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EC number: 237-360-5 | CAS number: 13762-51-1
- 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
Effects on fertility
Description of key information
For potassium tetrahydroborate a NOAEL of 87.5 mg/kg bw and a LOAEL of 292,5 mg/kg bw can be concluded after molecular weight correction.
Link to relevant study records
- Endpoint:
- three-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No guideline specified, but conforms to the standard 3 generation 2 litters per generation multi-generation studies normally used at that time.
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Charles River Laboratory
Weight at study initiation: (P) 110 - 150 g
Diet: Ad libitum
Housing: Prior to initiation of the first breeding phase, the animals were maintained in individual cages and fed their respective diets for 14 weeks until they reached maturity. - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- 0, 670, 2000 or 6700 ppm boric acid (0, 117, 350 and 1,170 ppm boron) in the diet, equivalent to 0, 34 (5.9), 100 (17.5) and 336 (58.5) mg boric acid (boron) mg/kg bw/day.
- Dose / conc.:
- 0 ppm (nominal)
- Dose / conc.:
- 117 ppm (nominal)
- Dose / conc.:
- 350 ppm (nominal)
- Dose / conc.:
- 1 170 ppm (nominal)
- No. of animals per sex per dose:
- 8 males and 16 females per group
- Control animals:
- yes, plain diet
- Details on study design:
- At 24 hr after birth, the litters were reduced to a maximum of 8 progeny to be raised. The first filial generation (F1A) was carried through weaning and discarded. The parental generation (P1) was rebred to produce their second litter (F1B). At the time of weaning, 16 females and 8 males each from the control and test groups were selected at random and designated the second parental generation (P2) for continuation of the reproduction study. These animals were bred to produce the F2A and F2B litters as before. The F2B litter became the P3 generation and were bred to produce the F3A and F3B litters. With the exception ofthe P1, P2 and P3 control and testgroups, necropsies were performed on all rats.
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- sterility
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 336 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 350 ppm boron in the diet. No effect observed
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 58.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 17.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: No effect observed
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 350 ppm boron in the diet. No effect observed.
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 17.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: No effect observed.
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 350 ppm boron in the diet. No effect observed.
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 17.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: No effect observed.
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 336 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects in the absence of other toxic effects
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 58.5 other: mg/kg bw/day as boron equivalents
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects in the absence of other toxic effects
- Conclusions:
- In rat reproduction studies, doses of 1170 ppm borax or boric acid as boron equivalent were found to interfere with reproduction, while doses of 350 ppm boron in borax and boric acid had no adverse effect on fertility, lactation, littersize, weight or appearance.
At the highest dose of 1100 ppm rats were sterile.
There were no adverse effects on reproduction reported at exposures of 34 and 100 mg/kg bw boric acid (5.9 and 17.5 mg boron equivalents).
Based on these study data, the authors concluded that exposure of rats at levels up to 17.5 mg B/kg bw in the diet in a 3 generation reproduction study was without adverse effect. - Endpoint:
- three-generation reproductive toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- For a chronic oral uptake of potassium tetrahydroborate, the substance will decompose under acid physiological conditions. Thus the toxicity of the decomposition products, boric acid and borate salts, respectively, has to be examined to evaluate the reproduction toxicity of potassium tetrahydroborate.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No guideline specified, but conforms to the standard 3 generation 2 litters per generation multi-generation studies normally used at that time.
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Charles River Laboratory
Weight at study initiation: (P) 110 - 150 g
Diet: Ad libitum
Housing: Prior to initiation of the first breeding phase, the animals were maintained in individual cages and fed their respective diets for 14 weeks until they reached maturity. - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- 0, 670, 2000 or 6700 ppm boric acid (0, 117, 350 and 1,170 ppm boron) in the diet, equivalent to 0, 34 (5.9), 100 (17.5) and 336 (58.5) mg boric acid (boron) mg/kg bw/day.
- Dose / conc.:
- 0 ppm (nominal)
- Dose / conc.:
- 117 ppm (nominal)
- Dose / conc.:
- 350 ppm (nominal)
- Dose / conc.:
- 1 170 ppm (nominal)
- No. of animals per sex per dose:
- 8 males and 16 females per group
- Control animals:
- yes, plain diet
- Details on study design:
- At 24 hr after birth, the litters were reduced to a maximum of 8 progeny to be raised. The first filial generation (F1A) was carried through weaning and discarded. The parental generation (P1) was rebred to produce their second litter (F1B). At the time of weaning, 16 females and 8 males each from the control and test groups were selected at random and designated the second parental generation (P2) for continuation of the reproduction study. These animals were bred to produce the F2A and F2B litters as before. The F2B litter became the P3 generation and were bred to produce the F3A and F3B litters. With the exception ofthe P1, P2 and P3 control and testgroups, necropsies were performed on all rats.
