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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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 peer-reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- The comet assay with 8 mouse organs: results with 39 currently used food additives
- Author:
- Sasaki, Yu. F.; Kawaguchi, Satomi; Kamaya, Asako; Ohshita, Miyuki; Kabasawa, Kazumi; Iwama, Kayoko; Taniguchi, Kazuyuki; Tsuda, Shuji
- Year:
- 2 002
- Bibliographic source:
- Mutation Research; vol. 519; nb. 1-2; (2002); p. 103 - 120
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Acute oral toxicity study of isopropyl 4-hydroxybenzoate in mice to set the appropriate dose of each chemical for the comet assay
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Isopropyl 4-hydroxybenzoate
- EC Number:
- 224-069-3
- EC Name:
- Isopropyl 4-hydroxybenzoate
- Cas Number:
- 4191-73-5
- Molecular formula:
- C10H12O3
- IUPAC Name:
- propan-2-yl 4-hydroxybenzoate
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): isopropyl 4-hydroxybenzoate
- Molecular formula : C10H12O3
- Molecular weight : 180.202 g/mole
- Smiles notation : c1(C(OC(C)C)=O)ccc(O)cc1
- InChl : 1S/C10H12O3/c1-7(2)13-10(12)8-3-5-9(11)6-4-8/h3-7,11H,1-2H3
- Substance type:Organic
- Physical state:Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Isopropyl Paraben (isopropyl 4-hydroxybenzoate)
- Molecular formula (if other than submission substance): C10H12O3
- Molecular weight (if other than submission substance): 180.202 g/mole
- Substance type: Organic
- Physical state: Solid
Purity >99.0%
Test animals
- Species:
- mouse
- Strain:
- other: DDY
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Source: Japan SLC Co., Shizuoka, Japan
Age at study initiation: 8 weeks
Weight at study initiation: no data available
Fasting period before study: no data available
Housing: no data available
Diet (e.g. ad libitum): commercial pellets MF (Oriental Yeast Industries Co., Tokyo, Japan), ad libitum
Water (e.g. ad libitum): Tap Water, ad libitum
Acclimation period: 1 week of acclimatization
ENVIRONMENTAL CONDITIONS
Temperature (°C): The animal room was at 20–24°C
Humidity (%): No data
Air changes (per hr): No data
Photoperiod (hrs dark / hrs light): 12 h light–dark cycle.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- Details on exposure
VEHICLE
- Concentration in vehicle: 2000 mg/kg bw
- Amount of vehicle (if gavage): No data available
- Justification for choice of vehicle:olive oil
- Lot/batch no. (if required):No data available
- Purity:No data available
MAXIMUM DOSE VOLUME APPLIED: No data available
DOSAGE PREPARATION (if unusual): Dose were prepared in olive oil
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: In order to set the appropriate dose of each chemical for the comet assay, 0.5 × LD50 or the limit dose of 2000 mg/kg were given to mice. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 4-5 male mice
- Control animals:
- not specified
- Details on study design:
- - Other examinations performed: Mortality were observed.
- Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality observed
- Mortality:
- No mortality was observed in treated male mice at 2000 mg/kg bw
- Clinical signs:
- other: not specified
- Gross pathology:
- not specified
- Other findings:
- not specified
Any other information on results incl. tables
Test chemical |
Vehicle |
Source* |
LD50** mg/kg |
p-Hydroxybenzoic acid iso-propyl ester |
Olive oil |
T |
>2000 |
*T = Tokyo Kasei Kogyo Industry Ltd., Tokyo, Japan;
** In order to set appropriate doses for the assay, we determined approximate LD50 by simple acute toxicity experiments on four–five animals. When no death was observed at 2000 mg/kg, the LD50 was defined as >2000 mg/kg.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- LD50 was considered to be > 2000 mg/kg bw when DDY male mice were treated with isopropyl 4-hydroxybenzoate orally.
- Executive summary:
In a acute oral toxicity study, DDY male mice were treated with isopropyl 4-hydroxybenzoate in the limit dose of 2000 mg/kg bw orally in Olive Oil. No mortality was observed in treated male mice at 2000 mg/kg bw. Therefore, LD50 was considered to be > 2000 mg/kg bw when DDY male mice were treated with isopropyl 4-hydroxybenzoate orally.
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