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EC number: 435-580-8 | CAS number: 56553-60-7
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- three-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated 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:
- other: Acceptable, well documented publication with the decomposition product boric acid which meets basic scientific principles
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Toxicologic studies on borax and boric acid
- Author:
- Weir, R.J. and Fisher, R.S.
- Year:
- 1 972
- Bibliographic source:
- Toxicology and Applied Pharmacology 23: 351 - 364
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 966
- Report date:
- 1966
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: No guideline specified, but equivalent to the standard 3 generation study/multi-generation studies normally used at that time.
- Principles of method if other than guideline:
- No guideline specified, but equivalent to the standard 3 generation study/multi-generation studies normally used at that time.
- GLP compliance:
- no
- Remarks:
- prior to GLP
- Limit test:
- no
Test material
- Reference substance name:
- Boric acid
- EC Number:
- 233-139-2
- EC Name:
- Boric acid
- Cas Number:
- 10043-35-3
- Molecular formula:
- BH3O3
- IUPAC Name:
- Boric acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Boric acid
- Analytical purity: > 99 %
- Supplier: U.S. Borax Research Corp., Anaheim, California
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Cesarean-derived from Charles River
- Weight at study initiation: 110 - 150 g
- Housing: Individidually housed
- Diet (e.g. ad libitum): Purina Laboratory Chow; ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on mating procedure:
- - M/F ratio per cage: 1:2
- Length of cohabitation: 21
- Breeding schedule:
24 h after birth, the F1 litters were reduced to a maximum of eight pups and discarded when they reached 21 days of age.
The parents in the control and two lower test groups were mated again. At the time of resulting weaning animals (F1B) 16 females and 8 males from the control and two test groups were chosen randomly and designated as the second parental generation (P2) for continuation of the reproduction study. These animals were bread to produce the F2A and F2B litters as before with the F2B litter becoming the P3 generation which was bread to produce the F3A and F3B litters.
Additional breeding of the high dose P1 with control males was performed to investigate whether the female reproductive system was affected. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- From premating for 14 days until scheduled necropsy of F3 generation
- Frequency of treatment:
- Daliy, ad libitum
- Details on study schedule:
- - Schedule:
F1a, F2a and F3a litters were sacrificed at weaning, while F1b and F2b litters raised and used for breeding.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
34, 100, 336 mg/kg bw/d
Basis:
nominal in diet
Boric acid
- Remarks:
- Doses / Concentrations:
670, 2000, 6700 ppm
Basis:
nominal in diet
Boric acid
- Remarks:
- Doses / Concentrations:
5.9, 17.5, 58.8 mg/kg bw/d
Basis:
nominal in diet
Element Boron
- No. of animals per sex per dose:
- P1: 8 males and 16 females
P2: 8 males and 16 females
P3: 8 males and 16 females - Control animals:
- yes, plain diet
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: weekly
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: weekly
BODY WEIGHT: Yes
- Time schedule: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): weekly - Sperm parameters (parental animals):
- Parameters examined in all male parental generations: analysis of sperm viability
- Litter observations:
- STANDARDISATION OF LITTERS
- Yes, maximum of 8 pups/litter; excess pups were killed and discarded.
PARAMETERS EXAMINED
The following parameters were examined in all offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities
GROSS EXAMINATION OF DEAD PUPS:
yes, for external and internal abnormalities - Reproductive indices:
- Fertility index = number of pregnancies/number of matings x 100
Lactation index = number weaned/numbe left to nurse x 100 - Offspring viability indices:
- Live birth index= number of pups born alive/number of pups born x 100
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Reproductive performance:
- effects observed, treatment-related
Details on results (P0)
The high dose group (58.5 mgB/kg bw) males and females showed clinical signs of toxicity with rough fur, scaly tails, respiratory distress and inflamed eyelids.
REPRODUCTIVE FUNCTION:
When females of that group were mated with untreated males they had no offspring, indicating that the female reproduction was affected. A decreased ovulation in the majority of ovaries examined in that group was mentioned not to be sufficient to explain the observed infertility.
The high dose group P animals showed lack of viable sperm.
REPRODUCTIVE PERFORMANCE (PARENTAL ANIMALS)
There was no adverse effect on the reproduction in low and mid dose animals.