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- sterility
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 336 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 350 ppm boron in the diet. No effect observed
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 58.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 17.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: No effect observed
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 350 ppm boron in the diet. No effect observed.
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 17.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: No effect observed.
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 350 ppm boron in the diet. No effect observed.
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 17.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: No effect observed.
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 336 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects in the absence of other toxic effects
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 58.5 other: mg/kg bw/day as boron equivalents
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects in the absence of other toxic effects
- Conclusions:
- In rat reproduction studies, doses of 1170 ppm borax or boric acid as boron equivalent were found to interfere with reproduction, while doses of 350 ppm boron in borax and boric acid had no adverse effect on fertility, lactation, littersize, weight or appearance.
At the highest dose of 1100 ppm rats were sterile.
There were no adverse effects on reproduction reported at exposures of 34 and 100 mg/kg bw boric acid (5.9 and 17.5 mg boron equivalents).
Based on these study data, the authors concluded that exposure of rats at levels up to 17.5 mg B/kg bw in the diet in a 3 generation reproduction study was without adverse effect.
For potassium tetrahydroborate a NOAEL of 87.5 mg/kg bw and a LOAEL of 292,5 mg/kg bw can be concluded after molecular weight correction. - Endpoint:
- three-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No guideline specified, but conforms to the standard 3 generation 2 litters per generation multi-generation studies normally used at that time.
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Charles River Laboratory
Weight at study initiation: (P) 110 - 150 g
Diet: Ad libitum
Housing: Prior to initiation of the first breeding phase, the animals were maintained in individual cages and fed their respective diets for 14 weeks until they reached maturity. - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- 0, 1030, 3080 or 10300 ppm borax (0, 117, 350 and 1,170 ppm boron) in the diet, equivalent to 0, 50 (5.9), 155 (17.5) and 518 (58.5) mg borax (boron) mg/kg bw/day.
- Dose / conc.:
- 0 ppm (nominal)
- Dose / conc.:
- 1 030 ppm (nominal)
- Dose / conc.:
- 3 080 ppm (nominal)
- Dose / conc.:
- 10 300 ppm (nominal)
- No. of animals per sex per dose:
- 8 males and 16 females per group
- Control animals:
- yes, plain diet
- Details on study design:
- At 24 hr after birth, the litters were reduced to a maximum of 8 progeny to be raised. The first filial generation (F1A) was carried through weaning and discarded. The parental generation (P1) was rebred to produce their second litter (F1B). At the time of weaning, 16 females and 8 males each from the control and test groups were selected at random and designated the second parental generation (P2) for continuation of the reproduction study. These animals were bred to produce the F2A and F2B litters as before. The F2B litter became the P3 generation and were bred to produce the F3A and F3B litters. With the exception ofthe P1, P2 and P3 control and testgroups, necropsies were performed on all rats.
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- sterility
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 518 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 155 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 350 ppm boron in the diet. No effect observed
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 58.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 17.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: No effect observed
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 155 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 350 ppm boron in the diet. No effect observed.
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 17.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: No effect observed.
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 155 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 350 ppm boron in the diet. No effect observed.
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 17.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: No effect observed.
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 518 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects in the absence of other toxic effects
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 58.5 other: mg/kg bw/day as boron equivalents
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects in the absence of other toxic effects
- Conclusions:
- In rat reproduction studies, doses of 1170 ppm borax or boric acid as boron equivalent were found to interfere with reproduction, while doses of 350 ppm boron in borax and boric acid had no adverse effect on fertility, lactation, littersize, weight or appearance.
At the highest dose of 1100 ppm rats were sterile.
There were no adverse effects on reproduction reported at exposures of 50 and 155 mg/kg bw boric acid (5.9 and 17.5 mg boron equivalents).
Based on these study data, the authors concluded that exposure of rats at levels up to 17.5 mg B/kg bw in the diet in a 3 generation reproduction study was without adverse effect. - Endpoint:
- three-generation reproductive toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- For a chronic oral uptake of potassium tetrahydroborate, the substance will decompose under acid physiological conditions. Thus the toxicity of the decomposition products, boric acid and borate salts, respectively, has to be examined to evaluate the reproduction toxicity of potassium tetrahydroborate.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No guideline specified, but conforms to the standard 3 generation 2 litters per generation multi-generation studies normally used at that time.
