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EC number: 701-204-9 | CAS number: -
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Remarks:
- study not completed
- Adequacy of study:
- supporting study
- Study period:
- 1996-04-15 to 1996-05-24
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Only the pilot phase of the Human Repeat Insult Patch Test was concluded due to observations suggestive of skin sensitization in a 14-Day Cumulative Irritation Study. Supporting evidence can still be obtained from the 31 one subjects that completed induction, rest and challenge in the pilot phase.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Repeated Insult Patch Test (Modified Draize Procedure)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)
- EC Number:
- 701-204-9
- Cas Number:
- 68784-17-8
- IUPAC Name:
- Reaction products of fatty acids, C14-C18 (branched and linear) and C18 (unsaturated) with tetraethylenepentamine (linear, branched, cyclic)
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 37 enrolled; 31 completed
- Sex: 27 female, 10 male
- Age: 21-60 years of age
- Race: not specified
- Demographic information: none specified - Clinical history:
- Subjects excluded from study for any of the following reasons:
-insulin dependent diabetes
-masectomy for cancer within the last year
-clinically significant skin disease
-previous participation in a patch study within last 4 weeks
-routine high dosage usage of anti-inflammatory drugs
-severe asthma
-immunological disorders
-use of topical drugs at patch site
-pregnant or lactating women
-known sensitivity to lubricant products
-daily exposure to lubricant products
-known allergy to detergents or sulfonates
-damaged skin at test site - Controls:
- Mineral Oil, U.S.P. applied as vehicle control with same study schedule
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: semiocclusive
- Description of patch: Webril pads secured on two opposing sides with hypoallergenic tape
- Vehicle / solvent: mineral oil
- Concentrations: 100%
- Volume applied: 0.2 ml directly to semi-occluded patches and applied to skin for 24 hrs/application
- Testing/scoring schedule: Induction applications made 3 times/wk for 3 consecutive weeks; 10-17 day rest period; Challenge application on sixth week to naive site
EXAMINATIONS
- Grading/Scoring system: modified Draize
Results and discussion
- Results of examinations:
- There were no adverse events observed or reported during the course of the study.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the study, no clinical irritation or evidence of contact sensitization was observed.
- Executive summary:
The objective of the study was to evaluate the potential for EC 701 -204 -9 to elicit dermal sensitization in human. This was accomplished via repetitive applications of test substance to the skin of human volunteers. Observations of irritation were reported and compared to vehicle control sites. Thirty one subjects (23 female, 8 male), between the ages of 21 and 60, completed the study. There were no adverse events observed or reported during the course of the study.
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