GROSS PATHOLOGY (PARENTAL ANIMALS)
No abnormalities were observed in the examined organs, except atrophied tested in the high dose males.
HISTOPATHOLOGY (PARENTAL ANIMALS)
Atrophied tested in the high dose males were seen.
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- Boric acid in diet
- Sex:
- male/female
- Basis for effect level:
- other: Arophied testes in all P1 males
- Dose descriptor:
- NOAEL
- Effect level:
- 17.5 mg/kg bw/day (nominal)
- Based on:
- element
- Remarks:
- Boron in diet
- Sex:
- male/female
- Basis for effect level:
- other: atrophied testes in all P1 males
- Dose descriptor:
- LOAEL
- Effect level:
- 336 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- Boric acid in diet
- Sex:
- male/female
- Basis for effect level:
- other: histopathology;
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Remarks:
- Boric acid in diet
- Sex:
- male/female
- Basis for effect level:
- other: Atrophied testes in all P1 males
- Remarks on result:
- other: Generation: F1, F2 (migrated information)
- Dose descriptor:
- NOAEL
- Effect level:
- 17.5 mg/kg bw/day (nominal)
- Based on:
- element
- Remarks:
- Boron in diet
- Sex:
- male/female
- Basis for effect level:
- other: Atrophied testes in all P1 males
- Remarks on result:
- other: Generation: F1, F2 (migrated information)
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- not examined
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not specified
Details on results (F1)
No change in litter size and livebirth index was noted in F1, F2 and F3 litters in low and high dose groups compared with control values.
BODY WEIGHT (OFFSPRING)
No change in body of pups in low and high dose groups weights was noted in F1, F2 and F3 litters in compared with control values.
GROSS PATHOLOGY (OFFSPRING)
No abnormalities were observed in the examined organs.
Effect levels (F1)
open allclose all
- 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 of Boron in the diet.
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 17.5 mg/kg bw/day
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: None
Results: F2 generation
Effect levels (F2)
open allclose all
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 350 ppm of Boron in the diet.
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 17.5 mg/kg bw/day
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects in mid and low dose groups in any generation.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Reproduction data:
Control | Dietary level of Boric acid | Control | Dietary level of Boric acid | |||
Index | 34 mg/kg bw/d | 100 mg/kg bw/d | 34 mg/kg bw/d | 100 mg/kg bw/d | ||
P1 - F1A | P1 - F1B | |||||
Fertility index | 62.5 | 87.5 | 81.3 | 60 | 87.5 | 75 |
lactation index | 56.3* | 96.2 | 70.3* | 58.8 | 85.6* | 80.0* |
Live birth index | 98.4 | 96 | 97.2 | 99.1 | 99.4 | 100 |
P2 - F2A | P2 - F2B | |||||
Fertility index | 81.3 | 93.8 | 80 | 93.8 | 93.8 | |
lactation index | 48.3 | 79.2* | 92.1 | 81 | 98 | |
Live birth index | 97.8 | 100 | 98.6 | 99.4 | 97.9 | |
P3 - F3A | P3 - F3B | |||||
Fertility index | 68.8 | 100 | 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 | 99.5 | 97.9 | 100 | 99 | 98.8 |
* significantly higher than control
Applicant's summary and conclusion
- Conclusions:
- Based on the sterility in the highest dose group, the NOAEL for reproduction was found to be 100 mg/kg bw/d Boric acid in diet corresponding to 17.5 mg/kg bw Boron.
- Executive summary:
In a three generation study in rats groups of 8 males and 16 females were treated with boric acid equivalent to 0, 5.9, 17.5 and 58.8 mg boron/kg bw/day. The high dose P1-generation failed to produce litter. Also when females of that group were mated with untreated males they had no offspring, indicating that the female reproduction was affected. A decreased ovulation in the majority of ovaries examined in that group was mentioned not to be sufficient to explain the observed infertility since only ovaries of high dosed females were examined. However, gross necropsy revealed atrophied testes in all P1 males at 58.8 mg boron/kg bw/day. Based on the sterility in the highest dose group, the NOAEL for reproduction was found to be 100 mg/kg bw/d Boric acid in diet corresponding to 17.5 mg/kg bw Boron.
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