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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Endpoint summary
Administrative data
Description of key information
In vitro/in chemico data are not available; the available in vivo study predates the adoption of validated test in vitro test methods for skin sensitisation.
A guinea pig Maximisation tes (GLP, OECD 406) is available for spirodiclofen.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- In-life initiated/completed: 25-June-1996 to 26-July-1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- not specified
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- Previously known as EEC B.6.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed to the OECD test guideline (OECD 406) in place at the time (1996), and therefore predates the adoption of the LLNA (OECD 429) in 2002. The study is scientifically valid and adequate for hazard assessment and classification purposes.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Hsd PoC:DH
- Sex:
- female
- Details on test animals and environmental conditions:
- A total of 25 female animals were used in the study, including those employed in the range-finding tests to determine the induction and challenge concentrations.
Acclimatisation: Following receipt, the animals scheduled for this study were adapted to the maintenance conditions for a period of at least seven days before treatment, and their state of health was monitored.
State of health: Only healthy animals exhibiting no clinical signs were used for the study. The animals were not vaccinated or treated against infections either before receipt, or during the adaptation or study periods. The females were nulliparous and non-pregnant.
Age and body weight: The guinea pigs exhibited a mean weight of 288-295 grams at the beginning of the study. This weight corresponds to an age of 5 - 7 weeks.
During the adaptation and study period the animals were conventionally kept in type IV Makrolon® cages [4], in groups of five during the adaptation period and in groups of two or three per cage throughout the study period. The cages were exchanged for ones with clean bedding two times per week. Low-dust wood shavings were used as bedding. The wood shavings were spotchecked for contaminant levels. Records of these test results are filed at BAYER AG. The analytical results provided no evidence for an effect on the study objective. All animals used in this study were kept in the same animal room, one in which guinea pigs from other sensitization studies were also housed. Adequate separation, unambiguous cage markings and suitable organization of the work ensured that animals were not mixed up.
The animal room was swept out with a broom each day, and thoroughly cleaned with water once weekly. The room was disinfected at least once each month with Zephirol® 10% (10 grams benzalkonium chloride per 100 grams disinfectant; working dilution 2%, corresponding to 20 ml per liter of water). Contamination of the diet and contact with the experimental animals were avoided during this work. No pest control measures were carried out in the animal rooms. KILLIGERM Roach Traps ®, a cockroach trap which uses no pesticides, was placed in the animal room from July 10, 1996.
Diet: The diet consisted of "Altromin®3020 - Maintenance Diet for Guinea Pigs" and of tap water. Food and water were provided ad libitum.
Climatic Conditions:
Room temperature: 22 +/- 3°C (possibly drifting higher at outdoor temperatures above 24°C)
Relative humidity: 40 - 60 %
Light/dark cycle: Twelve hours; artificial lighting from 6 AM to 6 PM CET
Air exchange rate: >= 10 times per hour
Occasional deviations from these standards occurred at times including the period following the cleaning of the animal room. They had no apparent effect in the course of the study. - Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- 0.5 ml Spirodiclofen 50% in physiological saline solution containing 2% Cremophor EL®
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- other: Performed one week after intradermal induction.
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- No test substance used - complete Freund's adjuvant only
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- 5% Spirodiclofen formulated in physiological saline solution containing 2% Cremophor EL®
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- physiological saline
- Remarks:
- and complete Freund's adjuvant.
- Concentration / amount:
- 5% Spirodiclofen formulated at equal parts in sterile physiological saline solution and
complete Freund's adjuvant. - Adequacy of induction:
- not specified
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 50% test substance formulation - The volume applied in each case was 0.5 ml. shaved right flank of the animals is where the test substance was applied.
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- not specified
- Concentration / amount:
- 50% test substance formulation - The volume applied in each case was 0.5 ml. shaved left flank of the animals is where the test substance was applied.
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 10 animals in main study group, 5 in the control group and 5 in the dose range-finding group.
- Details on study design:
- The test substance was formulated in sterile physiological saline solution containing 2% Cremophor EL to yield a suspension. A 5% concentration was used for intradermal, and a 50% concentration for topical induction. A 50% concentration was used for the first and second challenge.
- Challenge controls:
- Yes - a 50% formulated substance of the test material was used for both Challenges.
- Positive control substance(s):
- no
- Positive control results:
- N/A
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- NA
- Clinical observations:
- NA
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- NA
- Clinical observations:
- NA
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 50% test substance formulation
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% test substance formulation
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- Vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- Vehicle only
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Spirodiclofen showed evidence of skin sensitisation potential under the conditions of this study.
- Executive summary:
The skin sensitisation potential of spirodiclofen was investigated in a Guinea Pig Maximization Test (GPMT) using female Dunkin-Hartley guinea pigs. The study was conducted using concentrations of 5% for intradermal induction and 50% for topical induction. Two challenge applications were made, using 50% test material. The test material was formulated in physiological saline solution containing 2% Cremophor EL to yield a suspension. The first and the second challenge resulted in skin reactions in 4 of 10 (40%) animals in the test group and 0 of 10 animals in the control group. However, only one animal showed a positive reaction in both challenge treatments. Spirodiclofen showed evidence of skin sensitisation potential under the conditions of this study, and requires classification as a skin sensitiser (Cat 1B) according to the CLP criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No data are available; there is no evidence or structural alerts raising concerns that spirodiclofen is a respiratory sensitiser.
Justification for classification or non-classification
The results of the Maximisation assay with spirodiclofen demonstrate skin sensitisation potential. According to the CLP criteria, classification as a skin sensitiser in Category 1B is appropriate. This is consistent with the harmonised classification and the RAC opinion. RAC noted that the positive response in the Guinea Pig Maximization Test was 40% with an intradermal induction dose of >1%. The data were therefore considered sufficient for sub-classification. The response of 40% animals with positive skin reactions is comparably low at such a high intradermal induction dose of 5%. RAC concluded that classification of spirodiclofen for skin sensitisation in Cat 1B was appropriate.
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.