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EC number: 224-069-3 | CAS number: 4191-73-5
- 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
Key study was conducted byAnna Sonnenburg et al.(Arch Toxicol ,2015) to evaluate the skin sensitizing potential of target substance Isopropyl 4-hydroxybenzoate (4191-73-5) by in vitro experiment on humankeratinocytes.Isopropyl 4-hydroxybenzoate (4191-73-5) was assessed for its skin sensitizing potential by In-vitro method. For this purpose isloose‑fit coculture‑based sensitization assay(LCSA)wasperformed using Human keratinocytes.Human keratinocytes were used for the study. 12-well cell culture plates were used for the cocultured of the cell. Substances were tested for three different DC-rc/KC-donor pairs to account for interindividual variability.Sensitization potency of the test substances was assessed by flow cytometric analysis of the DC-rc maturation marker CD86. Determination of the concentration required to cause a half-maximal increase in CD86-expression (EC50sens) allowed a quantitative evaluation. Substances were categorized as follows: half-maximal increase in CD86-expression
<12.5 μM: extreme;
<50 μM: strong;
<100 μM: moderate;
>100 μM: weak.
The EC50 sensitization was found to be 157.84 μmol/l forIsopropyl 4-hydroxybenzoate.Therefore,Isopropyl 4-hydroxybenzoate (4191-73-5)) was considered to be sensitizing to human keratinocytes cells.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from publication.
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- To evaluate the skin sensitizing potential of isopropyl 4-hydroxybenzoate in vitro method of loose-fit coculture-based sensitization assay(LCSA).
- GLP compliance:
- not specified
- Type of study:
- other: loose-fit coculture-based sensitization assay (LCSA)
- Justification for non-LLNA method:
- Not specified
- Specific details on test material used for the study:
- - Name of test material: Isopropyl p-hydroxybenzoate
- IUPAC name: isopropyl 4-hydroxybenzoate
- Molecular formula: C10H12O3
- Molecular weight: 180.202 g/mol
- Substance type: Organic
- Physical state: No data - Details on the study design:
- Skin sensitisation (In vitro test system) - Loose-fit coculture-based sensitization assay
Keratinocytes were isolated from skin which was received as residual material from plastic surgery. Peripheral blood mononuclear cells were enriched from buffy coats by density centrifugation. Cells were cocultured in serum-free Keratinocyte growth medium 2 on 12-well cell culture plates. Increasing concentrations of test substances were tested until significant cytotoxicity or decreased solubility occurred.
Viability of cells was measured by 7-AAD staining. Each substance was tested with three different DC-rc/KC-donor pairs to account for interindividual variability
The LCSA is based on a co -culture of primary human keratinocytes and allogenic dendritic cell-related cells (DC-rc) which upregulate the expression of the maturation marker CD86 when incubated with sensitizers. - Positive control results:
- At least 1.4-fold increase in CD86-expression compared to zero controls.
- Key result
- Run / experiment:
- other: In Loose-fit coculture-based sensitization assay ,the EC50 value for test material was 157.84 μmol/l.
- Parameter:
- other: EC50
- Remarks:
- Substance concentration causing a half-maximal increase in CD86-expression
- Value:
- 157.84
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of skin sensitisation
- Other effects / acceptance of results:
- OTHER EFFECTS:
According to the study ,the EC50 value for test material was 157.84 μmol/l. which falls into the wekk category of skin sensitization .
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for positive control: yes - Interpretation of results:
- other: sensitizing
- Conclusions:
- Isopropyl 4-hydroxybenzoate (4191-73-5) was observed for its skin sensitizing potential by Invitro method of loose-fit coculture-based sensitization assay (LCSA) .Isopropyl 4-hydroxybenzoate was considered to be sensitizing by Invitro method .
