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Diss Factsheets
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EC number: 208-580-9 | CAS number: 533-96-0
- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study conducted by GLP laboratory according to OECD guideline method
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 438
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Trisodium hydrogendicarbonate
- EC Number:
- 208-580-9
- EC Name:
- Trisodium hydrogendicarbonate
- Cas Number:
- 533-96-0
- Molecular formula:
- CH2O3.3/2Na
- IUPAC Name:
- trisodium hydrogendicarbonate
Constituent 1
Test animals / tissue source
- Species:
- other: chicken
- Strain:
- other: ROSS, spring chicken
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 30 mg
- Duration of treatment / exposure:
- 10 seconds on 3 animals and 30 seconds on one
- Observation period (in vivo):
- 4h
- Number of animals or in vitro replicates:
- 4
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Remarks:
- 2 Irritation Index = maximum mean corneal swelling + maximum mean opacity (x 20) + mean fluorescein score (x 20).
- Basis:
- mean
- Time point:
- other: 240 min
- Score:
- 50
- Reversibility:
- not specified
Any other information on results incl. tables
Test material |
Maximum mean score for: |
Irritation categories1 |
Irritation Index2 |
Classification (EC-GHS3) |
||
Swelling % |
Opacity |
Fluorescein retention |
||||
Sodiumsesquicarbonate |
4 |
1.0 |
1.3 |
I;II;II |
50 |
NC/NI |
NaOH (positive control) |
42 |
4.04 |
3.0 |
IV;IV;IV |
182 |
Category 1 |
Saline (negative control)5 |
0 |
0.0 |
0.0 |
n.a.6 |
n.a. |
n.a. |
1 I = no effect; II = slight effect; III = moderate effect; IV = severe effect.
2 Irritation Index = maximum mean corneal swelling + maximum mean opacity (x 20) + mean fluorescein score (x 20).
3 NC/NI = non- classified/non-irritant; Category 2 = Irritating to eyes; Category 1 = irreversible effects on the eye/serious damage to the eye. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.
4 Immediate iris contraction
5 Individual values based on one eye.
6 n.a. = not applicable.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- non irritating
- Executive summary:
1. Sodiumsesquicarbonate was evaluated neat in the Isolated ChickenEye (ICE) test. Chicken eyes were obtained from slaughter animals used for human consumption. The isolated chicken eyes were exposed to a single application of the test sample for 10 seconds using an application amount of 30 mg. Because the test substance, a powder, could adhere to the cornea, one additional test eye was treated for 30 seconds in order to mimic possible prolonged exposure (up to one hour) which may occur in thein vivorabbit eye irritation test with solids. Three main parameters were measured to disclose possible adverse eye effects: corneal thickness (expressed as corneal swelling), corneal opacity and fluorescein retention of damaged epithelial cells.
2. no corneal effects.
3. caused severe swelling, very severe opacity and severe fluorescein retention. The calculated Irritation Index was 182.
4. Sodiumsesquicarbonate caused very slight swelling, slight opacity and slight or slight to moderate fluorescein retention. The calculated Irritation Index was 50. Prolonged exposure slightly increased the corneal effectsbut they were still markedly below the threshold of severe irritancy.
5. Sodiumsesquicarbonate is proposed to be non-classified/non-irritant.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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