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EC number: 932-389-6 | CAS number: -
- 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
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study under GLP with acceptable restrictions.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- LLNA method was not available by the time the study was conducted.
- Species:
- guinea pig
- Strain:
- other: Alderley Park, SPF-derived albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Animal Breeding Unit, ICI Limited, Pharmaceuticals Division, Alderley Park, Macclesfield, Cheshire
- Age at study initiation: 21-42 d
- Weight at study initiation: 300-400 g
- Housing: individually in solid-bottom plastic cages with sawdust bedding
- Diet (e.g. ad libitum): Frant FDI guinea pig diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: minimum six days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22°C
- Humidity (%): 50-60%
- Air changes (per hr): 24 - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Dose finder: 100%, 75%, 50%, and 25% (w/v)
Main test (challenge): 75% and 50% (w/v) - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- Dose finder: 100%, 75%, 50%, and 25% (w/v)
Main test (challenge): 75% and 50% (w/v) - No. of animals per dose:
- Control animals: 10
Test animals: 10 - Details on study design:
- RANGE FINDING TESTS: yes, with 100%, 75%, 50%, and 25% (w/v) in corn oil
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 3 weeks
- Test groups: 10 animals
- Control group: 10 animals
- Site: scapular region
- Duration: 6 h
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 2 weeks after last induction exposure
- Exposure period: 6 h
- Test groups: 10 animals
- Control group: 10 animals
- Site: flank
- Evaluation (hr after challenge): 24 and 48 h - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- faint erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: faint erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- faint erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 75%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: faint erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- faint erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 5.0. Total no. in groups: 10.0. Clinical observations: faint erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- faint erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: faint erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: vehicle control
- Dose level:
- 0%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- faint erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: vehicle control. Dose level: 0%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: faint erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: vehicle control
- Dose level:
- 0%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- faint erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: vehicle control. Dose level: 0%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: faint erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- Cyhalothrin is a skin sensitizer under the conditions of the study described.
- Executive summary:
Skin sensitizing potential of Cyhalothrin was assessed using the Buehler test on guinea pigs. GLP compliance was stated.
The test item Cyhalothrin Challenge of test and control animals with a 50% solution of cyhalothrin in corn oil caused faint erythema in 5 out of 10 test animals 24 h after challenge. This erythema persisted in one animal at 48h after challenge. Challenge with a 75% solution in corn oil caused faint erythema in 2 out of 10 test animals 24 h after challenge. This erythema persisted in one animal at 48h after challenge. No erythema were observed in any control animal.
Based upon the classification criteria according to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, the test item has to be classified as skin sensitizer on the basis of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitizing potential of the substance was assessed using the Buehler test on guinea pigs. GLP compliance was stated.
The test item Cyhalothrin Challenge of test and control animals with a 50% solution of cyhalothrin in corn oil caused faint erythema in 5 out of 10 test animals 24 h after challenge. This erythema persisted in one animal at 48h after challenge. Challenge with a 75% solution in corn oil caused faint erythema in 2 out of 10 test animals 24 h after challenge. This erythema persisted in one animal at 48h after challenge. No erythema were observed in any control animal.
Justification for classification or non-classification
The available data on Skin sensitization is considered reliable with restrictions but adequate for the classification and labelling.
Based upon the classification criteria according to the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008, the test item has to be classified as skin sensitizer on the basis of this study.
According to the criteria in Directive 2001/59/EC, Annex VI, 3.2, the substance is classified as R43, May cause skin sensitization by skin contact.
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