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Diss Factsheets
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EC number: 938-580-0 | 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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: well-documented, scientifically acceptable study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
- Principles of method if other than guideline:
- according to Fed. Reg. 38, No. 187, & 1500.42, 1973 (Draize test) and Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, FDA, Austin, Texas, 1959
- GLP compliance:
- no
Test material
- Reference substance name:
- Sodium hydroxide
- EC Number:
- 215-185-5
- EC Name:
- Sodium hydroxide
- Cas Number:
- 1310-73-2
- Molecular formula:
- HNaO
- IUPAC Name:
- sodium hydroxide
- Details on test material:
- Name of test material (as cited in study report): Natronlauge
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: M. Gaukler, 6050 Offenbach
- Weight at study initiation: ca. 2.9 kg
- Diet (e.g. ad libitum): Ssniff K, Standard diet for rabbits and guinea pigs of the company INTERMAST GMBH, Soest.
- Water (e.g. ad libitum): Ad libitum.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 100 ul
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 8 days
- Number of animals or in vitro replicates:
- 3 (sodium hydroxide 0.95%) + 3 (sodium hydroxide 4.9%)
- Details on study design:
- Single instillation into the conjunctival sac of the right eyelid; the test substance was not washed out.
SCORING SYSTEM:
Draize scoring system for eye irritation:
Cornea
A. Opacity: degree of density (readings should be taken from most dense area): the area of corneal opacity should be noted
- No ulceration or opacity: 0
- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible: 1
- Easily discernible translucent area, details of iris slightly obscured: 2
- Nacrous area, no details of iris visible, size of pupil barely discernible: 3
- Opaque cornea, iris not discernible through the opacity: 4
B. Area of cornea involved
- One quarter (or less) but not zero: 1
- Greater than one quarter but less than one-half: 2
- Greater than one-half but less than three quarters: 3
- Greater than three quarters up to whole area: 4
Score equals AxBx5 - Total maximum = 80
Iris
A. Values
- Normal: 0
- Folds above normal, congestion, swelling, circumcorneal injection (any one or all of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive): 1
- No reaction to light, hemorrhage; gross destruction (any one or all of these): 2
Score equals Ax 5 - Total possible maximum = 10
Conjunctivae
A. Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
- Normal: 0
- Some blood vessels hyperemic (injected): 1
- Diffuse, crimson color, individual vessels not easily discernible: 2
- Diffuse beefy red: 3
B. Chemosis-Swelling (refers to lids and/or nictating membranes)
- Normal: 0
- Some swelling above normal: 1
- Obvious swelling, with partial eversion of lids: 2
- Swelling, with lids about half closed: 3
- Swelling, with lids about half closed to completely closed: 4
C. Discharge
- Normal: 0
- Any amount different from normal (does not include small amount observed in inner canthus of normal rabbits): 1
- Discharge with moistening of the lids and hairs just adjacent to the lids: 2
- Discharge with moistening of the lids and considerable area around the eye: 3
Score equals (A+B+C) x 2 - Total maximum = 20
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- other: sodium hydroxide 0.95%
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0.89
- Max. score:
- 1
- Reversibility:
- fully reversible
- Remarks on result:
- other: sodium hydroxide 0.95%
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- not reversible
- Remarks on result:
- other: sodium hydroxide 0.95%
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 2.22
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 8 d
- Remarks on result:
- other: sodium hydroxide 0.95%
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 2.25
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: sodium hydroxide 4.9%
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Remarks on result:
- other: sodium hydroxide 4.9%
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 2.63
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: sodium hydroxide 4.9%
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 2.33
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks on result:
- other: sodium hydroxide 4.9%
Applicant's summary and conclusion
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.