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EC number: 202-318-7 | CAS number: 94-26-8
- 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
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames test (OECD 471): negative in S. typhimurium TA92, TA1535, TA100, TA 1537, TA94 and TA98 with metabolic activation
A read-across approach was additionally conducted on source substance isobutyl 4-hydroxybenzoate:
Ames (OECD 471): not mutagenic in S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvr A with and without metabolic activation
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- refer to analogue justification provided in IUCLID section 13
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: Source: CAS 4247-02-3, Verbaan, 2016, Ames
- Conclusions:
- The result of the available in vitro gene mutation study in bacteria performed with source substance isobutyl 4-hydroxybenzoate was negative. Therefore, as explained in the analogue justification, the target substance butyl 4-hydroxybenzoate is not expected to show mutagenic properties.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- missing 5th strain (S. typhimurium TA102 or E.coli WP2), exposure only in the presensce of S9-mix; no information on positive control; only duplicate plates tested
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 Jul 1997
- Deviations:
- yes
- Remarks:
- missing 5th strain (S. typhimurium TA102 or E.coli WP2), exposure only in the presensce of S9-mix; no information on positive and negative controls; only duplicate plates tested
- Principles of method if other than guideline:
- Method was carried out according to the method of Ames, McCann & Yamasaki (1975).
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his operon
- Species / strain / cell type:
- S. typhimurium, other: TA92, TA1535, TA100, TA1537, TA94 and TA98
- Metabolic activation:
- with
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with polychlorinated biphenyls (500 mg/kg body weight of Kanechlor KC-400 in olive oil, ip)
- Test concentrations with justification for top dose:
- 6 different concentrations; maximum dose: 1 mg/plate
The maximum dose represents the highest non-cytotoxic dose used in the experiment. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 2 days
NUMBER OF REPLICATIONS: duplicates - Evaluation criteria:
- The result was considered positive if the number of colonies found was twice the number in the control (exposed to the appropriate solvent or untreated). If no reasonable dose response was detected, additional experiments using different doses or induced mutation frequency
assays were performed. - Key result
- Species / strain:
- S. typhimurium, other: TA92, TA1535, TA100, TA1537, TA94 and TA98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- not specified
- Conclusions:
- Under the conditions of the conducted test the substance was not mutagenic in any of the six strains (TA92, TA1535, TA100, TA1537, TA94 and TA98) tested with metabolic activation up to 1mg/plate.
- Executive summary:
A bacterial gene mutation assay with butyl 4 -hydroxybenzoate was performed to a protocol similar to OECD Guideline 471 (Ishidate, 1984). In this study the substance was not mutagenic in any of the six S. typhimurium strains (TA92, TA1535, TA100, TA 1537, TA94 and TA98) tested with metabolic activation up to 1 mg/plate.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Read-across justification
There is one limited study on the bacterial mutagenicity of target substance butyl 4 -hydroxybenzoate available. The assessment of bacterial mutagenicity was additionally based on a study conducted with source substance isobutyl 4 -hydroxybenzoate as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance structurally closest to the target substance is chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13).
In vitro
CAS 94 -26 -8
A bacterial gene mutation assay with the target substance butyl 4 -hydroxybenzoate was performed to a protocol similar to OECD Guideline 471 (Ishidate, 1984). In this study the substance was not mutagenic in any of the six S. typhimurium strains (TA92, TA1535, TA100, TA 1537, TA94 and TA98) tested with metabolic activation up to 1 mg/plate.
CAS 4247-02-3
Mutagenic activity of isobutyl 4-hydroxyparaben was investigated in a bacterial reverse mutation assay (Ames test; test strains used: S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvr A according to OECD 471 (Verbaan, 2016).Test concentrations up to 1,600 µg/plate were tested in the experiment. The test compound proved to be not mutagenic to the bacterial strains.
Conclusion:
Based on the available data (weight of evidence) and following the analogue approach, butyl 4-hydroxybenzoate is not expected to be mutagenic in bacteria.
Overall concusion for genetic toxicity:
In the literature further data on genotoxicity are available on butyl 4-hydroxybenzoate. Butyl 4-hydroxybenzoate was shown to cause sister-chromatid exchange (SCE), structural chromosome aberration (CA), and DNA migration in the comet assay in Chinese hamster cells in vitro at 0.75 mM (equivalent to 0.146 mg/mL) (Tayama et al., 2007). In contrast, three publications show negative results for chromosomal aberration in Chinese hamster cells (Ishidate et al., 1984; Ishidate at al., 1978; Yoshida et al., 1978). Further, in an in vivo comet assay according to OECD 489 the test substance did not induce DNA damage in any observed organ at the limit dose of 2000 mg/kg bw (Sasaki et al., 2002).
Overall, the majority of available genotoxicity tests for butyl 4-hydroxybenzoate in mammalian cells in vitro and in vivo show negative results. Thus, butyl 4-hydroxybenzoate is not considered to be mutagenic or clastogenic.
Ishidate, M. et al. (1978) Cytotoxicity test on medical drugs. Chromosome aberration tests with Chinese hamster cells in vitro.Eisei Shikensho Hokoku 96:55--61.
Ishidate, M. et al. (1984) Primary mutagenicity screening of food additives currently used in Japan. Food Chem Toxicol 22:623--636.
Sasaki, Y. F. et al. (2002) The comet assay with 8 mouse organs: results with 39 currently used food additives. Mutation Research 519 (2002):103–119
Tayama S. et al. (2007) Genotoxic effects of environmental estrogen-like compounds in CHO-K1 cells.Mutation Research 649 (2008):114–125
Yoshida, S. et al. (1978) Cytogenetic studies of antimicrobials on cultured cells. Tokyo Toritsu Eisei Kenkyusho Kenkyo Nempo (Annu. Rep. Tokyo Metrop. Res. Lab. Public Health) 29(2): 86-88 1978
Justification for classification or non-classification
Therefore, based on the read-across approach and on data available for the target substance itself, the available data on genetic toxicity do not meet the classification criteria according to Regulation (EC) 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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