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EC number: 610-641-3 | CAS number: 512802-65-2
- 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
The results of a reliable in vitro skin corrosion and a reliable in vitro skin irritation study employing human skin tissue (eipdermis keratinocytes) exposed to the undiluted substance indicates that the substance is non-corrosive and non-irritant to human skin.
A structurally similar substance produced a primary irritation index of 0.0 in a reliable in vivo study performed to assess the irritancy potential of the substance to the skin of New Zealand White rabbit. The substance is classified as a non-irritant according to Draize classification scheme.
A structurally similar substance produced a maximum group mean score of 10.0 in a reliable in vivo study performed to assess the irritancy potential of the substance to the eye of New Zealand White rabbit. The substance is classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
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:
- 21 January 2016 to 22 January 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- 28 July 2015
- Deviations:
- yes
- Remarks:
- An additional procedure using freeze-killed tissues was performed, but the results of this was not used because there was negligible interference. This deviation was considered not to affect the purpose or integrity of the study.
- GLP compliance:
- yes
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Source strain:
- not specified
- Justification for test system used:
- As specified in the OECD Guidelines for this type of testing.
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 3-minutes
60-minutes - Number of replicates:
- Duplicate tissues were exposed to the substance for each time point. The MTT assays were conducted in triplicates.
- Vehicle:
- unchanged (no vehicle)
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3-minute exposure
- Value:
- 88.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60-minute exposure
- Value:
- 103.7
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was considered to be non-corrosive to the skin.
- Executive summary:
In an in vitro skin corrosion study human skin tissue (epidermis keratinocytes) was exposed to the undiluted substance for 3-minutes and 1-hour. There was 88.8% and 103.7% tissue viability following the 3-minutes and 1-hour exposure points, respectively. Resultantly, the substance is considered to be non-corrosive to skin.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 February 2016 to 22 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- GLP compliance:
- yes
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Duration of treatment / exposure:
- 15-Minute exposure period
- Duration of post-treatment incubation (if applicable):
- 42-Hour post-exposure incubation period.
- Number of replicates:
- Triplicate
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 84.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance was classified as a non-irritant.
- Executive summary:
In an in vitro skin irritation study human skin tissue (epidermis keratinocytes) was exposed to the undiluted substance for 15-minutes. There was 84.2% tissue viability following the 15-minute exposure point. Resultantly, the substance is considered to be a non-irritant to human skin.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Read-across to K1 study therefore K2 is the maximum Klimisch value.
- Justification for type of information:
- Read-across approach - see read-across justification in section 13.
- Reason / purpose for cross-reference:
- read-across source
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml of undiluted test material was applied.
- Duration of treatment / exposure:
- 1 hour and 3 minute exposure periods
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: Dorsal / flank area
- % coverage: 2.5 X 2.5 cm
- Type of wrap if used: Cotton gauze patch secured with a surgical adhesive tape.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton wool soaked in distilled water.
SCORING SYSTEM: Draize Classiification Scheme - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 hour
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Max. score is 4 for erythema and 4 for edema.
- Irritant / corrosive response data:
- No evidence of skin irritation was noted during the study.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- The substance produced a primary irritation index of 0.0 and was classified as a non-irritant according to Draize classification scheme.
- Executive summary:
An in vivo study was performed to assess the irritancy potential of the substance to the skin of New Zealand White rabbit according to OECD TG 404 (Acute Dermal Irritation/Corrosion). A single 4 -hour, semi-occluded application of the substance to the intact skin of 3 rabbits produced no evidence of skin irritation. Three-minute and 1 -hour semi-occluded applications of the substance to the intact skin of 1 rabbit produced no evidence of skin irritation. The substance produced a primary irritation index of 0.0 and therefore classified as non-irritant to rabbit skin according to the Draize classification scheme.
Referenceopen allclose all
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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Read-across to K1 study therefore K2 is the maximum Klimisch value.
- Justification for type of information:
- Read-across approach - see read-across justification in section 13.
- Reason / purpose for cross-reference:
- read-across source
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Untreated eye was used as control
- Amount / concentration applied:
- undiluted
Amount applied: 0.1 ml - Observation period (in vivo):
- 1, 24, 48 and 72 hour
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24 hrs
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted in all treated eyes at the 24h-observation. Treated eyes appeared normal at the 48-hour and 72-hour observation.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance produced a maximum group mean score of 10.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The substance did not meet the criteria for classification according to EU labelling.
- Executive summary:
The irritatncy potential of the substance to the eye of New Zealand White rabbit was assessed according to the OECD TG 405 (Acute Eye Irritation/Corrosion). In the absence of skin irritation data a Rabbit Enucleated Eye Test was performed prior to the in vivo study and the results from this study indicated that the substance qwas unlikely to cause severe ocular irritancy. A single application of the substance to the unwashed eye of three rabbits produced moderate conjunctival irritation. All treated eyes appeared normal at the 48-hour observation. the substance produced a maximum group mean score of 10.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
Reference
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
Based on the findings of reliable studies conducted on the substance and a structural analogue, classification of the substance is not justified.
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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