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EC number: 948-058-4 | 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
Toxicity to reproduction
Administrative data
- Endpoint:
- three-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 966
- Report date:
- 1966
- Reference Type:
- publication
- Title:
- Toxicologic studies on borax and boric acid.
- Author:
- Weir RJ & Fisher RS
- Year:
- 1 972
- Bibliographic source:
- Toxicology and Applied Pharmacology 23: 351 - 364.
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: No guideline specified, but conforms to the standard 3 generation 2 litters per generation MGS normally used at that time.
- Deviations:
- not specified
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Limit test:
- no
Test material
- Reference substance name:
- 1303-96-4
- EC Number:
- 603-411-9
- Cas Number:
- 1303-96-4
- IUPAC Name:
- 1303-96-4
- Details on test material:
- - Name of test material: Sodium tetraborate decahydrate (borax)
- Physical state: Fine white powder without odour
- Analytical purity: > 99 %
- Stability under test conditions: Stable
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: Charles River Laboratories, USA.
- Weight at study initiation: (P) Males: 130 - 135 g; Females: 110 - 149 g
- Diet (e.g. ad libitum): Ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- This was a three generation multigeneration study with two matings (two litters) per generation. The F1a, F2a and F3a litters were sacrificed at weaning, and the F1b and F2b litters raised and used for breeding, and the F3b killed at weaning.
- Details on mating procedure:
- - M/F ratio per cage: 1 M and 2 F per cage
- Length of cohabitation: 21 days on each occassion - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- Groups of 8 males and 16 females were used for all generations. 14 weeks before mating.
From beginning of the study until sacrifice of parents P0, and from weaning till sacrifice for the parents of the F1 and F2-generations. The high dose group P animals were sterile so only controls, low and mid dose groups were taken to the F2 and F3 generations. - Frequency of treatment:
- No data
- Details on study schedule:
- Offspring were culled to 8 per litter at 24 h after delivery.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
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 (mg B)/kg bw/day respectively
Basis:
nominal in diet
- No. of animals per sex per dose:
- 8 males, 16 females per group
- Control animals:
- yes, plain diet
- Positive control:
- No data
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 for examinations: Weekly
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes, weekly
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE : No
- Oestrous cyclicity (parental animals):
- No data
- Sperm parameters (parental animals):
- No data, except in the high dose group in which histology of the testes was performed.
- Litter observations:
- Number and sex of pups, still births, livebirths, presence of gross abnormalities, weight gain, physical or behavioural abnormalities.
- Postmortem examinations (parental animals):
- Organ weights: Uterus, ovaries, testes, brain, liver, kidneys, spleen, thyroid and adrenals
Histopathology: All parental animals were necropsied and a range of tissues preserved in formalin but not examined histologically except for testes, ovaries and uterus of the high dose group only. - Postmortem examinations (offspring):
- Organ weights: Uterus, ovaries, testes, brain, liver, kidneys, spleen, thyroid and adrenals
Histopathology: 5 of each sex from all groups of the F3b litters were necropsied and a range of tissues fixed in formalin but not examined histologically. - Statistics:
- No data
- Reproductive indices:
- No data
- Offspring viability indices:
- No data
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- 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:
- not specified
- Other effects:
- no effects observed
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)
Rats exposed to the high dose of 518 mg/kg borax (corresponding to a level of 58.5 mg B/kg bw) had reduced bodyweights though food intake was not affected and they were sterile. Microscopic examination of the atrophied testes of all males in this group showed no viable sperm. There were no adverse effects on reproduction reported at exposures of 5.9 and 17.5 mg B/kg bw. The authors reported no adverse effects on fertility, lactation, litter size, progeny weight or appearance in rats exposed to either 5.9 or 17.5 mg B/kg bw. Also, no gross abnormalities were observed in the organs from these dose groups.
Parent females:
The high dose groups of the P0 generation had reduced bodyweight without any effect on food intake. Evidence of decreased ovulation in about half of the ovaries examined from the females exposed to 58.5 mg B/kg bw and only two of 16 females produced a litter (one of which was cannibalised within 24 h) when mated with control male animals. There were no adverse effects on reproduction and no gross abnormalities were observed in the organs at exposures of 5.9 and 17.5 mg B/kg bw.
The high dose group (58.5 mg B/kg bw) males and females showed clinical signs of toxicity with rough fur, scaly tails, respiratory distress and inflamed eyelids.
