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Diss Factsheets
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EC number: 262-774-8 | CAS number: 61417-49-0
- 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
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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Deviations:
- no
- Principles of method if other than guideline:
- 0.5 ml under gauze dressing to the clipped intact skin of adult albino rabbits for a period of 4 hr with observations for erythema and edma at 4, 24, 48 and 72 hr. Score of 5 or more is considered a primary irritant.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Ken-React KR TTS
Lot R-1082S - Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hr.
- Observation period:
- 4, 24, 48 and 72 hr
- Number of animals:
- 6
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0.3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Remarks on result:
- no indication of irritation
- Other effects:
- Non observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The target substance is not irritating to skin with irritation score of 0.3.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Justification for type of information:
- As there is an in vivo study available, the in vitro study is not needed.
Referenceopen allclose all
E
Erythema & Eschar | ||||||
Animal # | 1 | 2 | 3 | 4 | 5 | 6 |
4 hr | 1 | 1 | 1 | 1 | 1 | 1 |
24 hr | 1 | 1 | 1 | 0 | 0 | 0 |
48 hr | 0 | 0 | 0 | 0 | 0 | 0 |
72 hr | 0 | 0 | 0 | 0 | 0 | 0 |
Edema score
0 for animals during the test.
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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Ken-React KR TTS Lot 22059
Reddish-brown liquid - Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- 1 hr
- Observation period (in vivo):
- 24, 48, 72 hr
- Number of animals or in vitro replicates:
- 3 animals. 1 male, 2 females
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1 hr
- Score:
- ca. 10
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- ca. 0.7
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- ca. 0
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- ca. 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The target substance is classified as minimally irritating to the eye.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Justification for type of information:
- As there is an in vivo study available, the in vitro study is not needed.
Referenceopen allclose all
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
Two in vivo studies were available for the target substance and both indicated non-irritant to skin and eyes (Prince, 1986, & Wnorowski 2003). The hydrolysis product isostearic acid also produced no significant skin or eye irritation in Draize rabbit irritation tests (CIR, 1983).
Based these findings, there is no need to classify the target substance as irritant to skin and eyes.
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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