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EC number: 231-836-6 | CAS number: 7758-19-2
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Reference Type:
- publication
- Title:
- Developmental toxicity of sodium chlorite in the rabbit.
- Author:
- Harrington RM, Romano RR and Irvine L
- Year:
- 1 995
- Bibliographic source:
- Journal of the American College of Toxicology, 14(2): 108-118
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 83-3 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Sodium chlorite
- EC Number:
- 231-836-6
- EC Name:
- Sodium chlorite
- Cas Number:
- 7758-19-2
- Molecular formula:
- ClHO2.Na
- IUPAC Name:
- sodium chlorite
- Details on test material:
- Lot/Batch number: 9NF25810B
Description: White flaky powder
Purity: 80.58 %
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source:Interfauna UK Ltd., Huntington, Cambs., UKAge/weight at study initiation:Age: 4 – 5 months oldWeight: 3.05 – 4.00 kg (at mating)
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- Mating period: Timed mated at start of study, mating period not stated.
- Duration of treatment / exposure:
- Duration of treatment: Days 7-19 (post mating)Post exposure period: 9 days
Doses / concentrationsopen allclose all
- Dose / conc.:
- 200 mg/L drinking water
- Remarks:
- 12.2 mg sodium chlorite/kg-bw/day or 9 mg chlorite/kg-bw/day
- Dose / conc.:
- 600 mg/L drinking water
- Remarks:
- 36.6 mg sodium chlorite/kg-bw/day or 27 mg chlorite/kg-bw/day
- Dose / conc.:
- 1 200 mg/L drinking water
- Remarks:
- 58.7 mg sodium chlorite/kg-bw/day or 44 mg chlorite/kg-bw/day
- No. of animals per sex per dose:
- 16 or 17
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CLINICAL OBSERVATIONS: Yes
- Time schedule: Daily from day 3 of pregnancy. The appearance time, degree and continuance of clinical signs were noted.
BODY WEIGHT: Yes
- Time schedule for examinations: Weighed on day 0 of pregnancy at the supplier’s premises. Bodyweights were recorded daily from day3 to day 22 and on days 25 and 28 of pregnancy.
FOOD CONSUMPTION AND COMPOUND INTAKE: Yes
- The amount of food was recorded every 2 days from day 3 to day 27 and over 1 day from day 27 to day 28 of pregnancy.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes Water consumption was measured daily from day 3 to day 22 of pregnancy by weighing each water bottle after filling and weighing again 24 h later. During the dosing period (days 7 to 19 of pregnancy) residue drinking water formulations were discarded and replaced with fresh formulations daily. - Ovaries and uterine content:
- Gravid uterine weightNumber of corpora luteaNumber and distribution of implantation sites. The implantations were classified as early or late resorptions.
- Fetal examinations:
- GENERALNr. of live foetuses, nr. of dead foetuses, foetal weight, external abnormalities
.SKELETALThe bones were identified and examined for normality with respect to shape, size and the extent of ossification.
SOFT TISSUEFoetuses were briefly fixed in alcohol prior to being skinned and dissected. The brain, eyes, palate and major organs and blood vessels in the thorax and abdomen were examined. The sex of the foetuses, as assessed from the appearance of the internal genitalia were recorded.
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- The only treatment – related observation was a dose – related reduction in the production of faecal pellets, which was associated with reductions in food consumption.
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Description (incidence):
- There were no treatment related mortalities There were no treatment related mortalities.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Transient reductions in body weight gain were observed at 600 and 1200 ppm at the onset of dosing. The differences from the controls were statistically significant at 1200 ppm. At 200 ppm there were no difference from controls in bodyweight gain.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Statistically significant dose-related reduction in food consumption were observed at the onset at 600 and 1200 ppm. There were no treatment-related reductions in food consumption at 200 ppm.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- There was a dose-related effect of treatment on water consumption at 600 and 1200 ppm. At the onset of dosing, water consumption was reduced by over 50% at 1200 ppm and by 20 – 30% at 600 ppm. The differences were statistically significant. There was considered to be no effect of treatment on water consumption at 200 ppm.
