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Diss Factsheets
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EC number: 701-311-0 | CAS number: -
- 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
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Endpoint summary
Administrative data
Description of key information
A number of sub-chronic and chronic studies on boric acid and disodium tetraborate decahydrate were carried out in rats, mice and dogs. In some cases these studies are research studies (Weir and Fisher, 1972; Dixon et al, 1976; Seal and Weeth, 1980; Lee et al., 1978; Treinen and Chapin, 1991; Ku et al., 1993), but most support that boron can cause adverse haematological effects and that the main target organ of boron toxicity is the testis. The NOAEL is equivalent to 17.5 mg B/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Does not meet important study design or analytical criteria.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 452 (Chronic Toxicity Studies)
- Deviations:
- yes
- Remarks:
- A non-rodent species
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Limit test:
- no
- Species:
- dog
- Strain:
- Beagle
- Sex:
- male/female
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 104 weeks
- Frequency of treatment:
- Daily
- Remarks:
- Doses / Concentrations:
0.033, 0.067 and 0.2 % dietary level
Basis:
nominal in diet - Remarks:
- Doses / Concentrations:
These concentrations provided doses of 0, 1.7, 3.8, and 10.9 mg B/kg/day, based on the actual body weight and food consumption data in the study.
Basis: - Remarks:
- Doses / Concentrations:
Others in the scientific literature have described these doses as 0, 1.5, 2.9, and 8.8 B/kg/day, but these calculations are based on standard assumptions regarding body weight and food consumption, not on the actual data from this study.
Basis: - Remarks:
- Doses / Concentrations:
Food consumption was ad libitum.
Basis: - No. of animals per sex per dose:
- 4/sex/dose
- Control animals:
- yes, concurrent no treatment
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Dose descriptor:
- LOAEL
- Effect level:
- 0.2 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: SGOT-SGPT values were reversed at the one-year interval.
- Dose descriptor:
- LOAEL
- Effect level:
- 29 - 120 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LOAEL
- Effect level:
- 5.1 - 21 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Dose descriptor:
- LOAEL
- Effect level:
- 29 - 85 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LOAEL
- Effect level:
- 5.1 - 15 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male
- Dose descriptor:
- LOAEL
- Effect level:
- 34 - 120 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LOAEL
- Effect level:
- 6 - 21 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- female
- Critical effects observed:
- not specified
- Conclusions:
- The appearance, behaviour, appetite and elimination for the dogs in all of the dietary test levels were generally comparable with those of the controls and were within normal limits. All maintained or gained weight during the study. The haematological and biochemical values in the test dogs were in general comparable with the control and within normal limits. The SGOT-SGPT values were reversed in the male dogs of all three test levels at the one-year interval and in one male and one female in the 0.2 % group sacrificed at two years. Necropsy findings, terminal body weights, organ/body weights and organ/body weight ratios were observed to be generally within normal limits. There were no histological alterations.
Reference
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
A number of studies on boric acid or disodium tetraborate decahydrate in diet or via drinking water for periods of 30 days to two years in rats, mice and dogs are available, however, the majority of these studies do not comply with current test guidelines, and they lack essential information regarding e.g. histological descriptions and statistical evaluations of the results. Most studies support that boron can cause adverse haematological effects and that the main target organ of boron toxicity is the testis. Other effects observed at high doses include rapid respiration, hunched position, bloody nasal discharge; urine stains on the abdomen, inflamed bleeding eyes, desquamation and swollen paws and tail, reduced food consumption and body weight gain. Treatment with boric acid and disodium tetraborate decahydrate disrupted spermiation, induced degeneration of testicular tubules and caused testicular atrophy. For effects on the blood system extramedullary haematopoiesis, reduced red cell volume and haemoglobin values and deposition of haemosiderin in spleen, liver and proximal tubules of the kidney were described. Several cases of anaemia have been observed in human poisoning cases. However, although doses in these poisoning cases are difficult to define, the effects occurred generally at relatively high concentrations.
Boric acid, the main species present under physiological conditions, acts as a Lewis acid and as such owns the ability to complex with hydroxyl, amino and thiol groups from diverse biomolecules, like e.g. carbohydrates and proteins (BfR, 2006). Such a mechanism could be involved in effects of boron on different enzyme activities (Huel et al., 2004).
A NOAEL for effects on testes and the blood system of 17.5 mg B/kg bw/day can be derived (with a LOAEL of 58.5 mg B/kg bwday) from two 2-year studies in rats on boric acid and disodium tetraborate decahydrate (Weir, 1966a,b).
Repeated dose toxicity: via oral route - systemic effects (target organ)urogenital: testes
Justification for classification or non-classification
Read across repeat dose toxicity studies from boric acid indicate that the testes are adversely effected following repeated exposure to high doses of boric acid. These data, in combination with intended use conditions, is used to evaluate the potential of the substance to cause target organ toxicity. The registered substance is expected to have predictable adsorption, distribution, metabolism and excretion based on boric acid, meeting the criteria for inclusion.
Boric acid is classified under the 1stATP to CLP as Repr. 1B; H360FD.
However, text of the 30th ATP as published in the EU Official Journal, 15 September 2008 stated that“The classification and labelling of the substances listed in this Directive should be reviewed if new scientific knowledge becomes available. In this respect, considering recent preliminary, partial and not peer-reviewed information submitted by industry, special attention should be paid to further results of epidemiological studies on the Borates concerned by this Directive including the ongoing study conducted in…”
While boron has been shown to adversely affect male reproduction in laboratory animals, there was no clear evidence of male reproductive effects attributable to boron in studies of highly exposed workers (Whorton et al. 1994; Sayli 1998, 2001; Robbins et al. 2010; Scialli et al. 2010).Not only are these the most exposed workers, but the Chinese worker study is themost sensitive study that has been carried out as semen analysis was performed, a very sensitive detection system for testicular damage.There is no evidence of developmental effects in humans attributable to boron in studies of populations with high exposures to boron (Tuccar et al 1998; Col et al. 2000; Chang et al. 2006).
Several studies in laboratory animals and in vitro studies have recently been completed that demonstrate the protective effect of zinc against boric acid related developmental and fertility toxicity of boric acid. Humans have intrinsically higher levels of zinc than laboratory animals that explain in part the absence of boric acid related reproductive toxicity effects in humans. These studies provide important mechanistic data on the effects of zinc on boric acid related reproductive toxicity that raises doubt about the relevance of the effects for humans. These data provide further justification that classification of Repr. Category 2 H361d is more appropriate for boric acid than Repr. Category 1B H360FD.
Therefore, based on a total weight of evidence, Category 2 H361d: suspected human reproductive toxicant., suspected of damaging the unborn child is considered the appropriate classification. Extensive evaluations of sperm perameters in highly exposed workers have demonstrated no effects on male fertility. While no developmental effects have been seen in highly exposed populations, epidemiological studies of developmental effects are not as robust as the fertility studies, warranting the Category 2 H361d. Regarding systemic target organ toxicity after repeated exposures (STOT-RE), boric acid does not meet criteria for classification and labelling according to EU CLP Regulation (EC) No. 1272/2008) because no other than testis target organs were identified during the study (Weir, 1966).
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.
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