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EC number: 237-403-8 | CAS number: 13774-25-9
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Draize scoring system slightly modified, but with no effect on the results. - Test procedure, housing conditions, purity and stability were missing in the report. - Overall, the study is still good enough documented in order to use the study for RA.
- Justification for type of information:
- see attachment “Read-across concept – Human Health/Environment - Category approach for Inorganic sulfites/thiosulfates/dithionite" in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- , see "Rationale for reliability" above
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium sulphite
- EC Number:
- 231-821-4
- EC Name:
- Sodium sulphite
- Cas Number:
- 7757-83-7
- Molecular formula:
- NA2SO3
- IUPAC Name:
- disodium sulfite
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Natriumsulfit aktiviert wasserfrei
- Chemical description: Sodium sulfit + 0.5% cobalt sulfate
- Molecular formula: Na2SO3 + 0.5% CoSO4 * 7H2O
- Physical state: Solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: Mean body weight of male rabbits: 2.78 kg; mean body weight of female rabbits = 3.36 kg
- Diet (e.g. ad libitum): SSNIFF of the company Intermast
no furthre information on the test animals was stated.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 162 mg of test item (equivalent to 0.1 ml bulk volume)
No further information on the amount/concentration applied was stated. - Duration of treatment / exposure:
- No data
- Observation period (in vivo):
- Readings: 1 h, 24 h, 48 h, 72 h, 8 d after application
- Number of animals or in vitro replicates:
- Total: 6 rabbits (2 males/ 4 females)
- Details on study design:
- SCORING SYSTEM:
-Assessment: Modified Draize scoring system
Cornea/chemosis:
0 = not observed
1 = slight
2 = clear
3 = heavy
4 = very heavy
Conjunctival redness:
0 = normal
1 = slight intensified
2 = clear
3 = heavy
Iris:
1 = ciliar injection
2 = iritis
Area of opacity:
1 = > 0; < 1/4
2 = ≥ 1/4; < 1/2
3 = ≥ 1/2; < 3/4
4 = ≥ 3/4
Secretion:
0 = normal
1 = slightly increased
2 = clearly increased
3 = heavily increased
TOOL USED TO ASSESS SCORE: Fluorescein was used at the reading on Day 8 after application
No further information on the study design was stated.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- Animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #11
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: At 24 hours blood was observed.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: Slight conjunctival redness was again observed on Day 8.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: At 24 hours blood was observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: Slight conjunctival redness was again observed on Day 8
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritant / corrosive response data:
- The following observations wer made during the 1-hour observation:
Animal #1: Clear conjunctival redness and chemosis (Score 2); slight secretion; blood was seen
Animal #2: Clear conjunctival redness and chemosis (Score 2); clearly secretion; blood was seen
Animal #3: Clear conjunctival redness and chemosis (Score 2); slight secretion
Animal #4: Clear conjunctival redness and chemosis (Score 2); clearly secretion; blood was seen
Animal #5: Clear conjunctival redness (Score 2) and heavy chemosis; clearly secretion; blood was seen
Animal #6: Slight conjunctival redness (Score 1) and chemosis (Score 2); clearly secretion
Any other information on results incl. tables
Overall irritation/corrosion results:
Irritation parameter |
Basis |
Time point |
Score |
Max. score |
Reversibility |
Remarks |
Cornea score |
Mean animal #1 |
24, 48, and 72 hours |
0 |
4 |
|
|
Iris score |
Mean animal #1 |
24, 48, and 72 hours |
0 |
2 |
|
|
Conjunctivae score |
Mean animal #1 |
24, 48, and 72 hours |
1.67 |
3 |