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Source: Charles River Laboratory
Weight at study initiation: (P) 110 - 150 g
Diet: Ad libitum
Housing: Prior to initiation of the first breeding phase, the animals were maintained in individual cages and fed their respective diets for 14 weeks until they reached maturity. - Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- 0, 1030, 3080 or 10300 ppm borax (0, 117, 350 and 1,170 ppm boron) in the diet, equivalent to 0, 50 (5.9), 155 (17.5) and 518 (58.5) mg borax (boron) mg/kg bw/day.
- Dose / conc.:
- 0 ppm (nominal)
- Dose / conc.:
- 1 030 ppm (nominal)
- Dose / conc.:
- 3 080 ppm (nominal)
- Dose / conc.:
- 10 300 ppm (nominal)
- No. of animals per sex per dose:
- 8 males and 16 females per group
- Control animals:
- yes, plain diet
- Details on study design:
- At 24 hr after birth, the litters were reduced to a maximum of 8 progeny to be raised. The first filial generation (F1A) was carried through weaning and discarded. The parental generation (P1) was rebred to produce their second litter (F1B). At the time of weaning, 16 females and 8 males each from the control and test groups were selected at random and designated the second parental generation (P2) for continuation of the reproduction study. These animals were bred to produce the F2A and F2B litters as before. The F2B litter became the P3 generation and were bred to produce the F3A and F3B litters. With the exception ofthe P1, P2 and P3 control and testgroups, necropsies were performed on all rats.
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- effects observed, treatment-related
- Description (incidence and severity):
- sterility
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 518 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 155 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 350 ppm boron in the diet. No effect observed
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 58.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- reproductive performance
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 17.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: No effect observed
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 155 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 350 ppm boron in the diet. No effect observed.
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 17.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: No effect observed.
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 155 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 350 ppm boron in the diet. No effect observed.
- Key result
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 17.5 mg/kg bw/day (nominal)
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: No effect observed.
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 518 mg/kg bw/day (nominal)
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects in the absence of other toxic effects
- Key result
- Reproductive effects observed:
- yes
- Lowest effective dose / conc.:
- 58.5 other: mg/kg bw/day as boron equivalents
- Treatment related:
- yes
- Relation to other toxic effects:
- reproductive effects in the absence of other toxic effects
- Conclusions:
- In rat reproduction studies, doses of 1170 ppm borax or boric acid as boron equivalent were found to interfere with reproduction, while doses of 350 ppm boron in borax and boric acid had no adverse effect on fertility, lactation, littersize, weight or appearance.
At the highest dose of 1100 ppm rats were sterile.
There were no adverse effects on reproduction reported at exposures of 50 and 155 mg/kg bw boric acid (5.9 and 17.5 mg boron equivalents).
Based on these study data, the authors concluded that exposure of rats at levels up to 17.5 mg B/kg bw in the diet in a 3 generation reproduction study was without adverse effect.
For potassium tetrahydroborate a NOAEL of 87.5 mg/kg bw and a LOAEL of 292,5 mg/kg bw can be concluded after molecular weight correction.
Referenceopen allclose all
Table 1: Reproduction data for rats receiving boric acid at 117 and 350 ppm as boron equivalent
Index | Control | 117 ppm | 350 ppm | Control | 117 ppm | 350 ppm |
P1 -F1A | P1 -F1B | |||||
Fertility index | 62.5 | 87.5 | 81.3 | 60.0 | 87.5 | 75.0 |
Lactation index | 56.3 | 96.2 | 70.3* | 58.8 | 85.6* | 80.0* |
Live birth index | 98.4 | 96.0 | 97.2 | 99.1 | 99.4 | 100.0 |
P2 -F2A | P2 -F2B | |||||
Fertility index | 81.3 | 93.8 | 93.8 | 80.0 | 93.8 | 93.8 |
Lactation index | 48.3 | 79.2* | 83.1* | 92.1 | 81.0 | 98.0 |
Live birth index | 97.8 | 100.0 | 99.4 | 98.6 | 99.4 | 97.9 |
P3 -F3A | P3 -F3B | |||||
Fertility index | 68.8 | 100.0 | 87.5 | 68.8 | 93.8 | 93.8 |
Lactation index | 91.5 | 82.5 | 86.5 | 89.7 | 86.7 | 87.9 |
Live birth index | 100.0 | 99.5 | 97.9 | 100.0 | 99.0 | 98.8 |
Fertility index - number of pregnancies/number of rnatings x 100.
Lactation Index = number weaned/number left to nurse x 100.
'Live blrth index - number of pups born alive/number of pups born x 100.
* Significantly higher than control.
