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Diss Factsheets
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EC number: 213-361-6 | CAS number: 939-48-0
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Experiment conducted prior to establishment of guideline; documentation is incomplete but conducted by a reputable industry laboratory.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No environmental conditions data is provided in the study report.
- Vehicle:
- other: Acetone
- Concentration:
- 3% w/v, 10% w/v and 30% w/v.
- No. of animals per dose:
- No details
- Details on study design:
- A sample of Isopropyl Benzoate was assessed for its skin sensitisation potential using the mouse Local Lymph Node Assay. The assay determines
the level of T lymphocyte proliferation in the lymph nodes drainage at the site of chemical application, by measuring the amount of radiolabelled thymidine incorporated into the dividing cells. The test substance was applied as 3%, 10% or 30% w/v preparations in Acetone. - Positive control substance(s):
- not specified
- Parameter:
- SI
- Remarks on result:
- other: see table below
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: see table below
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- IPB is a potential sensitizer in the conditions of the test.
Reference
|
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Isopropyl benzoate is positive in the LLNA, showing an EC3 value of 4.0 when 30% concentration was tested in mice. Stimulation index values were less than 3 when concentrations at or below 10% were tested. This study precedes refinement of the method and establishment of the guideline. In an assay using the Buehler protocol in guinea pigs, undiluted but not a 75% concentration of IPB resulted in sensitisation (15%) of the animals. These data are suggestive of IPB acting as a mild sensitiser in animals. Alkyl benzoate esters, at concentrations up to about 20%, have long been used safely in cosmetic product formulations without reports of dermal sensitisation.
Migrated from Short description of key information:
Isopropyl benzoate is positive in the LLNA and the Buehler protocol in guinea pigs.
Justification for selection of skin sensitisation endpoint:
experimental data
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
- Migrated from Short description of key information:
No data
Justification for classification or non-classification
As isopropyl benzoate has been demonstrated to induce sensitisation in both the LLNA assay and the Buehler assay, the substance is considered a dermal sensitiser and is classified as Category 1 under Regulation EC No. 1272/2008.
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.
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