fully reversible within: 8 days |
|
Chemosis score |
Mean animal #1 |
24, 48, and 72 hours |
0.33 |
4 |
fully reversible within: 48 hours |
|
Cornea score |
Mean animal #2 |
24, 48, and 72 hours |
0 |
4 |
|
At 24 hours blood was observed. |
Iris score |
Mean animal #2 |
24, 48, and 72 hours |
0 |
2 |
|
|
Conjunctivae score |
Mean animal #2 |
24, 48, and 72 hours |
0.67 |
3 |
fully reversible within: 48 hours |
|
Chemosis score |
Mean animal #2 |
24, 48, and 72 hours |
0.67 |
4 |
fully reversible within: 48 hours |
|
Cornea score |
Mean animal #3 |
24, 48, and 72 hours |
0 |
4 |
|
|
Iris score |
Mean animal #3 |
24, 48, and 72 hours |
0 |
2 |
|
|
Conjunctivae score |
Mean animal #3 |
24, 48, and 72 hours |
0.33 |
3 |
fully reversible within: 48 hours |
Slight conjunctival redness was again observed on Day 8. |
Chemosis score |
Mean animal #3 |
24, 48, and 72 hours |
0 |
4 |
|
|
Cornea score |
Mean animal #4 |
24, 48, and 72 hours |
0 |
4 |
|
At 24 hours blood was observed. |
Iris score |
Mean animal #4 |
24, 48, and 72 hours |
0 |
2 |
|
|
Conjunctivae score |
Mean animal #4 |
24, 48, and 72 hours |
1.33 |
3 |
fully reversible within: 72 hours |
Slight conjunctival redness was again observed on Day 8. |
Chemosis score |
Mean animal #4 |
24, 48, and 72 hours |
0.33 |
4 |
fully reversible within: 48 hours |
|
Cornea score |
Mean animal #5 |
24, 48, and 72 hours |
0 |
4 |
|
|
Iris score |
Mean animal #5 |
24, 48, and 72 hours |
0 |
2 |
|
|
Conjunctivae score |
Mean animal #5 |
24, 48, and 72 hours |
1.33 |
3 |
|
|
Chemosis score |
Mean animal #5 |
24, 48, and 72 hours |
1 |
4 |
|
|
Cornea score |
Mean animal #6 |
24, 48, and 72 hours |
0 |
4 |
|
|
Iris score |
Mean animal #6 |
24, 48, and 72 hours |
0 |
2 |
|
|
Conjunctivae score |
Mean animal #6 |
24, 48, and 72 hours |
0.33 |
3 |
fully reversible within: 48 hours |
|
Chemosis score |
Mean animal #6 |
24, 48, and 72 hours |
0.67 |
4 |
fully reversible within: 48 hours |
Animal | 1 | 2 | 3 | 4 | 5 | 6 |
Animal No. | 0163 | 0162 | 0185 | 0159 | 0841 | 014 |
Animal weight (kg) | 3.44 | 3.47 | 3.49 | 3.02 | 3.16 | 2.40 |
Sex | female | female | female | female | male | male |
Readings | Animal | Cornea | Iris | Conjunctivae | Signs | |||
Opacity | Area | Redness | Swelling | Discharge | ||||
24 hours | 1 | 0 | 0 | 0 | 2 | 1 | 2 | |
2 | 0 | 0 | 0 | 2 | 2 | 2 | ||
3 | 0 | 0 | 0 | 1 | 0 | 0 | ||
4 | 0 | 0 | 0 | 2 | 1 | 1 | Scar | |
5 | 0 | 0 | 0 | 1 | 2 | 1 | ||
6 | 0 | 0 | 0 | 1 | 2 | 2 | ||
48 hours | 1 | 0 | 0 | 0 | 2 | 0 | 0 | |
2 | 0 | 0 | 0 | 0 | 0 | 0 | ||
3 | 0 | 0 | 0 | 0 | 0 | 0 | ||
4 | 0 | 0 | 0 | 2 | 0 | 0 | Scar | |
5 | 0 | 0 | 0 | 2 | 1 | 1 | ||
6 | 0 | 0 | 0 | 0 | 0 | 0 | ||
72 hours | 1 | 0 | 0 | 0 | 1 | 0 | 0 | |
2 | 0 | 0 | 0 | 0 | 0 | 0 | ||
3 | 0 | 0 | 0 | 0 | 0 | 0 | ||
4 | 0 | 0 | 0 | 0 | 0 | 0 | Scar | |
5 | 0 | 0 | 0 | 1 | 0 | 0 | ||
6 | 0 | 0 | 0 | 0 | 0 | 0 | ||
8 days | 1 | 0 | 0 | 0 | 0 | 0 | 0 | |
2 | 0 | 0 | 0 | 0 | 0 | 0 | ||
3 | 0 | 0 | 0 | 1 | 0 | 0 | ||
4 | 0 | 0 | 0 | 1 | 0 | 0 | Scar | |
5 | 0 | 0 | 0 | 0 | 0 | 0 | ||
6 | 0 | 0 | 0 | 0 | 0 | 0 | ||
mean 24 - 72 h | 1 | 0.0 | 0.0 | 0.0 | 1.7 | 0.3 | 0.7 | |
2 | 0.0 | 0.0 | 0.0 | 0.7 | 0.7 | 0.7 | ||
3 | 0.0 | 0.0 | 0.0 | 0.3 | 0.0 | 0.0 | ||
4 | 0.0 | 0.0 | 0.0 | 1.3 | 0.3 | 0.3 | ||
5 | 0.0 | 0.0 | 0.0 | 1.3 | 1.0 | 0.7 | ||
6 | 0.0 | 0.0 | 0.0 | 0.3 | 0.7 | 0.7 | ||
mean | 0.0 | 0.0 | 0.0 | 0.9 | 0.5 | 0.5 |
Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris) - Vessels normal 0 - Vessels definitely injected above normal 1 - More diffuse, deeper crimson red, individual vessels not easily discernible 2
Chemosis - No swelling 0 - Any swelling above normal (includes nictitating memnbrane) 1 - Obvious swelling with partial eversion of lids 2
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Sodium sulphite is not an eye irritant.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as eye irritant.
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