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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin 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
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 431-540-9
- EC Name:
- -
- Cas Number:
- 170573-32-7
- Molecular formula:
- C21H43NO2
- IUPAC Name:
- N-(2-hydroxypropyl)-2,2,5,8,11,11-hexamethyldodecanamide
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- Batch no.: DM5/282
Appearance: amber cloudy liquid
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source: "l'elevage Cunicole de Val de Seile, 80160 Prouzel, France"
Acclimation: at least 5 days
Weight: 2.4 +/- 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
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Remarks:
- 6 cm2
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- At 1, 24, 48 and 72h and daily thereafter (for 9 days)
- Number of animals:
- 3 (males)
- Details on study design:
- Skin reactions (erythema and oedema) were evaluated using the Draize scoring (and every other symptoms was recorded as well).
They were measured after 24, 48 and 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Important skin reactions were observed during at least 48 hours in the 3 rabbits. They worsened for 3 days thereafter (until Day 5) with the development of an erythema. No oedema was observed. From Day 5, the erythema decreased and disappeared on Day 8. The skin remained dry until Day 8. As 2 animals out of 3 presented an erythema of 2.0 and the reactions were reversible within 8 days, the test substance was not considered irritant to rabbit skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance was not considered to be irritant to rabbit skin.
- Executive summary:
A study was conducted to determine the skin irritation / corrosion potential of the test substance 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. The skin reactions were present until Day 5 with the development of erythema. No oedema was observed. From Day 5, the erythema decreased and disappeared on Day 8. The skin remained dry until Day 8. Under the study conditions, the test substance was not considered to be irritating to rabbit skin (Clouzeau, 1992).
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