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Diss Factsheets
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EC number: 254-372-6 | CAS number: 39236-46-9
- 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 test substance proved non-irritating to rabbit skin and caused only minor, fully reversible reactions in rabbit eyes.
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:
- other: Brief report of an open-site skin irritation study, with sufficient information to conclude an effective absence of irritation.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Evaluation of irritant action on intact and abraded skin, using an open test site with immobilisation of test animals.
- GLP compliance:
- no
- Remarks:
- Pre-GLP study
- Species:
- rabbit
- Strain:
- other: Described as albino rabbits.
- Details on test animals or test system and environmental conditions:
- No further information available.
- Type of coverage:
- open
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5g/test site.
- Duration of treatment / exposure:
- 24h
- Observation period:
- Skin reactions scored 24h and 72h after start of the exposure period.
- Number of animals:
- 3 rabbits
- Details on study design:
- Areas of intact and abraded (to penetrate stratum corneum only) skin were treated on each rabbit.
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24h and 72h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No signs of irritation observed.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24h and 72h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No signs of irritation observed.
- Irritant / corrosive response data:
- No evidence of irritation was observed.
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Open-site application of 0.5g test substance produced no evidence of skin irritation in this study.
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:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Report of a study using a standard test method and with full detail of individual animal results.
- Qualifier:
- according to guideline
- Guideline:
- other: US Federal Register 29 (1964), section191.12
- GLP compliance:
- no
- Remarks:
- Pre-GLP study
- Species:
- rabbit
- Strain:
- other: described as albino rabbits
- Details on test animals or tissues and environmental conditions:
- Further details not available.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- the lesser of 100 mg or 0.1 ml compacted volume.
- Duration of treatment / exposure:
- Applied and then scored after 24, 48 and 72h.
- Observation period (in vivo):
- 24, 48 and 72h post-treatment.
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- Test substance placed into a cup formed by gently pulling the lower eye lid, then eyelids held together for one second. One eye/animal treated, the other serving as control.
Corneal, conjunctival and iridial reactions scored after 24, 48 and 72h. - Irritation parameter:
- cornea opacity score
- Basis:
- other: all 6 test animals
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No reactions seen
- Irritation parameter:
- iris score
- Basis:
- other: all 6 test animals
- Time point:
- other: 24, 48 and 72h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: No reactions seen
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0.67
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48h
- Score:
- 0.17
- Max. score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: full recovery by this observation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24h
- Score:
- 0.17
- Max. score:
- 1
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48h and 72h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: full recovery by the 48h observation
- Irritant / corrosive response data:
- No corneal or iridial reactions were seen.
Transient conjunctival redness was seen in 4 test rabbits: mean score 24+48+72h across all 6 animals = 0.28, maximum score at any observation =1.
A single observation of chemosis was recorded (one animal, 24h only). - Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In this study only minor and transient conjunctival reactions were seen, following instillation of test substance into rabbit eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation tests included evaluation of effects on abraded skin as well as intact skin: only 24h occluded application of an aqueous 50% solution produced evident skin reaction. Tests with an intact skin barrier found no local reaction.
No major or irreversible reactions followed instillation into rabbit eyes.
A complete absence of skin reaction after 24h occluded application of test substance (at concentrations up tp 20% on water) to human volunteer subjects was seen, leading to a conclusion that the substance was non-irritating to human skin.
Justification for selection of skin irritation / corrosion endpoint:
The available studies demonstrate an absence of irritant effect on rabbit skin.
Justification for selection of eye irritation endpoint:
In the key study, minor and transient conjunctival reactions (maximum score 1, fully recovered by 3 days post-treatment) were seen in 4/6 test animals.
Justification for classification or non-classification
The reported absence of local effect on rabbit skin and minor effect shortly after instillation into rabbit eyes lead to the conclusion that no classification in respect of irritant action is warranted (under either CLP Regulation criteria or the older DSD rules).
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