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EC number: 943-938-4 | CAS number: 28214-91-7
- 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
Six rabbits were exposed to the test substance dermally for 24 hours under occlusion (PSL 1981 (1), PSL 1981 (2)). The test substance initiated irritation of the skin at 24 and 72 h observations. This irritation was not shown to be reversible. Therefore the test substance is classified as skin irritant category 2.
Eye irritation
Six rabbits were treated with the test substance in an eye irritation test (PSL 1981 (1), PSL 1981 (2)). During the observation period of 72 hours severe eye irritation was reported (including effects on cornea), which was not shown to be reversible within 72 hours. In view of the absence of effects on the iris and a mean maximum overall score of 1.3 for cornea, it was concluded that the test substance is a category 2 eye irritant.
Studies on skin and eye irritation toxicity are available on DNNSA and BaDNNSA. These studies are indicative of moderate to severe irritation and therefore show that both DNNSA and BaDNNSA are suitable candidates for read-across.
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
- Study period:
- january 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: limited report, non-GLP, results are indicative for irritation and represent a worst case (24 h exposure under occlusion). The information in the report is limited to the information in the summary.
- Qualifier:
- according to guideline
- Guideline:
- other: FHSLA 16 CFR 1500
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Cedar Knoll
- Age at study initiation: not indicated
- Weight at study initiation: no data
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 °C
- Humidity (%): not indicated
- Air changes (per hr): not indicated
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped and abraded
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration (if solution): 50% in diluent oil - Duration of treatment / exposure:
- 24 hours
- Observation period:
- scored at 24 and 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm2 (two times, one for clipped skin, other for abraded skin)
- Type of wrap if used: occlusive, rubberized elastic cloth
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
SCORING SYSTEM: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 4
- Remarks on result:
- other: non-abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 3.86
- Reversibility:
- not reversible
- Remarks on result:
- other: non-abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24
- Score:
- 3
- Remarks on result:
- other: non-abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 0.83
- Reversibility:
- not reversible
- Remarks on result:
- other: non-abraded skin
- Irritant / corrosive response data:
- irritant
- Other effects:
- none reported
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is irritating to the skin
- Executive summary:
Six rabbits were exposed to the test substance dermally for 24 hours under occlusion. The test substance initiated irritation of the skin at 24 and 72 h observations. This irritation was not shown to be reversible. Therefore the test substance is classified as skin irritant category 2.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- january 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: limited report, non GLP, effects were not shown to be reversible, The information in the report is limited to the information in the summary.
- Qualifier:
- according to guideline
- Guideline:
- other: FHSLA 16 CFR 1500
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Cedar Knoll
- Age at study initiation: young adult
- Weight at study initiation: not reported
- Housing: individually
- Diet: Fisher Rabbit Pellets ad libitum
- Water: ad libitum
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22 °C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.1 mL
- Concentration (if solution): 50% - Observation period (in vivo):
- scored 24, 48 and 72 hours after application
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: not indicated - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 2.7
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Remarks:
- discharge
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 1.6
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24-72 h
- Score:
- ca. 2.6
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 hours
- Irritant / corrosive response data:
- irritant
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance induced eye irritation
- Executive summary:
Six rabbits were treated with the test substance in an eye irritation test. During the observation period of 72 hours severe eye irritation was reported, which was not shown to be reversible. In view of the absence of effects on the iris and a mean overall score of 1.3 for cornea, it was concluded that the test substance is a category 2 eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The available studies contain sufficient information to be used for classification and labelling.
Justification for selection of skin irritation / corrosion endpoint:
Studies were conducted prior to GLP regulations but used methods generally consistent with accepted procedures. Two studies of equal quality are available. Both can be indicated as key-study. The results of both studies are comparable.
Justification for selection of eye irritation endpoint:
Studies were conducted prior to GLP regulations but used methods generally consistent with accepted procedures. Two studies of equal quality are available. Both can be indicated as key-study. The results of both studies are comparable
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: moderately irritating
Justification for classification or non-classification
Based on the outcome of the available tests, the test substance needs to classified as skin irritant (CLP category 2, H315: Causes skin
irritation) and severe eye irritant (CLP category 2, H319: Causes serious eye irritation).
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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