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EC number: 268-793-8 | CAS number: 68140-41-0
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29th August 2017 to 5th September 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Oleic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)
- EC Number:
- 268-793-8
- EC Name:
- Oleic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)
- Cas Number:
- 68140-41-0
- Molecular formula:
- C18H34O2.C4H11NO
- IUPAC Name:
- oleic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Male New Zealand White Rabbits approximately ten to twelve weeks old were used for this study.
The rabbits were obtained from Kuiper Rabbitry, Gary, Indiana. The rabbits weighed from 2.88 to 3.20
kilograms at the start of the study and were individually housed in stainless steel cages in a
temperature (20 ± 3° C), humidity (30-70%), and (12 hour/cycle) light controlled room. Each rabbit was
assigned a test animal number which appeared as an ear tag and also appeared on a cage card visible
on the front of each cage. The rabbits were nulliparous and non-pregnant. The rabbits were
maintained according to the recommendations contained in the National Academy Press 2011: "Guide
for the Care and Use of Laboratory Animals". They were conditioned for at least five days prior to
study initiation. Purina Laboratory Rabbit Chow and water were available ad libitum. All animals used
for this study were considered to be in good health at study initiation.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.5ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- 3 animals
- Details on study design:
- The day before study initiation, electric clippers were used to remove the hair from the left side of the trunk, from the midline of the back to the abdomen. The following day a 0.5 ml aliquot of the test material was then applied to an area approximately 6 square centimeters on the side of the test animal. The application site is located approximately 5-7 centimeters down from the backbone. The test substance was then covered with a 2.5 cm² - 2 layer gauze patch held in place with non-irritating Kendall Curity Standard Porous Tape and the patch was then covered with a semi-occlusive plastic overwrap secured in place with Kendall Curity Standard Porous Tape for the duration of the exposure period. At the end of the 4 hour contact period, excess material was removed from the site; the site being observed and scored. Dermal irritation readings for erythema and edema were performed approximately 4.5, 24, 48, 72 and 168 hours after treatment.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.89
- Max. score:
- 2
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 1
- Reversibility:
- fully reversible within:
- Remarks:
- 7 days
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The application sites were graded for indication of skin reactions at 4.5, 24, 48, 72 and 168 hours after test substance application. There were minor skin irritation reactions in all of the test subjects. The maximum skin irritation score was 2 for erythema and 1 for oedema at the 72 hour observation. The mean value for erythema was 1.89 and oedema was 0.67 in the 3 animals from grading’s at 24, 48 and 72 hours after patch removal. Therefore, in accordance with the CLP guidance, the test substance does not meet the classification criteria for Skin irritation.
- Executive summary:
The study was conducted in accordance with the OECD guideline, 404, to determine its skin irritation potential by applying 0.5ml of the test on unabraded site, left side of the trunk from the midline of the back to the abdomen, of 3 albino rats. The excess material was removed from the site after 4 hours and the site was observed and scored. Dermal irritation readings for erythema and oedema were performed approximately 4.5, 24, 48, 72 and 168 hours after treatment. There were minor skin irritation reactions in all of the test subjects. The maximum skin irritation score was 2 for erythema and 1 for oedema at the 72 hour observation. The mean value for erythema was 1.89 and oedema was 0.67 in the 3 animals from grading’s at 24, 48 and 72 hours after patch removal. Therefore, in accordance with the CLP guidance, the test substance does not meet the classification criteria for Skin irritation.
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