Effect levels (P0)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 518 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 1170 boron in the diet based on sterility in males and females.
- Dose descriptor:
- NOAEL
- Effect level:
- 155 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 350 ppm boron in the diet.
- Dose descriptor:
- LOAEL
- Effect level:
- 58.5 mg/kg bw/day
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: Based on sterility in males.
- Dose descriptor:
- NOAEL
- Effect level:
- 17.5 mg/kg bw/day
- Based on:
- element
- Sex:
- male/female
- Basis for effect level:
- other: There were no adverse effects on reproduction reported at exposures of 5.9 and 17.5 mg B/kg bw.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- mortality observed, treatment-related
- Body weight and weight changes:
- 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
Details on results (F1)
Effect levels (F1)
open allclose all
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 155 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 350 ppm 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: There were no adverse effects on reproduction reported at exposures of 5.9 and 17.5 mg B/kg bw.
Results: F2 generation
Effect levels (F2)
open allclose all
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- 155 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Equivalent to 350 ppm 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
Parameter |
|
Control |
Low dose |
Medium dose |
High dose |
|
|||||||
Generation |
m |
f |
m |
f |
m |
f |
m |
f |
|
|
|||
Mortality |
Incidence |
P |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
|
|
|
F1 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
|
|
|||
F2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|||
Food consumption |
% of control |
Not affected |
|
|
|||||||||
Body weight gain |
% of control |
|
- |
- |
- |
- |
- |
- |
¯ |
¯ |
|
|
|
Clinical Observations |
Incidence |
|
- |
- |
- |
- |
- |
- |
+ |
+ |
|
|
|
Organ weights |
% of control |
Only effect noted was increase in absolute and relative thyroid wt. in low and mid dose groups (not thought to biologically significant) |
|||||||||||
Pathology |
|||||||||||||
Histopathologic examination |
Incidence |
Evidence of testis atrophy in high dose males of P0 generation. Evidence in ovary of reduced ovulation in high dose females. |
|||||||||||
Reproductive Performance |
|
P0 to F1a |
F1b to F2b |
F2b to F3b |
|
||||||||
cont |
low |
mid |
high |
cont |
low |
mid |
cont |
low |
mid |
|
|||
Mating index: (No. pregnant/No. mated) |
% |
63 |
69 |
75 |
0 |
80 |
75 |
94 |
69 |
88 |
100 |
|
|
Fertility index: No. litters born/No. Pregnant |
% |
100 |
100 |
100 |
- |
100 |
100 |
100 |
91 |
100 |
100 |
|
|
Birth index |
|||||||||||||
Live birth index: No.pups alive/No. born |
% |
98 |
98 |
100 |
|
99 |
92 |
99 |
100 |
100 |
100 |
|
|
Litter size |
Mean |
12 |
12 |
13 |
|
12 |
15 |
12 |
12 |
12 |
12 |
|
|
Pup weight at 24h (g) |
Mean |
7.0 |
6.8 |
7.1 |
|
6.4 |
6.2 |
7.0 |
6.0 |
7.0 |
8.0 |
|
|
Sex ratio |
Male/female |
6/6 |
6/6 |
6/7 |
|
6/6 |
8/7 |
5/7 |
6/6 |
7/5 |
6/6 |
|
|
Lactation index: Pup wt. at weaning |
|
55 |
55 |
51 |
|
56 |
58 |
53 |
48 |
52 |
52 |
|
Applicant's summary and conclusion
- Conclusions:
- Rats exposed to the high dose of 518 mg/kg bw of borax (corresponding to a level of 58.5 mg B/kg bw) were sterile. Microscopic examination of the atrophied testes of all males in this group showed no viable sperm. The authors also reported evidence of decreased ovulation in the majority of ovaries examined from the females exposed to 58.5 mg B/kg bw and no litters were obtained from these high dose females when mated with control male animals. There were no adverse effects on reproduction reported at exposures of 50 and 155 mg/kg bw borax ( 5.9 and 17.5 mg B/kg bw). The authors reported no adverse effects on fertility, lactation, litter size, progeny weight or appearance in rats exposed to either 5.9 or 17.5 mg B/kg bw. Also, no gross abnormalities were observed in the organs examined from either parents or weanlings from these dose groups. 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. Data presented with boric acid data to support the data obtained with boric acid.
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