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EC number: 215-671-7 | CAS number: 1340-06-3
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- start 23 June 1997
termination 27 June 1997 - Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- The OECD guideline for Testing of Chemicals No. 405, adopted February 24th, 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ichthyolic acid, sodium salt
- EC Number:
- 215-671-7
- EC Name:
- Ichthyolic acid, sodium salt
- Cas Number:
- 1340-06-3
- IUPAC Name:
- Identification of the UVCB substance by "Chemcial Abstracts Index Name", among others: Ichthyolic Acid, Sodium Salt. No IUPAC name known.
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- ICHTHYOL PALE from regular production at the registrant's manufacturing site (batch 960045) in a 5% buffered aqueous solution.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- Species/strain/stock/breeder
rabbit/Himalayan/CHR. FRED LEUSCHNER & CO., D-24601 Löhndorf/Post Wankendorf
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml test substance (Ichthyol Pale)/animal
- Concentration (if solution): 5%
- Duration of treatment / exposure:
- single instillation into the conjunctival sac
- Observation period (in vivo):
- Examination of eyes prior to the administration and 1, 24, 48 and 72 hours after the administration.
Animals that did not reveal any lesions anymore for 24 hours following the first 72 hours of observation were sacrificed. - Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no removal of test substance by washing or other measures
SCORING SYSTEM:
CORNEA
Opacity: degree of density (area most dense taken for reading)
0 no ulceration or opacity
1 scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible
2 easily discernible translucent area, details of iris slightly obscured
3/4 defined but not relevant for this study
IRIS
0 normal
1 markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 no reaction to light, haemorrhage, gross destruction (any or all of these)
CONJUNCTIVAE
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris)
0 blood vessels normal
1 some blood vessels definitely hyperaemic (injected)
2 diffuse, crimson colour, individual vessels not easily descernible
3 diffuse beefy red
Chemosis: lids and/or nictitating membrane
0 no swelling
1 any swelling above normal (including nictitating membranes)
2 obvious swelling with partial eversion of lids
3/4 defined but not relevant for study results
Any further lesions are listed.
TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein (after 24 hours)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Measurements of the cornea opacity score were conducted after one hour already. Also after one hour the score was 0.
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Remarks:
- Measurement of iris score was conducted after 1 h already. Score after 1 h: 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Remarks:
- Measurement of conjunctival redness score was conducted after 1 h already. Score after 1 h: 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Measurement of chemosis score was conducted after 1 h already. Score after 1 h: 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Measurement of opacity score was conducted after 1 h already. Score after 1 h: 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Measurement of opacity score was conducted after 1 h already. Score after 1 h: 0
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Remarks:
- Measurement of iris score was conducted after 1 h already. Score after 1 h: 0
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Remarks:
- Measurement of iris score was conducted after 1 h already. Score after 1 h: 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Remarks:
- Measurement of conjunctival redness score was conducted after 1 h already. Score after 1 h: 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Remarks:
- Measurement of conjunctival redness score was conducted after 1 h already. Score after 1 h: 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Measurement of chemosis score was conducted after 1 h already. Score after 1 h: 0
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Remarks:
- Measurement of chemosis score was conducted after 1 h already. Score after 1 h: 0
- Irritant / corrosive response data:
- Information given in the "results" section
- Other effects:
- 24 hrs fluorescein test: no pathological findings
No systemic intolerance reactions.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Ichthyolic Acid, Sodium Salt (ICHTHYOL PALE) was tested on its eye irritation potential according to OECD guideline 405. Under the test conditions a single application of 0.1 ml 5% Ichthyol Pale per animal into the conjunctival sac of the right eye of three rabbits did no cause any changes. The cornea, iris and conjunctivae were not affected by instillation of the test compound. There were no systemic intolerance reactions.
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