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EC number: 271-867-2 | CAS number: 68610-51-5
- 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
Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene were tested in guinea pigs according to OECD Guidelines 406, under GLP conditions. The substance elicited a mild dermal sensitization response (Grade II) when challenged and rechallenged at 5%.
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:
- 24 November - 29 December, 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study is performed according OECD Guideline 406 under GLP conditions. No deviations reported, although the identity and quality of the tested substance is not controlled.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was conducted prior to the introduction of the LLNA method being available.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elm Hill Breeding Laboratories
- Age: 5 weeks
- Weight at study initiation: 300 - 355 g
- Housing: individually in wire mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26 C
- Humidity (%): 40 - 70
- Air changes (per hr): not mentioned
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- petrolatum
- Concentration / amount:
- 5% (intradermal) and 25% (epicutaneous)
- Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 5%
- No. of animals per dose:
- 10/sex for both vehicle control and test substance; 3/sex for positive control
- Details on study design:
- RANGE FINDING TESTS: 4 guinea pigs exposed to varying concentrations
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 6 test sites per animal
- Exposure period: 7 + 14 days
- Test groups: 5 (intradermal) and 25% Wingstay L (topical)
- Control group: Vehicle and DNCB
- Site: 6 sites
- Frequency of applications: once at day 0 and day 8
- Duration: 7 + 14 days
- Concentrations: 5 and 25% Wingstay L
B. CHALLENGE EXPOSURE
- No. of exposures:
- Day(s) of challenge: at day 22 and day 28
- Exposure period: 24 hours
- Test groups: 5% Wingstay L
- Control group: Vehicle and DNCB
- Site:
- Concentrations: 5% Wingstay L
- Evaluation (hr after challenge): 24 and 48 hours
OTHER: - Challenge controls:
- 1-chloro-2,4-dinitrobenzene (DNCB)
- Positive control substance(s):
- yes
- Positive control results:
- See table 1 and 2.
- Remarks on result:
- other: See table below
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- A study in 46 male and female guinea pigs revealed that Wingstay L did induce a mild dermal sensitization response (Grade II) upon 5% intradermal and 25% topical exposure. However, this result is not considered sufficient to classify the substance according to CLP. The study was performed according to the general guidelines for hypersensivity testing under GLP conditions.
Reference
none
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The data of one study in guinea pigs meets the requirements of the current guidelines, although the identity and quality control of the tested substances is not demonstrated. Assuming that a 100% pure testing substance was used, a mild dermal sensitization response (Grade II) was elicited. This response, however, is not considered sufficient to classify the substance (see justification for non-classification).
Justification for selection of skin sensitisation endpoint:
Only 1 study is available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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.