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EC number: 209-529-3 | CAS number: 584-08-7
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 984
- Report date:
- 1984
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA, Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959
- Principles of method if other than guideline:
- Draize Test
- GLP compliance:
- yes
Test material
- Reference substance name:
- Potassium carbonate
- EC Number:
- 209-529-3
- EC Name:
- Potassium carbonate
- Cas Number:
- 584-08-7
- Molecular formula:
- CH2O3.2K
- IUPAC Name:
- dipotassium carbonate
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: H. Fortkamp, 4540 Lengerich
- Age at study initiation: 11 -17 weeks, male
- Weight at study initiation: 2.57 - 2.85 kg
- Housing: individual in screen bottom cages
- Diet: ad libitum, Ssniff K, laboratory rabbit chow (Ssniff Versuchstier-Diäten GmbH, 4770 Soest/ Westfalen, Germany) ad libitum
- Water: tap water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23 °C
- Humidity (%): 40 - 70 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hours dark/light cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): instilled undiluted in the original state as delivered by the sponsor - Duration of treatment / exposure:
- eyes were not rinsed.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The animals were treated with the test article (as delivered by the sponsor), which was instilled into the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lid was then gently held together for about one to two seconds, afterwards animals were returned to their cages.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
- as stipulated by Draize 1959 and guideline for acute eye irritation of US Interagency Regulatory Liaison Group (IRLG) Testing Standards and Guidelines Work Group (January 1981)
READINGS:
- 1 hour, 1, 2, 3, 4 and 7 days after instillation of test substance
TOOL USED TO ASSESS SCORE:
- 24 hours before treatment eyes were examined for lesions after application of fluorescein 0.15 %.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1, 2, 6
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d (=end of observation period)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3, 4
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d (= end of observation period)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- iris score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 d (= end of observation period)
- Remarks:
- fully reversible for 50% of the animals
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 d (= end of observation period)
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1-6
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 d (= end of observation period)
- Irritant / corrosive response data:
- Moderate to serious effects on cornea, iris and conjunctiva were observed, but no clear proof that this is not reversible after 21 days was obtained.
Any other information on results incl. tables
Potash Eye Irritation mean values
Time point after treatment |
Mean Values |
|||
Cornea score opacity |
Iris score |
Conjunctiviae score |
||
redness |
chemosis |
|||
1 hour |
2,2 |
2 |
3 |
4 |
1day |
2,2 |
2 |
3 |
4 |
2 days |
2,2 |
2 |
3 |
4 |
3 days |
2,2 |
2 |
3 |
4 |
4 days |
1,8 |
1,7 |
3 |
3 |
7 days |
1,8 |
0,5 |
2,3 |
1,8 |
Remark: no observations was made after 7 days
Scoring system
Score |
Cornea score opacity |
Iris score |
Conjunctiviae score |
|
redness |
chemosis |
|||
1 |
no opacity |
normal |
no redness |
no swelling |
2 |
single, slight opacity |
morphologic changes |
slight redness |
slight swelling |
3 |
diffuse opacity |
tissue destruction |
clear redness |
clear swelling |
4 |
distinct opacity |
n.a. |
strong redness |
strong swelling |
n.a. = not applicable
Mean Total Scores (MTS) according to Kay and Calandra were calculated and used for classification by the study authors:
1h: MTS = 56.3
1d: MTS = 60.5
2d: MTS = 65.5
3d: MTS = 70.5
4d: MTS = 57.8
7d: MTS = 49.8
Maximum Mean Total Score (MMTS) possible: 110)
Based on these mean scores, the test item was considered to be seriously irritating by the study authors.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Classification is based on effects on the cornea, iris and conjunctiva calculated as mean scores following grading at 24, 48 and 72 hours after instillation of the test material. The observation time did not extend beyond 7 days, therefore the reversibility of the effects could not be evaluated. As conclusion from this study, there are indications of severe eye irritation but no clear proof that this is not reversible over 21 days.
- Executive summary:
In a primary eye irritation study according to FDA (Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics, 1959), the moistened test substance "potash-calc." was instilled into the conjunctival sac of 6 male New Zealand White rabbits. The eyes were not rinsed after substance application. Animals then were observed for 7 days. Irritation was scored by the method of Draize.
One hour after the application of the test item clear irritation of the eyes was observed. All animals showed conjunctival redness (mean score 3) and chemosis (mean score 4), accompanied by moderate secretion (score 2) and corneal opacity. In addition all animals developed an iritis. For all observed effects the mean scores decreased within the observation period of seven days. At day 7, all animals showed still slight to moderate conjunctival redness and slight to distinct chemosis, accompanied by secretion (score 1 or 3) in all but one animal. Corneal pannus formation was present in 2/6 animals. Five of the six animals had still an opacity of the cornea of different occurance (score 1 - 3). The iritis was completely reversible in 3/6 animals and had decreased in the other 3 animals to score 1 by day 7.
The observation time did not extend beyond 7 days, even though eye responses were still present at this time, since the test protocol followed did not demand a longer observation period at the time the study was performed. A decrease in severity of some effects was observed until study termination on day 7. No clear proof that the observed effects are not reversible after 21 days has been obtained.
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