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EC number: 266-369-7 | CAS number: 66469-15-6
- 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
According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for skin irritation.
According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for eye irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The source study was conducted with isooctadecanoic acid. The read across source substance is considered a structural analogue taking into account the physico-chemical properties (surface active properties, logKow, water solubility) and the chemical structure of the test item (potassium soap of isooctadecanoic acid). Besides published data on skin irritation properties of long chain fatty acids and their salts are considered relevant for this read across approach. The results of the source substance are considered relevant for human health endpoints skin irritation, eye irritation and consecutive risk assessment of local effects. See read across document for further details.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Name of test material (as cited in study report): Prisorine 3505 Acide Isostearique
Physical state: liquid
Analytical purity: no data
Other: light yellow - Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- other: untreated sites of the same animal served as control
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 5 hours after removal of the dressing and 24, 48, 72 hours and 7 days after application
- Number of animals:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Other effects:
- Slight reactional dryness together with decrease in skin suppleness were also observed. Clear irritative phenomena were observed. They remained during 24 hours without any changes, and then decreased regularly. On day 6, not any irritation was seen, but slight changes in skin structure persisted until day 10.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for skin irritation.
- Executive summary:
Under the conditions of the present OECD 404 study, a single application of the test item to rabbits produced irritant effects, which were fully reversible within 6 days in all animals. Neither mortalities nor significant clinical signs of toxicity were observed. According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for skin irritation.
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
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The source study was conducted with isooctadecanoic acid. The read across source substance is considered a structural analogue taking into account the physico-chemical properties (surface active properties, logKow, water solubility) and the chemical structure of the test item (potassium soap of isooctadecanoic acid). Besides published data on eye irritation properties of long chain fatty acids and their salts are considered relevant for this read across approach. The results of the source substance are considered relevant for human health endpoints skin irritation, eye irritation and consecutive risk assessment of local effects. See read across document for further details.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Name of test material (as cited in study report): Prisorine 3505 Acide Isostearique
Physical state: liquid
Analytical purity: no data
Storage condition of test material: at room temperature
Other: light yellow - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test animals
Source: Elevage des Feuilletas
Weight at study initiation: 2 ± 0.2 kg
Housing: individually housed in stainless steel cages (61x46x34 cm) with a grid floor
Diet (ad libitum): UAR 112
Water (ad libitum): tap water
Acclimation period: 4 days
Environmental conditions
Temperature (°C): 22 ± 5
Humidity (%): 55 ± 25
Air changes (per hr): 14
Photoperiod (hrs dark / hrs light): 12 per day, in a complementary way with natural and artificial lighting - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- other: the untreated eye served as control
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 72 h. Reading time points: 1, 24, 48, 72 h
- Details on study design:
- Scoring system: Draize score
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal: #1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal: #1, 2, 3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24 h reading
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: at 24 h reading
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h reading
- Irritant / corrosive response data:
- A slight enanthema together with slight chemosis was observed in all 3 animals at the 1 hour reading. Enanthema remained during 48 hours in one animal and only 24 hours in the other two. Not any lesion of iris or cornea was recorded.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for eye irritation.
- Executive summary:
Under the conditions of the present OECD 405 study, a single application of the test item to rabbits produced slight irritant effects, which were fully reversible within 72 hours in all animals. Neither mortalities nor significant clinical signs of toxicity were observed. According to Annex I of Regulation (EC) 1272/2008, the test item has no obligatory labelling requirement for eye irritation.
Reference
The irritative phenomena were minor and not any lesion was seen after 48 hours.
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
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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