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EC number: 284-716-0 | CAS number: 84962-20-9
- 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:
- Dec 1984 - Jan 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Knapsack-Reinigerkomponente GB
- IUPAC Name:
- Knapsack-Reinigerkomponente GB
- Test material form:
- other: liquid
- Details on test material:
- colorless liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River France, 76410 Saint Aubin les Elbeuf, France
- Weight at study initiation: 2483 g
- Housing: individually in polystyrene cages (0.35 x 0.55 x 0.32 m)
- Diet (e.g. ad libitum): pelleted Rabbit Diet SQC (Special Diets Services Ltd., Witham, Essex, G.B.), ad libitum
- Water (e.g. ad libitum): filtered tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 50 +/- 30%
- Photoperiod (hrs dark / hrs light): 12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the second eye served as control
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- The test substance was instilled into the inferior conjuncival sac of the left eye. During the treatment and 15 min later, the animals were maintained in restrainer cages. The eyes were not washed after application.
- Observation period (in vivo):
- 1 hour post application
24 hours post application
48 hours post application
72 hours post application
from day 4 to day 22 post application daily - Number of animals or in vitro replicates:
- 6
- Details on study design:
- The eyes were examined 1 hour daily until day 22 after application of the test substance.
After treatment the eyes were not washed out.
SCORING SYSTEM:
A. CORNEA
Degree of opacity (most dense area used)
No opacity ...................................................................................................................0
Scattered or diffuse areas, details of iris clearly visible........................................1
Easily discernible translucent areas, details of iris slightly obscured................2
Opalescent areas, no details of iris visible , size of pupil barely discernible ....3
Opaque, iris invisible, ulzeration ..............................................................................4
IRIS
Normal ......................................................................................................................... 0
Folds above normal , congestion, swelling, circumcorneal injection (any of all of these or combination of any thereof); iris still reacting to light
(sluggish reaction is positive) ......................... .........................................................1
No reaction to light, haemorrhage, gross destruction (any or all of these) ......2
CONJUNCTIVAE
A. Redness
Blood vessels normal...............................................................................................................0
Blood vessels definitely injected above normal ................................................................. 1
More diffuse, deeper crimson red, individual blood vessels not easily discernible .....2
Diffuse beefy red......................................................................................................................3
B. Chemosi s (refers to palpebral and bulbar conjunctivae)
No swelling .........................................................................................0
Any swelling above normal (includes nictitating membran) ..... 1
Obvious swelling with partial eversion of l i d s ...........................2
Swelling with lids about half closed ................................................3
Swelling with lids half closed to completely closed.......................4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- not determinable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Remarks on result:
- not determinable
- Remarks:
- due to opacity of cornea
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 4
- Remarks on result:
- not determinable
- Remarks:
- lids of the animals could not be opened
- Irritant / corrosive response data:
- refer to any other information on results
- Other effects:
- animal no. 2 was found dead on day 12 post application
Any other information on results incl. tables
From the first hour after instillation, reactions of the conjunctivae, congestion of the iris and opacity of the cornea were visible. From day 2 until the end of the study, the observation of the iris was not possible because of the opacity of the cornea. Discharge disappeared. All the other reactions still persisted.
From day 15 to day 22, chemosis only could be scored because the lids of the animals could not be opened.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- With reference the reported scores (chemosis: 4; redness: 2; opacity: 4 in all animals) and the irreversibility of the observed effects Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol has to be classified as irritant to the eyes (R41 - Risk of serious damage to the eyes; H318 - Causes serious eye damage) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
- Executive summary:
Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol was tested for its eye irritant properties in 6 New Zealand White rabbits.The study was performed according to OECD Guideline 405.
Effects on conjunctivae, iris and cornea (chemosis score: 4; redness score: 2; opacity score: 4) were observed in all animals one hour after application and persisted to the study termination after 22 days. One animal was found dead on day 12 post application.
With reference the reported scores and the irreversibility of the observed effects Phosphoric acid, mixed esters with Bu.Alc. and Ethylene glycol
has to be classified as irritant to the eyes (R41 - Risk of serious damage to the eyes; H318 - Causes serious eye damage) according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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