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EC number: 247-019-2 | CAS number: 25481-21-4
- 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:
No signs of dermal irritation were observed in the 26 volunteers treated with the test chemical as compared to the 21 of 26 volunteers treated with SDS. Hence the test chemical was considered to be not irritating to human skin and it can be classified under the category “Not Classified”.
Eye Irritation:
No corneal opacity was observed in the rabbits at all observation times. Hence, the test chemical was considered to be not irritating to eyes. It can be classified under the category “Not Classified”.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
- Qualifier:
- according to guideline
- Guideline:
- other: Human patch test
- Principles of method if other than guideline:
- Patch tests were performed oh human volunteers to assess the dermal irritation potential of the test chemical
- GLP compliance:
- not specified
- Species:
- other: humans
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data available
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact skin
- Vehicle:
- water
- Controls:
- yes, concurrent positive control
- Amount / concentration applied:
- 0.2 g solid moistened
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48 and 72 hours
- Number of animals:
- 26
- Details on study design:
- TEST SITE
- Area of exposure: upper outer arm
- % coverage: 25 mm Plain Hill Top Chamber
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after exposure
SCORING SYSTEM: Treatment sites were assessed for the presence of irritation using a four point scale.
Grading of response
0 - No reaction
+ - Weakly positive reaction (usually characterized by mild erythema or dryness across most of the treatment site)
++ - Moderately positive reaction (usually distinct erythema possibly spreading beyond the treatment site)
+ + + - Strongly positive reaction (strong, often spreading erythema with oedema) - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- other: not irritatng
- Conclusions:
- No signs of dermal irritation were observed in the 26 volunteers treated with the test chemical as compared to the 21 of 26 volunteers treated with SDS.
Hence the test chemical was considered to be not irritating to human skin and it can be classified under the category “Not Classified”. - Executive summary:
Patch tests were performed oh human volunteers to assess the dermal irritation potential of the test chemical. 0.2 g of the test chemical on a 25 mm Plain Hill Top Chambers containing a Webril pad (moistened for solid test materials) to the skin of the upper outer arm of 26 human volunteers for up to 4 hours. To avoid the production of unacceptably high reactions, test materials are applied progressively from 15 and 30 min through 1, 2, 3 and 4 hours.
Treatment sites are assessed for the presence of irritation using a four point scaleat 24, 48 and 72hours after patch removal. 0.2 ml of20% Sodium dodecycl sulphate was used as a positive control.
No signs of dermal irritation were observed in the 26 volunteers treated with the test chemical as compared to the 21 of 26 volunteers treated with SDS.
Hence the test chemical was considered to be not irritating to human skin and it can be classified under the category “Not Classified”.
Reference
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:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
- Qualifier:
- according to guideline
- Guideline:
- other: as mentioned below
- Principles of method if other than guideline:
- To assess the ocular irritation potential of the test chemical in rabbits according to Draize method
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- no data available
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- no data available
- Duration of treatment / exposure:
- single exposure
- Observation period (in vivo):
- From 1 hour till 21 days after instillation of test chemical
- Duration of post- treatment incubation (in vitro):
- no data available
- Number of animals or in vitro replicates:
- 1
- Details on study design:
SCORING SYSTEM: Draize method
Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No corneal opacity was observed in the rabbits at all observation times.
- Interpretation of results:
- other: not irritating
- Conclusions:
- No corneal opacity was observed in the rabbits at all observation times. Hence, the test chemical was considered to be not irritating to eyes. It can be classified under the category “Not Classified”.
- Executive summary:
An eye irritation study in rabbits was conducted to assess the irritation potential of the test chemical.The study was performed according to Draize method. Undiluted test chemical was instilled in the eyes of 1 rabbit and observed for signs of irritation till 7 days. The reactions observed were scored according to Draize method.Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical.
No corneal opacity was observed in the rabbits at all observation times. Hence, the test chemical was considered to be not irritating to eyes. It can be classified under the category “Not Classified”.
Reference
Table: Draize eye test reference database
Physical state |
Purity |
Commercial source |
UN GHS category |
Number of animals |
Comments |
Solid |
≥99% |
Sigma –Aldrich |
NC |
NO DATA |
CO>0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
Study 1 :
Patch tests were performed oh human volunteers to assess the dermal irritation potential of the test chemical. 0.2 g of the test chemical on a 25 mm Plain Hill Top Chambers containing a Webril pad (moistened for solid test materials) to the skin of the upper outer arm of 26 human volunteers for up to 4 hours. To avoid the production of unacceptably high reactions, test materials are applied progressively from 15 and 30 min through 1, 2, 3 and 4 hours. Treatment sites are assessed for the presence of irritation using a four point scaleat 24, 48 and 72hours after patch removal. 0.2 ml of20% Sodium dodecycl sulphate was used as a positive control. No signs of dermal irritation were observed in the 26 volunteers treated with the test chemical as compared to the 21 of 26 volunteers treated with SDS.
Study 2 :
A Primary dermal irritation study was performed to assess the irritation potential of the test chemical in rabbits. The test chemical was applied as a 50% aqueous solution to the back skin of rabbits.The exposure time was 1, 5 and 15 minutes and 20 Hours on the back of the skin. Observation times 24 hours and 8 days after application. There were no irritation symptoms on the back skin at all observation times. Hence the test chemical was considered to be not irritating to skin.
Hence the test chemical was considered to be not irritating to human skin and it can be classified under the category “Not Classified”.
Eye Irritation:
Study 1 :
Based on the available studies for the closely related chemicals, the weight of evidence approach was applied to assess the ocular irritation potential of the nickel(II) EDTA complex. An eye irritation study in rabbits was conducted to assess the irritation potential of the test chemical. The study was performed according to the Draize method. An undiluted test chemical was instilled in the eyes of 1 rabbit and observed for signs of irritation till 7 days. The reactions observed were scored according to the Draize method. Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical. No corneal opacity was observed in the rabbits at all observation times. Hence, the test chemical was considered to be not irritating to the eyes. It can be classified under the category “Not Classified”.
Study 2 :
A Primary ocular irritation study was performed to assess the ocular irritation potential of the test chemical in rabbits. The test chemical was instilled in rabbit eyes and observed for signs of irritation (duration, dose and observation not mentioned). The test chemical was not irritating to rabbit eyes in a primary eye irritation study.
Based on the available data for the test chemicals it can be concluded that the target chemical will also tend to behave in a similar manner to that of the read-across substances. Therefore, Nickel(II) EDTA complex was estimated to be not irritating to the eyes and it can be further classified under the category “Not Classified” as per CLP regulation.
Justification for classification or non-classification
The results of the experimental studies from the closely related substances indicate a possibility that Nickel(II) EDTA complex can be not irritating to skin and eyes.
Hence by applying the weight of evidence approach and using read across substances, Nickel(II) EDTA complex can be considered to be not irritating to skin and eyes. Thus as per CLP criteria, it was found to be “Not Classified”.
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