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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 233-135-0 | CAS number: 10043-01-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Reliable with restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- Cited as Directive 84/449/EEC, B.5, Determination of irritant/corrosive effects were examined using rabbits, according to OECD 405.
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Sodium sulphate
- EC Number:
- 231-820-9
- EC Name:
- Sodium sulphate
- Cas Number:
- 7757-82-6
- IUPAC Name:
- disodium sulfate
- Details on test material:
- - Name of test material-sodium sulphate
Name of test material: Sodium sulfate
- CAS Number: : 7757-82-6
- EC number: 231-820-9
- Molecular formula (if other than submission substance): Na2SO4
- Molecular weight (if other than submission substance): 142.04 g/mol
- Smiles notation (if other than submission substance): Na+].[Na+].[O-]S([O-])(=O)=O
- InChI=StdInChI=1S/2Na.H2O4S/c;;1-5(2,3)4/h;;(H2,1,2,3,4)/q2*+1;/p-2
- Structural formula attached as image file (if other than submission substance): see Fig.1
- Substance type:inorganic
- Physical state:solid
- Appearance: white crystalline solid hygroscopic
- Density – 2.664 g/cm3
- Melting point- 884 °C
- - Boiling point:1429 °C
- Solubility in water – 47.6 g/L (0 °C), 427 g/L (100 °C)
- Solubility: insoluble in ethanol
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS: Rabbits
- Strain: HC:NZW
- Sex: not described
- Source: Interfauna, Ltd, UK
- Age: adults
- Weight at study initiation: not described
- Number of animals: 3
- Controls: other eye
Test system
- Vehicle:
- not specified
- Controls:
- yes
- Amount / concentration applied:
- Concentration: 90 mg
Amount applied: 100 other: µl - Duration of treatment / exposure:
- 24 hour(s)
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- ADMINISTRATION/EXPOSURE
- Preparation of test substance: Pulverized powder
- Amount of substance instilled: 90 mg
- Vehicle: not described
- Postexposure period: 21 days
- exposure : 24 hours
EXAMINATIONS
- Ophtalmoscopic examination: yes
- Scoring system: DRAIZE system
- Observation period: 21 days
- Tool used to assess score: optical instrument (hand slit
lamp)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: irrit. index 0.0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: irrit. index 0.0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 day
- Remarks on result:
- other: irrit. index 1.0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Chemosis
- Basis:
- mean
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- overall irritation score
- Score:
- 1.3
- Max. score:
- 1.3
- Reversibility:
- fully reversible within: 7 day
- Remarks on result:
- other: slightly irritating
Any other information on results incl. tables
RS-Freetext:
AVERAGE SCORE
- Cornea: 0 no effect (7 days), irrit. index 0.0
- Iris: 0 no effect (7 days) irrit. index 0.0
- Conjuntivae (Redness): 1 (48 hours) irrit. index 1.0
- Conjuntivae (Chemosis): 0 (7 days)
- Overall irritation score: 1.3 (slightly irritating)
DESCRIPTION OF LESIONS: no
REVERSIBILITY: within 7 days
OTHER EFFECTS: -
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Classification: irritating
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.
