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EC number: 273-601-0 | CAS number: 68990-47-6
- 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
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 04 - June 25 2010
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Qualifier:
- according to guideline
- Guideline:
- other: Combined repeated dose Toxicity study with the Reproduction/ developmental Toxicity screening Test. EPA 712-C-00-368, July 2000.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine
- EC Number:
- 273-601-0
- EC Name:
- Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine
- Cas Number:
- 68990-47-6
- Molecular formula:
- The substance is a UVCB substance. One of the most likely and the smallest molecule arising from the reaction process is assumed to be: C18H33O. C18H31O. 2C4H12N3 . C4H2O2
- IUPAC Name:
- Reaction product of 2,5-Furandione with reaction products of tall-oil fatty acids, diethylenetriamine, triethylenetetramine and tetraethylenepentamine
- Details on test material:
- Name: Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine
CAS No.: 68990-47-6
Batch no.: TEE3316/22
Expiry Date: November 2011
Physical state at RT: solid
Colour: dark
Purity: Date of analysis 11 February 2010 97% (w/w)
Storage Conditions: at room temperature, protected from light
Solubility in Water: very low
Safety Precautions: Standard Safety procedures were sufficient to assure personnel health and safety.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
Name: Corn oil
Justification for use and choice of vehicle (if other than water):The vehicle was chosen as suggested by sponsor and the test item‟s solubility.
Batch No.: 11KBC6753
Storage conditions: at room temperature (RT),
Safety precautions: Routine hygienic procedures were sufficient to assure personnel health and safety - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- The animals will be dosed with the test item on 7 days per week for a period of approximately 54 days. The test substance will be administered daily during 14 days pre mating and 14 days mating in both male and in female, during gestation period and up to post natal day 3 in females. Males will be dosed after the mating period until the minimum total dosing period of 28 days has been completed.
- Frequency of treatment:
- daily; The animals were dosed with the test item on 7 days per week basis.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
300 mg/kg bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
600 mg/kg bw
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 80 animals (10 non pregnant nulliparous females and 10 adult males /group) were included in the study.
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Animals were examined for the daily clinical signs, mortality, weekly detailed clinical observations, pre treatment and at termination for functional observations. Body weight and food consumption was measured weekly except food consumption was not measured during the mating period (female) and mating/post mating period (male). Haematological and clinical biochemistry evaluations were performed on blood samples collected at terminal sacrifice from five males and five randomly selected females from each group. Urinalysis was performed on samples collected at terminal sacrifice from five randomly selected males from each group.
- Sacrifice and pathology:
- Males and females were sacrificed on treatment day 29-30, post natal day 4 respectively and subjected to necropsy. Non Pregnant females were sacrificed on their respective day 26 after the evidence of mating.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- due to gavaging error
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- due to gavaging error
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks on result:
- not determinable
- Remarks:
- no NOAEL identified
- Dose descriptor:
- LOAEL
- Effect level:
- <= 300 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Based on the limited histopathological evaluation of the two decedents treated at 600 mg/kg/day, no cause of death could be determined for female animal No. 23. Histopathological lung findings in male No. 61 (intraalveolar eosinophilic material, perivascular edema/hemorrhage and diffuse congestion) suggest gavaging error as its cause of death.
Reproductive organs:
In the female and male reproductive organs, no histopathological lesions considered to be test item-related were noted. Histologically, female reproductive organs showed physiological postpartum morphology in most surviving animals. The number of large corpora lutea in the ovaries was essentially similar in all study groups. Based on clinical observations, each one female treated at 0, 300 or 600 mg/kg/day was found not to be pregnant at terminal sacrifice, and reproductive organ histomorphology of these animals indicate normal sexual cycling activity.
In the male reproductive organs, a minimal number of unilateral atrophic tubules in the testis were seen in one male treated at 600 mg/kg/day without dose relationship and were considered to be incidental. In the epididymis, spermatic granuloma was observed in a small number of treated males and in one control, corroborating the macroscopic finding of spots on the epididymis, and was considered a spontaneous lesion. There were also incidental infiltrates with inflammatory cells in the prostate gland.
Other organs:
In the other organs evaluated in this study, test item-related histopathological changes were seen in the lung. Multifocal subacute bronchopneumonia, characterized by peribronchial foci of prominent fibrosis, with re-epithelialization, infiltration with mononuclear cells, histiocytes and occasional multinucleated cells, was observed in a small proportion of treated males and females of all dose groups, without dose relationship. In some animals the lesions contained also foci of necrosis, and in some animals the pulmonary changes were less well organized and contained larger numbers of mixed cells. The mechanism of this lesion is not clear.
A mild amount of intrahistiocytic black material was seen in the lung of each one male treated at 300 or 1000 mg/kg/day.
All other histopathological changes seen in this study were considered to be incidental in origin and/or within the range of expected changes for rats of this age and strain kept under laboratory conditions.
Applicant's summary and conclusion
- Conclusions:
- Test item-related histopathological changes were restricted to the lung. Multifocal subacute bronchopneumonia, characterized by peribronchial foci of prominent fibrosis, with re-epithelialization, infiltration with mononuclear cells, histiocytes and occasional multinucleated cells, was observed in a small proportion of treated males and females of all dose groups, without dose relationship. In addition, a mild amount of intrahistiocytic black material was seen in the lung of each one male treated at 300 or 1000 mg/kg/day.
As a conclusion, based on the pathological evaluation, a No-Observed-Effect-Level (NOEL) could not be determined in this study. - Executive summary:
Macroscopic observations recorded at necropsy and histological slides were evaluated from male and female Wistar rats of a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with daily oral administration by gavage of Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine (test item) at dose levels of 0 (vehicle control), 300, 600 or 1000 mg/kg/day. The dosing period was daily during 14 days pre-mating, during the mating period, then during the gestation period and up to post-natal day 3 in females. Dosing of the males was continued after the mating period until completion of a minimum total dosing period of 28 days. Two rats treated at 600 mg/kg/day were found dead during the early treatment period. Based on the limited pathological evaluation of these decedents, no cause of death could be determined for the female, and gavaging error was considered to be the probable cause of death for the male. In the female and male reproductive organs, no histopathological lesions considered to be test item-related were noted. Based on clinical observations, three females had been recorded not to be pregnant during the study and showed normal sexual cycling activity in histopathology. Test item-related histopathological changes were restricted to the lung. Multifocal subacute bronchopneumonia, characterized by peribronchial foci of prominent fibrosis, with reepithelialization, infiltration with mononuclear cells, histiocytes and occasional multinucleated cells, was observed in a small proportion of treated males and females of all dose groups, without dose relationship. In addition, a mild amount of intrahistiocytic black material was seen in the lung of each one male treated at 300 or 1000 mg/kg/day. As a conclusion, based on the pathological evaluation, a No-Observed-Effect-Level (NOEL) could not be determined in this study.
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