | 0.0 |
0 = no pathological findings; - = not examined; d = day; e = erythema and eschar formation; h = hour, -s;
oe = oedema formation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Spirodiclofen is not classified as a skin irritant according to the CLP criteria, on the basis of this study.
- Conclusions:
- There was no evidence of skin irritation in this study.
- Executive summary:
The skin irritation/corrosion potential of spirodiclofen was investigated in a study in three rabbits, performed according to OECD 404. The study predates the adoption of in vitro tests for the assessment of skin corrosion and skin irritation. 0.5 g of spirodiclofen (moistened with water) was applied for fhour hours under occlusive conditions to the shorn skin of three Himalayan rabbits. Local dermal reactions were scored at 24, 48 and 72 hours after application, using the Driaze scale. There were no signs of irritation in any rabbit at any time point. Spirodiclofen is not classified as a skin irritant according to the CLP criteria, on the basis of this study.
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