Table 1: Reproduction data for rats receiving boric acid at 117 and 350 ppm as boron equivalent
Index | Control | 117 ppm | 350 ppm | Control | 117 ppm | 350 ppm |
P1 -F1A | P1 -F1B | |||||
Fertility index | 62.5 | 87.5 | 81.3 | 60.0 | 87.5 | 75.0 |
Lactation index | 56.3 | 96.2 | 70.3* | 58.8 | 85.6* | 80.0* |
Live birth index | 98.4 | 96.0 | 97.2 | 99.1 | 99.4 | 100.0 |
P2 -F2A | P2 -F2B | |||||
Fertility index | 81.3 | 93.8 | 93.8 | 80.0 | 93.8 | 93.8 |
Lactation index | 48.3 | 79.2* | 83.1* | 92.1 | 81.0 | 98.0 |
Live birth index | 97.8 | 100.0 | 99.4 | 98.6 | 99.4 | 97.9 |
P3 -F3A | P3 -F3B | |||||
Fertility index | 68.8 | 100.0 | 87.5 | 68.8 | 93.8 | 93.8 |
Lactation index | 91.5 | 82.5 | 86.5 | 89.7 | 86.7 | 87.9 |
Live birth index | 100.0 | 99.5 | 97.9 | 100.0 | 99.0 | 98.8 |
Fertility index - number of pregnancies/number of rnatings x 100.
Lactation Index = number weaned/number left to nurse x 100.
'Live blrth index - number of pups born alive/number of pups born x 100.
* Significantly higher than control.
Table 1: Reproduction data for rats receiving boric acid at 117 and 350 ppm as boron equivalent
Index | Control | 117 ppm | 350 ppm | Control | 117 ppm | 350 ppm |
P1 -F1A | P1 -F1B | |||||
Fertility index | 62.5 | 68.8 | 75.0 | 60.0 | 62.5 | 75.0 |
Lactation index | 56.3 | 63.6 | 82.3* | 58.8 | 60.0 | 74.2* |
Live birth index | 98.4 | 98.4 | 100.0 | 99.1 | 99.2 | 99.4 |
P2 -F2A | P2 -F2B | |||||
Fertility index | 81.3 | 81.3 | 100.0 | 80.0 | 75.0 | 93.8 |
Lactation index | 48.3 | 79.8* | 82.7* | 92.1 | 93.2 | 95.5 |
Live birth index | 97.8 | 99.4 | 96.9 | 98.6 | 92.4 | 98.8 |
P3 -F3A | P3 -F3B | |||||
Fertility index | 68.8 | 87.5 | 100.0* | 68.8 | 87.5 | 100.0 |
Lactation index | 91.5 | 81.1 | 79.1** | 89.7 | 91.8 | 95.9 |
Live birth index | 100.0 | 100.0 | 97.9 | 100.0 | 100.0 | 100.0 |
Fertility index - number of pregnancies/number of rnatings x 100.
Lactation Index = number weaned/number left to nurse x 100.
'Live blrth index - number of pups born alive/number of pups born x 100.
* Significantly higher than control.
** Significantly lower than control.
Table 1: Reproduction data for rats receiving boric acid at 117 and 350 ppm as boron equivalent
Index | Control | 117 ppm | 350 ppm | Control | 117 ppm | 350 ppm |
P1 -F1A | P1 -F1B | |||||
Fertility index | 62.5 | 68.8 | 75.0 | 60.0 | 62.5 | 75.0 |
Lactation index | 56.3 | 63.6 | 82.3* | 58.8 | 60.0 | 74.2* |
Live birth index | 98.4 | 98.4 | 100.0 | 99.1 | 99.2 | 99.4 |
P2 -F2A | P2 -F2B | |||||
Fertility index | 81.3 | 81.3 | 100.0 | 80.0 | 75.0 | 93.8 |
Lactation index | 48.3 | 79.8* | 82.7* | 92.1 | 93.2 | 95.5 |
Live birth index | 97.8 | 99.4 | 96.9 | 98.6 | 92.4 | 98.8 |
P3 -F3A | P3 -F3B | |||||
Fertility index | 68.8 | 87.5 | 100.0* | 68.8 | 87.5 | 100.0 |
Lactation index | 91.5 | 81.1 | 79.1** | 89.7 | 91.8 | 95.9 |
Live birth index | 100.0 | 100.0 | 97.9 | 100.0 | 100.0 | 100.0 |
Fertility index - number of pregnancies/number of rnatings x 100.
Lactation Index = number weaned/number left to nurse x 100.
'Live blrth index - number of pups born alive/number of pups born x 100.
* Significantly higher than control.
** Significantly lower than control.
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 87.5 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Justification for classification or non-classification
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