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EC number: 237-224-5 | CAS number: 13701-64-9
- 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
Numerous studies have demonstrated the toxicokinetics of boric acid and borate salts in humans and experimental animals. At physiological pHs in the aqueous layer of mucosal surfaces, prior to absorption, simple inorganic borated salts are hydrolysed to undissociated boric acid, which are readily absorbed via oral and inhalation exposure. Boric acid is not expected to hydrolyse/react further due to the high energy required to break the B – O bond. Therefore, it is expected that there will be negligible parent compound, calcium metaborate, available systemically and boric acid will be the dominant and common compound in humans and experimental animals. Therefore, a read-across approach using boric acid data is considered appropriate to use, refer to Section 13.
In an in vitro bacterial reverse mutation assay (comparable to OECD test guideline 471), the source substance, boric acid, was not mutagenic in S. typhimurium TA 1538, TA 1535, TA 1537, TA 98 and TA 100 strains tested with or without metabolic activation.
In an in vitro gene mutation study in mouse lymphoma L5178Y cells (comparable to OECD test guideline 476), the source substance, boric acid, was not mutagenic with and without metabolic activation.
In an in vitro chromosome aberration assay, conducted in general compliance with OECD guidelines, the source substance, boric acid, was not genotoxic in Chinese hamster ovary cells 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:
- key study
- Justification for type of information:
- Please refer to justification attached in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Conclusions:
- Interpretation of results (migrated information):
negative
The study was performed according to Guideline 84-2 and is comparable to OECD 471. The test substance was not mutagenic in any of the strains tested with or without metabolic activation. - Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14-05-91 to 12-08-91
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- There is a failure to justify the maximum concentration of 2500 ug/plate
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA 40 CFR Part 158; FIFRA, Section 158.340
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 84-2
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1538
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver S9 at 4 % and 10 %
- Test concentrations with justification for top dose:
- 10; 50; 100; 1000; 2500 µg/plate
- Vehicle / solvent:
- Water
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Positive controls:
- yes
- Positive control substance:
- other: 2-Anthramine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In water
DURATION
- Preincubation period: None - Evaluation criteria:
- No data
- Statistics:
- No data
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Additional information on results:
- No data
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The study was performed according to Guideline 84-2 and is comparable to OECD 471. The test substance was not mutagenic in any of the strains tested with or without metabolic activation. - Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to justification attached in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Concentration related cytotoxicity (60 % reduction over controls at 5 mg/mL)
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance was not mutagenic but cytotoxicity observed at 5 mg/mL (maximum dose level). - Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: 40 CFR Part 158 US-EPA-FIFRA, Section 156.340
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- Thymidine kinase, TK locus of the L5178Y mouse lymphoma cell line
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- No data
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix or other (Aroclor 1254 induced rat (Fischer 344) liver S9 fraction used at 1 %).
- Test concentrations with justification for top dose:
- 0, 1.2, 1.7, 2.45, 3.5 and 5.0 mg/mL boric acid.
- Vehicle / solvent:
- No data
- Positive controls:
- yes
- Positive control substance:
- 3-methylcholanthrene
- Positive controls:
- yes
- Positive control substance:
- other: Hycanthone methylsulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: ROP plus 5 % heat treated horse serum
NUMBER OF CELLS EVALUATED: Approximately 600/dose - Evaluation criteria:
- Mutations at the TK locus
- Statistics:
- No data
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Concentration related cytotoxicity (60 % reduction over controls at 5 mg/mL)
- Additional information on results:
- Concentration related cytotoxicity (60 % reduction over controls at 5 mg/mL).
Increase in ouabain resistance seen (not significant). - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance was not mutagenic but cytotoxicity observed at 5 mg/mL (maximum dose level). - Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to justification attached in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Conclusions:
- Test substance is not genotoxic with and without metabolic activation.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevent results.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Carried out to an internal NTP protocol, which generally complies with OECD guidelines.
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Although this was carried out to an internal NTP protocol, it generally complies with OECD guidelines. Other literature data confirm the results. Also based on Galloway et al; 1985.
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Target gene:
- Not applicable
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix - Aroclor 1254 induced rat (Sprague-Dawley) liver S9 fraction
- Test concentrations with justification for top dose:
- With S-9: 500, 1000, 1500 and 2000 µg/mL.
Without S-9: 1000, 1600, 2000 and 2500 µg. - Vehicle / solvent:
- Water
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In water
NUMBER OF CELLS EVALUATED: Not stated - Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Conclusions:
- Test substance is non genotoxic.
Referenceopen allclose all
Gene mutation assay results:
Concentration mg/mL |
Number of mutant cells per 106cells ± SD |
Comments give information on cytotoxicity or other |
|||
Exp 1 |
Exp 2 |
Exp 1 |
Exp 2 |
||
-S9 |
-S9 |
+S9 |
+S9 |
||
0 |
54 ± 10 |
42 ± 1 |
29 ± 10 |
36 ± 7 |
|
1.2 |
46 ± 28 |
38 ± 15 |
34 ± 0 |
36 ± 7 |
|
1.7 |
39 ± 17 |
31 ± 9 |
41 ± 7 |
49 ± 4 |
|
2.45 |
27 ± 3 |
32 ± 9 |
40 ± 16 |
36 ± 6 |
Minor cytotoxicity seen |
3.5 |
31 ± 18 |
46 ± 1 |
41 ± 13 |
41 ± 6 |
Cytotoxicity seen |
5 |
50 ± 22 |
41 ± 5 |
53 ± 2 |
47 ± 3 |
Cytotoxicity seen. Increase in + S9 in first study not reproduced. |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
In an in vivo micronucleus assay (comparable to the OECD Guideline 474) the source substance, boric acid, was not mutagenic.
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to justification attached in section 13.
- Reason / purpose for cross-reference:
- read-across source
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Conclusions:
- Interpretation of results (migrated information): negative
The test substance was not genotoxic. - Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: US-EPA-FIFRA section 158.340 Guideline 84-2
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- Swiss Webster
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- Distilled water.
- Details on exposure:
- Mice given two doses (in 10 mL distilled water) by gavage.
- Duration of treatment / exposure:
- 2 days
- Frequency of treatment:
- Animals dosed once per day.
- Post exposure period:
- No data
- Remarks:
- Doses / Concentrations:
0, 225, 450, 900, 1800, 3500 mg/kg bw/day
Basis:
actual ingested - No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Tissues and cell types examined:
- No data
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not specified
- Negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- Clinical signs included rough fur and haunched position.
- Conclusions:
- Interpretation of results (migrated information): negative
The test substance was not genotoxic.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
No adverse effects on the read-across substance, boric acid, were observed in an in vitro bacterial reverse mutation assay, in vitro gene mutation study in mouse lymphoma L5178Y cells, in vitro chromosome aberration assay in Chinese hamster ovary cells and in an in vivo micronucleus assay; therefore, in accordance to Regulation (EC) No. 1272/2008 no classification for genotoxicity is required.
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.