- Executive summary:
Isopropyl 4-hydroxybenzoate (4191-73-5) was assessed for its skin sensitizing potential by In-vitro method. For this purpose isloose‑fit coculture‑based sensitization assay(LCSA)was performed usingHuman keratinocytes.Human keratinocytes were used for the study. 12-well cell culture plates were used for the cocultured of the cell. Substances were tested for three different DC-rc/KC-donor pairs to account for interindividual variability.Sensitization potency of the test substances was assessed by flow cytometric analysis of the DC-rc maturation marker CD86. Determination of the concentration required to cause a half-maximal increase in CD86-expression (EC50sens) allowed a quantitative evaluation. Substances were categorized as follows: half-maximal increase in CD86-expression
<12.5 μM: extreme;
<50 μM: strong;
<100 μM: moderate;
>100 μM: weak.
The EC50 sensitization was found to be 157.84 μmol/l forIsopropyl 4-hydroxybenzoate.Therefore,Isopropyl 4-hydroxybenzoate (4191-73-5)) was considered to be sensitizing to human keratinocytes cells.
Reference
For categorization of sensitizing potency, the substance concentration which led to a half-maximal increase in CD86-expression (EC50sens) was assessed. Substances
were categorized as follows: half-maximal increase in CD86-expression
<12.5 μM: extreme;
<50 μM: strong;
<100 μM: moderate;
>100 μM: weak.
Substances failing to elicit significant rise in CD86-expression up to the maximum test concentration were deemed non-sensitizers.
Paraben |
EC50sens/(μmol/l) |
Categorya |
Isopropyl |
157.84 |
Weak |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitization
In different studies, Isopropyl 4-hydroxybenzoate (4191-73-5) has been investigated for potential of skin sensitization to a greater or lesser extent. The key study are based on in vitro experiment on humankeratinocytes. The supporting studies are based on predicted data of In vivo experiments in human and guinea pig for target chemical. The predicted data using the Danish QSAR has also been compared with the experimental data of target.
Key study was conducted byAnna Sonnenburg et al.(Arch Toxicol ,2015) to evaluate the skin sensitizing potential of target substance Isopropyl 4-hydroxybenzoate (4191-73-5) by in vitro experiment on humankeratinocytes.Isopropyl 4-hydroxybenzoate (4191-73-5) was assessed for its skin sensitizing potential by In-vitro method. For this purpose isloose‑fit coculture‑based sensitization assay(LCSA)wasperformed using Human keratinocytes.Human keratinocytes were used for the study. 12-well cell culture plates were used for the cocultured of the cell. Substances were tested for three different DC-rc/KC-donor pairs to account for interindividual variability.Sensitization potency of the test substances was assessed by flow cytometric analysis of the DC-rc maturation marker CD86. Determination of the concentration required to cause a half-maximal increase in CD86-expression (EC50sens) allowed a quantitative evaluation. Substances were categorized as follows: half-maximal increase in CD86-expression
<12.5 μM: extreme;
<50 μM: strong;
<100 μM: moderate;
>100 μM: weak.
The EC50 sensitization was found to be 157.84 μmol/l forIsopropyl 4-hydroxybenzoate.Therefore,Isopropyl 4-hydroxybenzoate (4191-73-5)) was considered to be sensitizing to human keratinocytes cells.
Another prediction done using the Danish (Q) SAR Database, the skin sensitization was estimated to be positive on guinea pig and human for, Isopropyl 4-hydroxybenzoate. Using Battery algorithm model of Danish QSAR, Allergic Contact Dermatitis for, Isopropyl 4-hydroxybenzoate (4191-73-5) estimated to be sensitizing when applied to human and guinea pig skin.
Thus based on the above key and supporting studies on Isopropyl 4-hydroxybenzoate (4191-73-5),it can be concluded thatIsopropyl 4-hydroxybenzoate (4191-73-5) is a skin sensitizer. Thus comparing the above annotations with the criteria of CLP regulation, Isopropyl 4-hydroxybenzoate (4191-73-5) can be considered as ‘classified’ for skin sensitization.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Thus comparing the above annotations with the criteria of CLP regulation, Isopropyl 4-hydroxybenzoate (4191-73-5) can be considered as ‘classified’ for skin sensitization.
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