- Ophthalmological findings:
- not examined
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- There were no treatment-related abnormalities observed macroscopically at necropsy.
- Neuropathological findings:
- not examined
- Other effects:
- no effects observed
Maternal developmental toxicity
- Other effects:
- no effects observed
- Description (incidence and severity):
- Mean numbers of corpora lutea, implantations and live foetuses were similar in all groups and there was no adverse effect of treatment on post-implantation losses.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 600 mg/L drinking water
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 36 other: mg sodium chlorite/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 27 other: mg chlorite/kg bw/day
- Based on:
- act. ingr.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/L drinking water
- Basis for effect level:
- other: maternal toxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 12 other: mg sodium chlorite/kg bw/day
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 9 other: mg chlorite/kg bw/day
- Based on:
- act. ingr.
- Basis for effect level:
- other: maternal toxicity
Maternal abnormalities
- Key result
- Abnormalities:
- no effects observed
Results (fetuses)
- Description (incidence and severity):
- Migrated Data from removed field(s)
Field "Fetal/pup body weight changes" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.FetalPupBodyWeightChanges): not specified
Field "Description (incidence and severity)" (Path: ENDPOINT_STUDY_RECORD.DevelopmentalToxicityTeratogenicity.ResultsAndDiscussion.ResultsFetuses.DescriptionIncidenceAndSeverityFetalPupBodyWeightChanges): Mean foetal weight was slightly lower at 600 and 1200 ppm than in the control group, although this could not be definitely attributed to treatment. Mean foetal weight was similar to the control group at 200 ppm. - Changes in sex ratio:
- no effects observed
- Description (incidence and severity):
- The sex ratio of the live foetuses was similar in all groups.
- External malformations:
- no effects observed
- Description (incidence and severity):
- There was no evidence of teratogenicity at any dose level.
- Skeletal malformations:
- not specified
- Description (incidence and severity):
- There was no evidence of teratogenicity at any dose level. At 600 and 1200 ppm there were slightly higher incidences of foetuses with retardation of ossification of some bones, than in the control group. This was not unexpected as there were lower mean foetal weights in these groups.
- Other effects:
- no effects observed
- Description (incidence and severity):
- There was no evidence of teratogenicity at any dose level.
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 600 mg/L drinking water
- Basis for effect level:
- other: embryotoxicity
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- 36 other: mg sodium chlorite/kg bw/day
- Basis for effect level:
- other: embryotoxicity
- Dose descriptor:
- LOAEL
- Effect level:
- 27 other: mg chlorite/kg bw/day
- Based on:
- act. ingr.
- Basis for effect level:
- other: embryotoxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/L drinking water
- Basis for effect level:
- other: embryotoxicity
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 12 other: mg sodium chlorite/kg bw/day
- Basis for effect level:
- other: embryotoxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 9 other: mg chlorite/kg bw/day
- Based on:
- act. ingr.
