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EC number: 233-162-8 | CAS number: 10049-04-4
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995-03-15 to 1995-04-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- Principles of method if other than guideline:
- not applicable
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Chlorine dioxide
- EC Number:
- 233-162-8
- EC Name:
- Chlorine dioxide
- Cas Number:
- 10049-04-4
- Molecular formula:
- ClO2
- IUPAC Name:
- Chlorine Dioxide
- Details on test material:
- Specification: 0.2% solution (stated in report as 2 ‰ solution)
Description: Yellow aqueous solution
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 Italia
- Age at study initiation: 7-9 weeks on receipt
- Weight at study initiation: on receipt: males 225-250 g, females 200-225 g
- Housing: 5 animals/sex/cage
- Diet: GLP 4RF21 top certificate pelleted diet produced by Charles River ad libitum
- Water: from the municipal water main system filtered and distributed ad libitum
- Acclimation period: 5 days, daily observation
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/- 2 °C
- Humidity: 55 +/- 10 %
- Air changes: about 20/hour filterd on HEPA 99.97 %
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Total volume of test material applied: 10, 20 and 40 mL/kg b.w.
- Doses:
- Dose levels: 20, 40 and 80 mg/kg b.w.
- No. of animals per sex per dose:
- Number of animals per group 10 animals: 5/sex/group
- Control animals:
- no
- Details on study design:
- No additional data
- Statistics:
- No data
Results and discussion
- Preliminary study:
- No data
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 93.86 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 45.52 - 193.53
- Remarks on result:
- other: The LD50 was a calculated value.
- Mortality:
- Death occurred in 2 males and 2 females treated at 80 mg/kg and in 2 males treated at 40 mg/kg within 24 – 48 hours after the test article administration. No 20 mg/kg treated rats died.
- Clinical signs:
- other: Animals treated at the lowest dose (20 mg/kg b.w.) clinically showed hypoactivity, piloerection and hunched posture during the first three days of the study and then recovered. Females treated at 40 mg/kg showed the same clinical signs up to day 5 of the
- Gross pathology:
- The autopsy of animals which died during the study showed test article-related changes in the gastrointestinal tract: congestion and erosions with mucus or test article presence in the stomach and meteorism and thinning walls with catarrhal or catarrhal-hemorrhagic content in the intestine. Congestion of the lungs, of the kidneys and of the liver (with sporadic case of congestion of the thymus, of the retropharyngeal lymph nodes and of the spleen) and decreased size of the spleen were also observed and considered as agonal or post-mortem findings.
Animals treated at 20 mg/kg (lowest dose) did not show any necroscopic changes at the autopsy performed at the end of the study. At the autopsy of the surviving animals belonging to the groups treated with the highest doses (40 and 80 mg/kg) changes in the stomach were observed. These changes consisted of thickening of the glandular mucosa and were considered test article related. - Other findings:
- No other findings
Any other information on results incl. tables
Table 7.2.1/1: Table for Acute Toxicity |
||||
Dose (mg/kg) |
Number of dead / |
Time of death (range) |
Observations |
|
0 |
N/A |
N/A |
N/A |
|
20 |
0/10 |
N/A |
N/A |
|
40 |
2/10 |
day 1 (1 animal) day 2 (1 animal) |
Two male animals |
|
80 |
4/10 |
day 2 (3 animals) |
Two female, two male animals |
|
LD50 value |
93.86 (95% C.L. = 45.52 – 193.53) |
|
||
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Under the test conditions, oral LD50 Combined Males/Females = 93.86 mg/kg b.w..(95% C.L of 45.52 – 193.53 mg/kg). Therefore, Chlorine dioxide at 0.2% is classified Category 3 (H301: Toxic if swallowed) according to the CLP regulation (1272/2008) and to the GHS, as the LD50 value is comprised between 50 and 300 mg/kg bw.
- Executive summary:
In an acute toxicity study conducted according to the OECD guideline No. 401 and in compliance with GLP, Sprague-Dawley rats were administered Chlorine Dioxine (as a 0.2 % solution in water) by gavage at doses of 20, 40 and 80 mg/kg bw. Animals were then observed for 7 days for mortality, body weight changes. Gross autopsy was performed at the end of the experiment.
Death occurred in 2 males and 2 females treated at 80 mg/kg b.w. and in 2 males treated at 40 mg/kg b.w. within 24 -48 hours after the test substance administration. No rat died in the 20 mg/kg b.w. group.
Oral LD50combined = 93.86 mg/kg bw (95% C.L. of 45.52 -193.53 mg/kg bw).
Animals treated at the lowest dose (20 mg/kg b.w.) clinically showed hypoactivity, piloerection and hunched posture during the first three days of the study and then recovered.
Females treated at 40 mg/kg bw showed the same clinical signs up to day 5 of the study. Males treated at 40 mg/kg bw and all animals treated at the highest dose (80 mg/kg bw) showed clinical signs involving the CNS, the respiratory tract, and also piloerectoin, hunched posture and salivation. All reviving animals recovered within days 4 -7 of the study.
The autopsy of animals which died during the study showed test substance-related changes in the gastrointestinal tract: congestion and erosions with mucus or test substance presence in the stomach and thinning walls with catarrhal or catarrhal-hemorrhagic content in the intestine. Congestion of the lungs, of the kidneys and of the liver and decreased size of the spleen were also observed. Animals treated at 20 mg/kg bw didn't show any necroscopic changes at the autopsy performed at the end of the study.
The surviving animals belonging to the groups treated with the highest doses (40 and 80 mg/kg bw) showed changes in the stomach (thickening of the glandular mucosa) considered test substance related. There were no treatment related changes in body weight.
This acute oral study is classified as acceptable. It does satisfy with the guidelines requirements for an acute oral study (OECD 401) in the rats.
Under the test conditions, Chlorine dioxide at 0.2% is classified Category 3 (H301: Toxic if swallowed) according to the CLP regulation (1272/2008) and to the GHS, as the LD50 value is comprised between 50 and 300 mg/kg bw. Effects observed are related to the corrosive properties of ClO2.
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