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EC number: 431-540-9 | CAS number: 170573-32-7
- 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
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: 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
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Source: "l'elevage Cunicole de Val de Seile, 80160 Prouzel, France"
Acclimation: at least 5 days
Weight: 2.6 +/- 0.2 kg
Temperature: 20 +/- 3°C
Relative humidity: 50 +/- 20%
Light period: 12h light / 12h dark
Feed: "Lapins entretien reference 112 C" (U.A.R., 91360 Villemoisson-Sur-Orge, France), ad libitum
Water: filtered tap water, ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL in the conjunctival sac of the left eye
- Duration of treatment / exposure:
- One application
- Observation period (in vivo):
- 1, 24, 48 and 72h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Eye reactions were evaluated and scored (0 - 4) for chemosis (lids), eye watering and redness (conjunctive tissues, cornea and iris).
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: after 1 h
- Score:
- >= 0 - <= 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- other: chemosis, enanthema and redness
- Irritation parameter:
- other: eye watering
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 24 h
- Remarks on result:
- not determinable
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Some slight conjunctival reactions (chemosis with a score < or = to 1, enanthema with a score of 1 to 2, and redness with a score of < or = to 1.3) were observed in the 3 rabbits after 1h. Neither iris irritation nor corneal opacity were recorded. Reactions were fully reversible; no effects were seen at 24, 48 and 72h.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance was not considered to be irritating to rabbit eye.
- Executive summary:
A study was conducted to determine the eye irritation potential of the test substance, isoC18 MIPA (purity not specified), according to EU Method B.5, in compliance with GLP. Three male rabbits (New-Zealand White) received 0.1 mL of the undiluted test substance in the conjunctival sac of the left eye. The right eye remained untreated and served as control. Observations were made at 1, 24, 48 and 72 h. Eye reactions were evaluated and scored (0 - 4) for chemosis (lids), eye watering and redness (conjunctive tissues, cornea and iris). Some slight conjunctival reactions (chemosis with a score of ≤ 1 and enanthema with a score of 1 to 2) were observed in the 3 rabbits after 1 h. Neither iris irritation nor corneal opacity were recorded. Reactions were fully reversible; no effects were seen at 24, 48 and 72 h. Under the study conditions, the test substance was not considered to be irritating to rabbit eye (Clouzeau, 1992).
Referenceopen allclose all
None.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
A study was conducted to determine the skin irritation / corrosion potential of the test substance, isoC18 MIPA (purity not specified), according to EU Method B.4, in compliance with GLP. Three male rabbits (New Zealand White) were exposed for 4 h to 0.5 mL undiluted test substance, under a semiocclusive bandage. The left flank remained untreated and served as control. Observations were made at 1, 24, 48 and 72 h and daily thereafter (for 9 d). Skin reactions (erythema and oedema) were evaluated using the Draize scoring and measured after 24, 48 and 72 h. Significant skin reactions were observed for at least 48 h in the 3 animals. These erythema reactions persisted for 72 h after treatment (mean scores of 1.7, 2.0 and 2.0 in each animal). No oedema was observed. From Day 5, the erythema decreased and disappeared on Day 8. A darkness of the skin persisted until Day 8. Under the study conditions, the test substance was considered to be irritating to rabbit skin but not sufficiently to trigger classification according to CLP (EC 1272/2008) criteria (Clouzeau, 1992).
Eyes
A study was conducted to determine the eye irritation potential of the test substance, isoC18 MIPA (purity not specified), according to EU Method B.5, in compliance with GLP. Three male rabbits (New-Zealand White) received 0.1 mL of the undiluted test substance in the conjunctival sac of the left eye. The right eye remained untreated and served as control. Observations were made at 1, 24, 48 and 72 h. Eye reactions were evaluated and scored (0 - 4) for chemosis (lids), eye watering and redness (conjunctive tissues, cornea and iris). Some slight conjunctival reactions (chemosis with a score of ≤ 1 and enanthema with a score of 1 to 2) were observed in the 3 rabbits after 1 h. Neither iris irritation nor corneal opacity were recorded. Reactions were fully reversible; no effects were seen at 24, 48 and 72 h. Under the study conditions, the test substance was not considered to be irritating to rabbit eye (Clouzeau, 1992).
Justification for classification or non-classification
Skin
Based on the results of an in vivo study, classification for skin irritation as XXXX is warranted for the test substance according to CLP (EC 1272/2008) criteria.
Eye
Based on the results of an in vivo study, no classification for eye irritation is required for the test substance according to CLP (EC 1272/2008) criteria.
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