- Basis for effect level:
- other: embryotoxicity
Fetal abnormalities
- Key result
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Key result
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Table A6_8_1(2)-1. Table for Teratogenic effects: Maternal effects | |||||||||||||||||
Parameter | Control data | 200 ppm | 600 ppm | 1200 ppm | dose-response | ||||||||||||
historical | study | ||||||||||||||||
Number of dams examined | N/Aa | 16 | 17 | 17 | 16 | ||||||||||||
Clinical findings during application of test substance | N/A | N/Sb | N/S | N/S | N/S | ||||||||||||
Mortality of dams (%) | N/A | 1 (0.16)* | 0 | 1 (0.16)* | 0 | ||||||||||||
Abortions | N/A | N/S | N/S | N/S | N/S | ||||||||||||
Body weight gain | N/A | Days 7 – 11 of pregnancy: transient loss | |||||||||||||||
Food consumption | N/A | Days 7 – 11 of pregnancy: transient decrease | |||||||||||||||
Water consumption | N/A | Significantly lower | Significantly lower | ||||||||||||||
Pregnancies | N/A | 13 | 13 | 12 | 14 | ||||||||||||
Necropsy findings in dams dead before end of test | N/A | N/A | N/A | N/A | N/A | N/A | |||||||||||
* Sacrificed in extremis – their condition was considered to be incidental and unrelated to sodium chlorite treatment a N/A = not applicable b N/S = not specified | |||||||||||||||||
Table A6_8_1(2)-2. Table for Teratogenic effects: Litter response (caesarean section data) | |||||||||||||||||
Parameter | Control data | 200 ppm | 600 ppm | 1200 ppm | dose-response | ||||||||||||
historical | study | ||||||||||||||||
Corpora lutea (Mean no. ± S.D) | N/A | 11.9 ± 2.3 | 11.9 ± 1.9 | 12.8 ± 2.3 | 12.1 ± 2.7 | ||||||||||||
Implantations (Mean no. ± S.D) | N/A | 10.7 ± 2.2 | 10.8 ± 1.8 | 10.7 ± 2.4 | 10.1 ± 2.2 | ||||||||||||
Total number of foetuses | N/A | 111 | 125 | 108 | 124 | ||||||||||||
Mean number of live foetuses | N/A | 8.5 ± 2.9 | 9.6 ± 1.9 | 9.0 ± 2.6 | 8.9 ± 2.4 | ||||||||||||
Pre-implantation loss (%) | N/A | 10.4 | 8.4 | 16.1 | 14.9 | ||||||||||||
Post-implantation loss (%) | N/A | 21.3 | 11.1 | 15.4 | 12.6 | ||||||||||||
Foetus weight (group mean) [g] | N/A | 35 ± 4.2 | 35.8 ± 3.7 | 33.1 ± 2.6 | 33.2 ± 3.1 | ||||||||||||
Foetal sex ratio [ratio m/f] | N/A | 55:45 | 41:59 | 48:52 | 52:48 | ||||||||||||
| |||||||||||||||||
Table A6_8_1(2)-3. Table for Teratogenic effects examination of the foetuses | |||||||||||||||||
Parameter | Control data | 200 ppm | 600 ppm | 1200 ppm | dose-response | ||||||||||||
historical | Study | ||||||||||||||||
External and visceral malformations* [%] | N/A | 28.6 | 22.8 | 32.3 | 26.8 | ||||||||||||
External and visceral anomalies* [%] | N/A | 1.5 | 0.5 | 6.6 | 2.6 | ||||||||||||
Skeletal malformations* [%] | N/A | 0.0 | 0.8 | 5.4 | 0.0 | ||||||||||||
Skeletal anomalies* [%] | N/A | 7.7 | 6.3 | 14.2 | 13.9 | ||||||||||||
Applicant's summary and conclusion
- Conclusions:
- Oral administration of sodium chlorite during organogenesis in the rabbit at 600 and 1200 ppm elicited dose related reductions in maternal water with consequent reductions in maternal food consumption, production of faecal pellets and body weight gain. Despite the maternal effects there was no evidence of embryo-lethality or teratogenicity. There was an indication of embryonic growth retardation but this was only slight, was not dose-related and could not conclusively be related to treatment. There was considered to be no effect of treatment on the mothers or on embryonic development at 200 ppm.
- Executive summary:
The aim of the study was to determine the toxicity of the test material on the development of the rats.
The test procedure was: EPA OPP 83-3 (Prenatal Developmental Toxicity Study).
The test concentrations were: 0, 200, 600 and 1200 mg/L (0, 12.2, 36.6 and 58.7 mg sodium chlorite/kg/day or 0, 9, 27 and 44 mg chlorite/kg/day). Oral administration of sodium chlorite during organogenesis in the rabbit at 600 and 1200 ppm elicited dose related reductions in maternal water with consequent reductions in maternal food consumption, production of faecal pellets and body weight gain. Despite the maternal effects there was no evidence of embryo-lethality or teratogenicity. There was an indication of embryonic growth retardation but this was only slight, was not dose-related and could not conclusively be related to treatment. There was considered to be no effect of treatment on the mothers or on embryonic development at 200 ppm.
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