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EC number: 266-719-9 | CAS number: 67564-91-4
- 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
Fenpropimorph did not show skin sensitizing properties in a GLP conform guinea pig maximization test according to OECD guideline 406.
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:
- 11.2010 - 05.2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 17, 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- certified by Behörde für Soziales, Familie, Gesundheit und Verbraucherschutz, Hamburg
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- According to OECD guideline 429, the LLNA test is not suitable for the test substance since false positive findings with certain skin irritants interfere with the accuracy of the method.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Stolzenseeweg 32 – 36, 88353 Kißlegg, Germany
- Age at study initiation: 30-32 days
- Weight at study initiation: 325-381 g (test group); 312-365 g (positive reference group)
- Housing: in pairs
- Diet: ssniff® Ms-H V2233, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: At least 5 days
- Indication of any skin lesions: Animals even if only slightly injured by shaving were replaced
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C ± 3°C
- Humidity: 55% ± 15%
- Air changes (per hr): not specified
- Photoperiod: 12-hour light / 12-hour dark
IN-LIFE DATES:
From: 2010-11-03
To: 2011-04-09 - Route:
- intradermal
- Vehicle:
- other: Aqua ad iniectabilia
- Concentration / amount:
- 5% suspension
- Day(s)/duration:
- Study day 0, single injection
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Aqua ad iniectabilia
- Concentration / amount:
- 25 % suspension
- Day(s)/duration:
- Study day 7, exposure period: 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Aqua ad iniectabilia
- Concentration / amount:
- 10 % suspension
- Day(s)/duration:
- Study day 21, exposure period: 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Preliminary study: 2 animals (0.01, 0.1, 0.5, 1, 5 or 10 % suspension by intracutaneous application); 3 animals (10, 25, 50 and 75 % suspension by topical administration)
Main experiment: 20 animals (5 % suspension by intracutaneous injection; 10 % and 25 % suspension by topical administration); 10 animals (vehicle control); 20 animals (positive control from a historical background group from a study performed during October 2010) - Details on study design:
- RANGE FINDING TESTS: yes
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 pairs of intracutaneous injections; 1 topical application
- Exposure period: 48 hours
- Test groups: yes
- Control group: vehicle control was conducted; positive control from historical data
- Site: shoulder region (intracutaneous); shoulder region (topical)
- Frequency of applications: 3 consecutive pairs of intracutaneous injections; 1 single topical application
- Duration: Study day 0 and 7
- Concentrations: 5 % and 25 % in aqua ad iniectabilia
B. CHALLENGE EXPOSURE
- No. of exposures: 1 topical application
- Day(s) of challenge: Study day 21
- Exposure period: 24 hours
- Test groups: yes
- Control group: vehicle control was conducted; positive control from historical data
- Site: flank region (topical)
- Concentrations: 10 % in aqua ad iniectabilia
- Evaluation: 48 and 72 hours - Positive control substance(s):
- yes
- Remarks:
- - not concurrently conducted - 10% (v/v) α-hexyl cinnamic aldehyde solution intracutaneously in stage 1, - undiluted α-hexyl cinnamic aldehyde topically in stage 2 - 0.01% α-hexyl cinnamic aldehyde solution in stage 3
- Positive control results:
- Animals of this strain treated with 0.01% α-hexyl cinnamic aldehyde in sesame oil exhibited a sensitizing reaction in all animals in form of a discrete or patchy erythema (grade 1).
- Group:
- negative control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.01% α-hexyl cinnamic aldehyde solution
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Discrete or patchy erythema on the left flank and no visible change on the right flank of all animals.
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The positive control group was not tested concurrently with this study but is a historical background group from a study performed during October 2010.
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- positive control
- Dose level:
- 0.01% α-hexyl cinnamic aldehyde solution
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Clinical observations:
- Discrete or patchy erythema on the left flank and no visible change on the right flank of all animals.
- Remarks on result:
- positive indication of skin sensitisation
- Remarks:
- The positive control group was not tested concurrently with this study but is a historical background group from a study performed during October 2010.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- other: vehicle control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- other: vehicle control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin irritation in any animal
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no skin irritation in any animal
- Remarks on result:
- no indication of skin sensitisation
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
Fenpropimorph does not need to be classified for skin sensitizing properties according to EC/1272/2008.
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