Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 231-548-0 | CAS number: 7631-90-5
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:
- The basis for the read-across concept for this project is the equilibrium between sulfites, hydrogensulfites, and metabisulfites in aqueous solutions depending on pHvalue which is clearly described in published literature and summarised in the following equations:[1],[2]
SO2+ H2O <->`H2SO3´ H2SO3<->H++ HSO3-<->2H++SO32- 2HSO3-<->H2O +S2O52 -
As the nature of the cation should make no significant difference in this case concerning toxicity and solubility (all compounds are very soluble in water), only the chemical and biological properties of the anion are considered relevant. Based on the described equilibrium correlations, we propose unrestricted read-across between the groups of sulfites, hydrogensulfites and metabisulfites.
Additionally, it is known that sodium dithionite disproportionates in water to form sodium hydrogen sulfite and sodium thiosulfate (equation II) so that this substance can also be added to the read-across concept.[2],[1]It is expected for this case that the substance is not stable enough under physiological conditions to fulfil the requirements of study guidelines and so the products of decomposition have to be considered.
2 S2O42-+ H2O→2HSO3-+ S2O32 -
Not completely included in this read-across concept is the substance class of thiosulfates. Although thiosulfates may also disproportionate in aqueous solution to form polythionic acids and SO2(HSO3-), the required conditions are somewhat different (more acidic) and are therefore not strictly comparable with physiological conditions, except for the case of oral application where read-across should be considered unrestricted due to the strongly acidic conditions in the stomach:
HS2O3-+ H2S2O3→HS3O3- + SO2 + H2O
Nevertheless, read-across for all other routes (dermal, inhalation) should also be considered.
The proposed read-across concept only applies to toxicological and ecotoxicological/environmental fate endpoints.
[1]Hollemann Wiberg, Lehrbuch der Anorganischen Chemie, 101.Auflage
[2]Handbook of Chemistry and Physics, Ed. Lide, DR, 88thedition, CRC Press
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.
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.
