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EC number: 257-768-7 | CAS number: 52236-73-4
- 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
Endpoint summary
Administrative data
Description of key information
Eye irritation: not irritating
Skin irritation: not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- Experimental study performed on the non-salified form of the substance under registration. The difference in counter-ion does not impact the study outcomes because the ecotoxicological properties are determined by the base of the substance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Spolkem chovatelů z Hradce Králové.
- Weight at study initiation: 2.5 kg.
- Housing: housed individually in metal cages.
- Diet: pelleted standard commercially manufactured compound KO-16, supplied by s.p. Velaz Prague.
- Water: ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Relative humidity: 50 ± 15 %
- Photoperiod: 12 hrs dark / 12 hrs light - Type of coverage:
- occlusive
- Preparation of test site:
- other: scarified and intact shaved skin
- Vehicle:
- water
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
- Application: as aqueous paste. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- Three rabbits
- Details on study design:
- TEST SITE
- Area of exposure: a day before the application, experimental rabbits were depilated on the left and right lateral surface (are 6 x 6) of the abdominal area; the skin of the right side was scarified.
- Type of wrap if used: gauze was covered by aluminum foil and cellulose wadding. Bandage was fixed by technical tape.
OBSERVATION TIME POINTS
Dermatological skin diagnostics was perfromed focusing on the symptoms of erythema, edema at 4, 24, 48 and 72 hours. The degree of erythema was diagnosed by visual check and palpation. Additional clinical examination was carried out at 24, 48 and 72 hours. - Irritation parameter:
- erythema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Reversibility:
- fully reversible within: 24 hrs
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Reversibility:
- fully reversible within: 24 hrs
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritating
- Executive summary:
Method
The skin irritation potential of the substance was determined following the testing procedures outlined into the OECD guideline 404. 0.5 g of test substance were placed on both intact and scarified skin, as aqueous paste. Three rabbits were used.
After 24 hours of exposure the bendage was removed and the reactions scored.
Result
The primary irritation score was 0
Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema and oedema reactions (in both intact and scarified skin).
Reference
Animal N. | Reaction | After 4 hrs | After 24 hrs | After 48 hrs | After 72 hrs | ||||
Inact skin | Scarified skin | Inact skin | Scarified skin | Inact skin | Scarified skin | Inact skin | Scarified skin | ||
22 | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
28 | Erythema | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
29 | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
22 | Oedema | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
28 | Oedema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
29 | Oedema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- Experimental study performed on the non-salified form of the substance under registration. The difference in counter-ion does not impact the study outcomes because the ecotoxicological properties are determined by the base of the substance. Reliability of the source study is 2
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Spolkem chovatelů z Hradce Králové.
- Weight at study initiation: 2.5 kg.
- Housing: housed individually in metal cages.
- Diet: pelleted standard commercially manufactured compound KO-16, supplied by s.p. Velaz Prague.
- Water: ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3 °C
- Relative humidity: 50 ± 15 %
- Photoperiod: 12 hrs dark / 12 hrs light - Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g
- Application: the substance was introduced in conjunctival sac. The upper and lower lids were maintained closed for few seconds, to avoid loss of the test substance. - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Three rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: with drinking water.
- Time after start of exposure: 24 hours.
SCORING SYSTEM:
The reactions observation was performed at 1, 24, 48 and 72 after substance application. 1 hour after the instillation of ocular reactions were assessed without flushing of the eye with drinking water. Reaction at 48 hours were scored without the usage of fluorescein.
TOOL USED TO ASSESS SCORE: fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 1
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- other:
- Conclusions:
- Not irritating
- Executive summary:
Method
The eye irritation potential of the substance was determined following the testing procedures outlined into the OECD guideline 405. 0.1 g of test substance were placed into conjunctival sac of three rabbits. After 24 hours of exposure the substance was removed using drinking water.
Result
The primary irritation score was 2
The mean values from gradings at 24, 48 and 72 hours were lower than 1 for corneal opacity, lower than 1 for irtitis, lower than 2 for both conjunctival redness and oedema, in all animals.
Reference
Animal N. | Time score (hrs) | Cornea | Iris | Conjunctival | |||
Opacity | Area | Redness | Chemosis | Discharge | |||
22 | 1 | 0 | 0 | 0 | 1 | 0 | 2 |
24 | 0 | 0 | 0 | 0 | 0 | 1 | |
48 | 0 | 0 | 0 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 | 0 | 0 | 0 | |
28 | 1 | 0 | 0 | 0 | 1 | 0 | 1 |
24 | 0 | 0 | 0 | 1 | 0 | 0 | |
48 | 0 | 0 | 0 | 1 | 0 | 0 | |
72 | 0 | 0 | 0 | 0 | 0 | 0 | |
29 | 1 | 0 | 0 | 0 | 2 | 0 | 1 |
24 | 0 | 0 | 0 | 1 | 0 | 0 | |
48 | 0 | 0 | 0 | 1 | 0 | 0 | |
72 | 0 | 0 | 0 | 1 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), 3.2 Skin corrosion/irritation section, skin Irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
Based on the available information, the substance can be considered as not skin irritating.
According to the CLP Regulation (EC 1272/2008), 3.3 serious eye damage/eye irritation section, eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application.
Based on the available information, the substance can be considered as not eye irritating.
In conclusion, the substance is not classified for the eye/skin irritation, according to the CLP Regulation (EC 1272/2008).
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.
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