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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3/01/2006-2/16-2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an internationally approved protocol and followed Good Laboratory Practice standards.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- Animals in the 12 and 50 mg/kg dose group were underdosed. This did not affect the outcome of the study since the highest dose level was properly administered and no adverse effects were observed. Other deviations did not affect the outcome either.
- GLP compliance:
- yes
- Limit test:
- no
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)
- Test material form:
- liquid: viscous
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: 8 weeks
- Weight at study initiation: 204-270 g (male); 151-207 (female)
- Housing: individually in wire mesh suspension cages
- Diet (e.g. ad libitum): ad libitum except prior to blood collection
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Test article formulations were prepared weekly as single formulations for each dosage level through Apr 7. For the remainder of the study, the 12 adn 50 mg/mL formulations were prepared every other day and the 200 mg/mL formulation continued to be prepared weekly. Formulations were divided into aliquots for daily dispensation and stored at room temperature with continuous stirring.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples (1mL) for concentration analysis were collected from each test group during the first week and last week. By extrapolation from the available information, Group 2 animals were under-dosed by up to 80% during the first two weeks and by up to 22.2% during the last two weeks. Group 3 animals were under-dosed by up to 50% during the first two weeks. The 1000 mg/kg/day group was dosed within acceptable ranges for the entire 28 days of dosing.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 60, 250, 1000 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 14/sex/dose in control and high dose; 7/sex/dose in the low and mid dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Following 4 weeks of dose administration, 7 rats/sex/group were euthanized; the remaining 7 rats/sex in the control and high dose groups were euthanized following a 14-day nondosing (recovery) period.
Examinations
- Observations and examinations performed and frequency:
- All animals were observed twice daily for mortality and moribundity. Clinical examinations were performed daily, and detailed physical examinations were performed weekly. Individual body weights and food consumption were recorded weekly. Functional observational battery and locomotor activity data were recorded for 7 animals/sex/group prior to the initiation of dose administration and during study week 3. Clinical pathology evaluations (hematology, serum chemistry and urinalysis) were performed for all rats assigned to the primary (study week 4) and recovery (study week 6) necropsies.
- Sacrifice and pathology:
- Complete necropsies were conducted on all animals, and selected organs were weighed. Selected tissues were examined microscopically from all animals in the control and 1000 mg/kg/day groups. Gross lesions were examined from all animals in the 60 and 250 mg/kg/day groups.
- Statistics:
- All statistical tests were performed using appropriate computing devices or programs.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- There was a low incidence of chronic and chronic active inflammation in the lungs that were considered due to accidental aspiration of dosing formulation and not a manifestation of systemic toxicity.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- > 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No signs of toxicity were observed in any of the parameters evaluated at any dose level tested.
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No signs of toxicity were observed in any of the parameters evaluated at any dose level tested.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study, EC 701-204-9 did not exhibit adverse toxic effects and the NOAEL >1000 mg/kg/day (the highest dose tested)
- Executive summary:
The registered substance was administered orally (gavage) to Crl:CD(SD) rats for 28 consecutive days at dose levels of 0, 60, 250, and 1000 mg/kg/day. All animals survived until scheduled necropsy. There were no test article related clinical findings or effects on body weight, food consumption, functional observational battery evaluations, locomotor activity, clinical pathology parameters or organ weights at any dose level. There were no test article related macroscopic or microscopic changes observed either. The No Observed Adverse Effect Level is greater than 1000 mg/kg/day.
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