Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 231-821-4 | CAS number: 7757-83-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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.
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 sulfate
- 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.
