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EC number: 231-599-9 | CAS number: 7647-15-6
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 004
Materials and methods
- Principles of method if other than guideline:
- Female Wistar rats were mated and dosed with a high and a low dose of sodium bromide in their drinking water from 2nd to the 28th day postpartum.
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Sodium bromide
- EC Number:
- 231-599-9
- EC Name:
- Sodium bromide
- Cas Number:
- 7647-15-6
- Molecular formula:
- BrNa
- IUPAC Name:
- Active bromine generated from sodium bromide and sodium hypochlorite
- Details on test material:
- - Name of test material (as cited in study report): sodium bromide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8-10 weeks.
- Diet (e.g. ad libitum): standard pelleted diet, ad libitum.
- Water (e.g. ad libitum): tap water, ad libitum.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Details on exposure:
- VEHICLE
- Concentration in vehicle: 1 or 5 g Br-/l. - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- 30 female rats were mated with 30 males of proven fertility.
- Duration of treatment / exposure:
- Days 2 to 28 postpartum.
- Frequency of treatment:
- Daily.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1 and 5 g Br-/l.
Basis:
nominal in water
(A dose of 5 g Br-/l water equals to a mean daily dose of bromide of about 220 mg).
- No. of animals per sex per dose:
- 5 dams/group.
8 pups/dam. - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: the bromide levels tested were chosen in compliance with the literature data, with the aim of ensuring that the mean intake of bromide in the animals would be effective and at the same time nonlethal.
Examinations
- Maternal examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes.
BODY WEIGHT: Yes
- Time schedule for examinations: at regular intervals.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes.
- Time schedule for examinations: at regular intervals.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes.
- Time schedule for examinations: at regular intervals. - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: No.
- Fetal examinations:
- - External examinations: Yes: size and weight were examined for each pup.
- Statistics:
- All statistical evaluation of the data was performed by nonparametric Kruskal-Wallis analysis of variance followed by the Mann-Whitney test for pairwise post hoc comparison. The difference is considered significant when p < 0.05.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
Food and water consumption: There was a gradual increase in the consumption of food in the course of lactation in both the control dams and the rats of the low-Br group, and there were no significant differences between these two groups with regard to the amount of food consumed. In the case of animals of the high-Br group, there were no changes in the food consumption during the whole lactation period. Starting from the second week of the nursing period, the amount of food consumed by these rats was markedly lower than that consumed by the control rats and the rat of the low-Br group. The same was true for the consumption of drinking water.
Body weight: the enhanced intake of bromide in the course of the lactation period did not influence significantly the body weight of the lactating rats of the low-Br group. In contrast, in the rats of the high-Br group, it caused a mild but gradual decrease of the average body weight.
Effect levels (maternal animals)
- Dose descriptor:
- LOAEL
- Effect level:
- 847.13 mg/kg bw/day (nominal)
- Based on:
- other: bromide ions.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
Mortality: all of the pups in the control group survived, whereas in the low-Br and in the high-Br experimental groups, 94.8% and 56.3% of the young survived, respectively.
Body weight: there was a very marked effect of excess bromide on the body weight of the young whose mothers drank water with the addition of 5 g bromide per liter. The body weight in these suckling were progressively lower in comparison with the control young and the young of the low-Br group.
Effect levels (fetuses)
- Dose descriptor:
- LOAEL
- Effect level:
- 847.13 mg/kg bw/day (nominal)
- Based on:
- other: bromide ions.
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table 1. Body Weight of the Dams on the 2nd, 15th, and 28th Postpartum Days, and the Difference Between the Values of the Body Weights at the End (28th day) and in the Beginning (2nd day) of the Nursing Period (Body Weight Gain).
Group |
Body weight (g) on post-partum day* |
|||
2 |
15 |
28 |
Difference (28-2) |
|
Control |
278.0 ± 16.9 |
302.8 ± 19.1 |
279.8 ± 20.5 |
1.8 ± 7.9 |
Low-Br |
248.0 ± 11.1 |
278.6 ± 8.0 |
262.6 ± 7.9 |
14.6 ± 11.2 |
High-Br |
286.2 ± 17.9 |
264.0 ± 40.2 |
229.0 ± 74.9 |
-57.2 ± 67.7a,b |
* Values are means ± SD, n = 5
a,bSignificantly diferent from the control group (ap = 0.008) and from the low-Br group (bp = 0.008).
Effect level: 5 g Bromide ions per liter was the lowest dose that produced adverse effects to the rats in the experiment. According to the author, this dose equals to a daily dose of bromide of about 220 mg per rat). Assuming a median weight of 259.7 g of the animals in the high bromide dose group, the lowest observed adverse effect level was established to be 847.13 mg Br-/kg bw/day, which equals to 1086.88 mg NaBr/kg bw/day.
Applicant's summary and conclusion
- Conclusions:
- The LOAEL for maternal toxicity and teratogenicity was established to be 847.13 mg Br-/kg bw/day (equivalent to 1086.88 mg NaBr/kg bw/day).
- Executive summary:
In the present study Female Wistar rats were mated and dosed with a high and a low dose of sodium bromide (5 and 1 g Br-/l, respectively) in their drinking water from 2nd to 28th day postpartum. Maternal examinations included clinical and body weight observations, as well as food and water consumption determinations. External examinations were performed for each pup. From the present study it can be concluded that excessive bromide intake in lactating rat dams affects both their own organisms and the organisms of their suckling young. However, marked effects were found only in dams that drank water with the addition of 5 bromide per liter (equivalent to a daily dose of bromide of about 220 mg per rat). In these dams a stagnation in the extent of the consumption of diet and water in the course of the nursing period were observed. Besides, as a consequence of an excessive intake of bromide in the course of the lactation period in the dams of the high-Br group, a gradual decrease in their average body weight was observed. Very pronounced effects of high bromide levels in the organism of the mothers were also observed in the young of the high-Br group. In this group, only 56% of the young survived. Their mean body weight on day 27 of life was less than 40% of the body weight of the control young and the general condition was very poor. Thus, the LOAEC for maternal toxicity and teratogenicity was established to be 220 mg bromide/day/rat (equivalent to 847.13 mg Br-/kg bw/day and 1086.88 mg NaBr/kg bw/day).
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