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EC number: 224-699-9 | CAS number: 4454-16-4
- 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
Skin irritation: Not irritating to the skin.
Eye irritation: Not irritating to the eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April-May 2015
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Deviations:
- yes
- Remarks:
- : A standard deviation of 18.5% concerning the viability of the negative control was recorded instead of 18%.
- Qualifier:
- according to guideline
- Guideline:
- other: Test method B.40bis Council regulation n°440/2008
- GLP compliance:
- yes (incl. QA statement)
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 3 minutes and 1 hour exposure
- Observation period:
- Not applicable
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 132.9
- Remarks on result:
- other: 3 minutes exposure
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 92.55
- Remarks on result:
- other: 1 hour exposure
- Interpretation of results:
- other: not corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In accordance with Regulation EC 1272/2008, the test item does not have to be classified in category 1 'Corrosive'.
Nickel 2-ethylhexanaote does not have to be classified also as 'Corrosive' according to the criteria for classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. - Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May - June 2015
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 4-hours
- Observation period:
- 1 hour and then 24, 48 and 72 hours after removal of the patch
- Number of animals:
- 3 animals
- Irritation parameter:
- erythema score
- Basis:
- other: mean animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- other: mean animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- erythema score
- Basis:
- other: mean animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- edema score
- Basis:
- other: mean animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- other: mean animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: between day 7 and day 14
- Irritation parameter:
- edema score
- Basis:
- other: mean animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Other effects:
- On the cutaneous structure, roughness ans loss of litheness was noted in one animal on day 7. The skin recovered a normal aspect on day 14. On the last day (day 14), dryness of the skin was noted in the two other animals.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item does not have to be classified.
Referenceopen allclose all
The mean viability of epidermis skins treated with the positivecontrol item (potassium hydroxide 8N) was 8.28% and 0.52% respectively 3 minutes and 1 hour after the application.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April-May 2015
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- The test item was previously out on a gauze which was applied on the eye to cover the entire surface of the cornea. The test item was applied for 10 seconds and then rinsed from the eye with 20 mL of physiological saline at ambient temperature.
- Observation period (in vivo):
- Treated corneas are evaluated pretreatment and starting at 30, 75, 120, 180 and 240 minutes (+/- 5 min.) after the post-treatment rinse.
- Irritation parameter:
- cornea opacity score
- Value:
- 0
- Remarks on result:
- other: maximal mean score = 0.0 corresponding to ICE class I
- Irritation parameter:
- fluorescein retention score
- Value:
- 2.3
- Remarks on result:
- other: maximal mean score = 2.3 corresponding to ICE class III
- Irritation parameter:
- corneal swelling
- Value:
- 8
- Remarks on result:
- other: maximal mean = + 8% corresponding to ICE class II
- Other effects / acceptance of results:
- Corneal opacity: maximal mean score = 0.0 corresponding to ICE class I
Fluorescein retention: maximal mean score = 2.3 corresponding to ICE class III
Corneal swelling: maximal mean = + 8% corresponding to ICE class II
Combination of the 3 endpoints: 1 x III, 1 x II, 1 x I - Interpretation of results:
- other: not corrosive/severe irritant
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- In accordance with Regulation EC 1272/2008, the test item does not have to be classified in category 1 'Irreversible effects on the eye'.
Nickel 2-ethylhexanaote does not have to be classified also R41 'Risk of serious damage to eyes' according to the criteria for classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directives 67/548, 2001/59 and 99/45. - Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May-June 2015
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 0.1 g of the test item was instilled, as supplied, into the conjunctival sac of one eye.
- Observation period (in vivo):
- Ocular examinations were performed on both eyes 1 hour, 24, 48 and 72 hours following treatment.
- Number of animals or in vitro replicates:
- 3 animals
- Irritation parameter:
- chemosis score
- Basis:
- other: mean animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- other: mean animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- other: mean animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: conjunctivae - redness
- Basis:
- other: mean animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- other: conjunctivae - redness
- Basis:
- other: mean animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: between day 1 and day 2
- Irritation parameter:
- other: conjunctivae - redness
- Basis:
- other: mean animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: between day 1 and day 2
- Irritation parameter:
- iris score
- Basis:
- other: mean animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- other: mean animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- other: mean animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean animal #1
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean animal #2
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- other: mean animal #3
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: not applicable
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item does not have to be classified.
Referenceopen allclose all
The combination of the 3 endpoints for the positive control, sodium hydroxide, was 3 x IV. Therefore the positive control is classified as 'Corrosive/severe irritant' as expected.
The combination of the 3 endpoints for the negative control, physiological saline, was 3 x I. Therefore the negative control as 'No category' as expected.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Key study
Justification for selection of eye irritation endpoint:
Key study
Justification for classification or non-classification
Skin corrosion:
Reference Colas (2015a) is considered as the key study for skin corrosion and will be used for classification. The overall irritation results are as follows:
- relative viability 3 minutes after treatment: 132.90%
- relative viability 1 hour after treatment: 92.55%.
The classification criteria according to regulation EC 1272/2008 as corrosive to the skin are not met since the relative viability after 3 minutes and 1 hour was above 50% and 15% respectively, hence no classification is required.
Skin irritation:
Reference Colas (2015b) is considered as the key study for skin irritation and will be used for classification.
According to the Acute dermal irritation test, the overall irritation results 24 - 48 and 72 hours after application per animal are as follows:
- erythema and eschar: 1.0 - 1.3 - 1.3;
- oedema: 0.0 - 2.0 - 0.0.
Results do not meet the criteria for classification (mean value ≥ 2.0 for one endpoint for all animals or for the 2 endpoints in at least 2 animals) according to regulation (EC) 1272/2008 as skin irritant, hence no classification required.
Eye irritation:
The references Colas (2015) are considered as the key studies for severe eye irritation and will be used for classification
According to the Isolated chicken eye test method, the ocular reactions observed were:
- maximal mean score of corneal opacity: 0.0 corresponding to ICE class I;
- maximal mean score of fluorescein retention: 2.3, corresponding to ICE class III;
- maximal mean corneal swelling: + 8%, corresponding to ICE class II.
The combination of the three endpoints does not meet classification criteria according to regulation EC 1272/2008 as severe eye irritation. No classification is required.
According to the Acute eye irritation test, the overall irritation results 24 - 48 and 72 hours after application per animal are as follows:
- corneal opacity = 0.0 for all three animals,
- iris lesion = 0.0 for all three animals,
- conjunctivae redness = 0.0 - 0.3 - 0.3,
- conjunctival oedema (chemosis) = 0.0 for all three animals.
The classification criteria according to regulation EC 1272/2008 as irritating to the eyes are not met, since the value for conjunctival redness was below the threshold of ≥ 2 as well as the effect was fully reversible. Hence, no classification is required.
Respiratory irritation:
The available data do not allow any conclusion on respiratory irritation.
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