Registration Dossier
Registration Dossier
Diss Factsheets
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: 914-100-5 | CAS number: -
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From 12.03.1991 To 19.03.1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study has been performed according to OECD Guideline 405 and according to GLP principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sulfuric acid disodium salt
- IUPAC Name:
- Sulfuric acid disodium salt
- Reference substance name:
- Sodium sulphate
- EC Number:
- 231-820-9
- EC Name:
- Sodium sulphate
- Cas Number:
- 7757-82-6
- Molecular formula:
- Na2SO4
- IUPAC Name:
- disodium sulfate
- Details on test material:
- - Name of test material (as cited in study report): Natriumsulfat (Merck AG, Darmstadt)
- Physical state: sold (white powder)
- Analytical purity: 99.4 %
- Lot/batch No.: 711 TA 290843
- Expiration date of the lot/batch: no data
- Stability under test conditions: guaranted for the study period
- Storage condition of test material: room temperature, to avoid humidity
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: HC:NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: breeder Interfauna U.K. Ltd, Wyton, Huntingdon
- Age at study initiation: no data
- Weight at study initiation: 3.3-3.5
- Housing: individually housed in stainless steel cages
- Diet: Standard diet "Ssniff K 4" (Ssniff Spezialdiäten Gmbh, Soest), approx. 100 - 120 g per animal/day; once per day in the morning.
- Water: tap water; ad libitum
- Acclimation period: at least 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): approx. 45
- Air changes (per hr): 18
- Photoperiod: 12 hrs dark / 12 hrs light
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the other eye remained untreated and served as control.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): a volume of 100 µl of the pulverized test substance - equivalent to approx. 90 mg -. - Duration of treatment / exposure:
- 24 hours.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was rinsed with saline.
- Time after start of exposure: 24 hours
SCORING SYSTEM: The signs of cornea (opacity and area affected), iris (hyperaemia, reaction to light), conjunctivae - i.e. conjunctiva of bulbus, lids, and nictitating membrane - (erythema, chemosis), and discharge were recorded as described by DRAIZE (see below)
A) Cornea
Opacity; Decrree of density (area most dense taken for reading)
Value
- no ulcération or opacity 0
- scattered or diffuse areas of opacity (other than slight dulling of normal lustre) détails of iris clearly visible 1
- easily discernible translucent area, détails of iris slightly obscured 2
- nacreous area, no détails of iris visible, size of pupil barely discernible 3
- completely opaque cornea, iris not discernible through the opacity 4
B) Iris
- normal 0
- markedly deepened rugae, congestion, swelling, moderate circumcorneal hyper-aemia, or injection,
any of these or combination of any of thereof, iris still reacting to light (sluggish reaction is positive). 1
- no reaction to light, haemorrhage, gross destruction (any or ail of thèse) 2
C) Conjunctivae: Erythema (redness)
- blood vessels normal 0
- some blood vessels definitely hyperaemic (injected) 1
- diffuse, crimson colour, individual vessels not easily discernible 2
- diffuse, beefy redness 3
D) Conjunctivae: Chemosis: lids and/or nictitating membranes
- no swelling 0
- any swelling above normal
(includes nictitating membranes) 1
- obvious swelling with partial eversion
of lids (ectropium) 2
- swelling with lids about half closed 3
- swelling with lids more than half closed 4
TOOL USED TO ASSESS SCORE: The examinations of cornea, iris and aqueous humour were failitated using hand-slit lamp. To define epithelial damage, one drop of a 1% fluorescein solution was applied to the corneal surface 24 hours after administration of the test substance.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48, 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- The results indicate that the test substance induced slight irritation to the eye.
- Other effects:
- None reported.
Any other information on results incl. tables
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test.
Score at time point/ reversibility | Iris Max. Score: 2 |
Cornea Max. Score: 4 | Conjunctivae Max. Score: 3 | Chemosis Max. Score: 4 |
1h | 0/0/0 | 0/0/0 | 2/2/1 | 1/0/0 |
24h | 0/0/0 | 0/0/0 | 2/2/1 | 0/0/0 |
48h | 0/0/0 | 0/0/0 | 1/1/1 | 0/0/0 |
72h | 0/0/0 | 0/0/0 | 0/1/0 | 0/0/0 |
7d | 0/0/0 | 0/0/0 | 0/0/0 | 0/0/0 |
Average 24h, 48h, 72h | 0 | 0 | 1 | 0 |
Reversibility *) | - | - | C. | C. |
Average time (unit) for reversion | - | - | 7 (days) | 24 (hours) |
*) Reversibility: c.= completely reversible; n.c. = not completely reversible; n. = not reversible.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test, the test substance induced a slight irritation to the eye.
- Executive summary:
In an eye irritation study (Bayer, 1991), healthy adult albino rabbits, strain HC:NZW were exposed to a volume of 100 µl (equivalent to approx. 90 mg) of the pulverised test substance for 24 hours into the conjunctival sac of one eye of each of three rabbits. The lids were then gently held together for about one second in order to limit loss of material. The other eye remained untreated and served as control. Twenty four hours after instillation of the test substance the treated eye was rinsed with saline. In this study, the results indicate that the test substance may be regarded as 'slightly irritating to the eye'.
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.
