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EC number: 266-096-3 | CAS number: 66063-05-6
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984-06-29
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- The most important deviations from the guideline were: no results of a reliability check were provided; no results of the induction application were provided; the dose-selection is unclear
- GLP compliance:
- no
- Remarks:
- Older study, predates mandatory GLP
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed before the adoption of the OECD test guideline (OECD 429) for the LLNA, in 2010
Test material
- Reference substance name:
- 1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea
- EC Number:
- 266-096-3
- EC Name:
- 1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea
- Cas Number:
- 66063-05-6
- Molecular formula:
- C19H21ClN2O
- IUPAC Name:
- 1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- DHPW
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 280 - 375 g.
- Housing: The animals were kept, five to a Makrolon cage type IV.
- Diet: Altromin 3022 Diet for guinea pigs, ad libitum
- Water: drinking water from bottles, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 22-24° C
- Humidity: 30-50 %
- Photoperiod: light/dark rhythm 12 hours.
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Cremophor EL/physiological saline
- Concentration / amount:
- 1%
- Day(s)/duration:
- Day 1
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: Cremophor EL/physiological saline
- Concentration / amount:
- 25%
- Day(s)/duration:
- Topical induction was performed for 48 hours, one week after intradermal injection
- Adequacy of induction:
- other: Although the highest topical induction concentration of 25% w/v did not result in a skin reaction, this concentration is considered to be sufficient, as it is near the maximum concentration for powders to obtain a well-mixed suspension (ca. 30%).
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Cremophor EL/physiological saline
- Concentration / amount:
- 25%
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- Three animal groups (one test compound and two control groups) each consisting of 20 male animals (test compound group) and ten males (control groups)
- Details on study design:
- RANGE FINDING TESTS:
The doses in the main study were based on the results of a range-finding study using 0, 1, 2.5, and 5% w/v (intradermal induction) and 3, 6, 12.5, and 25% w/v (topical induction). Although the effects induced by intradermal injection of the test concentrations were not indicated, the intradermal induction dose was determined to be 1% w/v.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal (3 sites) and topical)
- Exposure period: 48 hours for the topical induction
- Test groups: 1 test group of 20 males.
- Control group: 2 control groups of 10 males each.
- Site:
For the intradermal induction: Starting at the back of the neck, three intradermal injections were given parallel to each flank. The intervals between the injection sites were approx. 1- 2 cm.
For the topical induction: placed between or on the injection sites
- Concentrations: 1% Pencycuron in the intradermal induction, and 25% Pencycuron for the topical induction.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1 but observed up to 48 hours after exposure.
- Exposure period: 24 hours
- Test groups: 1 test group of 20 males.
- Control group: 1 control group of 10 males each.
- Site: on the left flank of the animals
- Concentrations: 25% Pencycuron.
- Evaluation (hr after challenge): 24 and 48 - Challenge controls:
- A hypoallergenic dressing soaked in the formulation vehicle was placed on the left flank of the animals in the first control group, and fastened to the skin with occlusive tape for 24 hours.
For comparison a similar control dressing was fastened to the right flank, and this had only been soaked with the formulation vehicle. - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Not reported
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: vehicle control
- Dose level:
- 0%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: vehicle control
- Dose level:
- 0%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- 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:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- The incidence of animals with positive dermal reactions (10%) is marginally higher than the incidence of reactions to the vehicle (5%) and is not indicative of skin sensitisation.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- The incidence of animals with positive dermal reactions (10%) is marginally higher than the incidence of reactions to the vehicle (5%) and is not indicative of skin sensitisation.
- Reading:
- other: No details reported
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Pencycuron is not sensitising to the skin of guinea pigs in this Maximisation test.
- Executive summary:
Pencycuron was investigated for possible skin-allergising potential with a sensitisation test on male guinea pigs (MAGNUSSON and KLIGMAN's maximisation test). Pilot tests to establish the dose indicated that the following concentrations of the test compound should be used in the study:
intradermal induction: 1 %
topical induction: 25 %
challenge: 25 %After the challenge one animal in the test compound group reacted positively according to the evaluation criteria, while the animals in the control group did not exhibit any alterations. The degree of intensity of the response in this animal was only slight. The reaction observed in the skin of one animal is not significant, as experience has shown that individual animals can react spontaneously in this way.
The results therefore indicate that the test compound does not have a skin-sensitising effect on guinea pigs.
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