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EC number: 268-329-4 | CAS number: 68052-51-7
- 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
- Study period:
- August - October 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Tributylethylammonium ethyl sulphate
- EC Number:
- 268-329-4
- EC Name:
- Tributylethylammonium ethyl sulphate
- Cas Number:
- 68052-51-7
- Molecular formula:
- C14H32N . C2H5O4S (or C16H37NO4S)
- IUPAC Name:
- tributyl(ethyl)azanium ethyl sulfate
- Details on test material:
- - Name of test material (as cited in study report): TBEAES
- Substance type: organic
- Physical state: Paste
- Storage condition of test material: At room temperature in the dark
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Deutschland, Kisslegg, Germany.
- Age at study initiation: at least 6 weeks old.
- Weight at study initiation: 1435-1524 grams.
- Housing: Animals were housed individually in cages with perforated floors.
- Diet: Free access to pelleted diet for rabbits (Charles River Breeding and Maintenance DIet for Rabbits, Altromin, Germany). Hay was abailable during the study period.
- Water: Free access to tap water.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
set to maintain:
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): approx 15
- Photoperiod (hrs dark / hrs light): 12/12
Deviations from these optimal conditions were noted, but were considered not to have affected study integrity.
IN-LIFE DATES: From: 1 to 4 August 2000
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Adjacent areas of the untreated skin of each animal served as controls.
- Amount / concentration applied:
- 0.5 grams of test substance.
- Duration of treatment / exposure:
- Single four hour application .
- Observation period:
- 72 hours.
- Number of animals:
- 3 males.
- Details on study design:
- TEST SUBSTANCE PREPARATION
The test substance was heated up to 70°C to facilitate handling. The test substance was allowed to cool down to an estimated temperature of 40°C and dosed undiluted.
TEST SITE
Approximately 24 hours before treatment, the dorsal fur was clipped with electric clippers, exposing an area of approximately 150 square centimeters (10x15 cm). To facilitate scoring, treated skin areas were re-clipped at least 3 hours before the observations.
The test substance was applied to the skin of one flank, using a patch of 2x3 cm.
REMOVAL OF TEST SUBSTANCE
Four hours after the application, the dressing was removed and the skin cleaned of residual test substance using tap water.
OBSERVATIONS
- Mortality/Viability: Twice daily.
- Toxicity: At least once daily.
- Body Weight: Day of treatment (prior to application).
- Necropsy: No histopathlogy was performed, since the skin reactions were not masked by test substance staining
- Irritation:
The skin reactions were assessed at approximately 1, 24, 48 and 72 hours after the removal of the dressings and test substance. The irritation scores and a description of all other (local) effects were recorded.
SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: animal #1 and #2
- Time point:
- other: 1 hour
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: animal #1 and #2
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: animal #3
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mean
- Irritant / corrosive response data:
- Exposure resulted in very slight to well-defined erythema in the treated skin-areas of the three rabbits. The skin irritation had resolved within 24 hours after exposure in all animals
There was no evidence of a corrosive effect on the skin. - Other effects:
- No staining of the treated skin by the test substance was observed. No moratlity occured and no symptoms of systemic toxicity were observed in the animals during the test period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In an skin irritation study with rabbits, performed according to OECD/EC test guidelines, slight to well-defined erythema was observed, which was fully reversible within 24 h. No oedem was observed. TBEAES does not have to be classified for skin irritation.
- Executive summary:
Assessment of primary skin irrition/corrosin was performed with TBEAES in the rabbit using a 4 hour semi-occlusive application according to OECD/EC guidelines and GLP principles. There was no evidence of a corrosive effect on the skin. Exposure to TBEAES resulted in very slight to well-defined erythema in the treated skin-areas of the rabbits, which had resolved within 24 hours. No oedema was observed. No mortality or symptoms of systemic toxicity were observed. Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC), TBEAES does not have to be classified and has no obligatory labelling requirement for skin irritation.
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