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EC number: 268-369-2 | CAS number: 68082-25-7 This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl carboxylic acid triethanol amine salt and SDA Reporting Number: 04-006-14.
- 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:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Fatty acids, C14-18 and C16-18 unsatd., compds. with triethanolamine
- EC Number:
- 268-369-2
- EC Name:
- Fatty acids, C14-18 and C16-18 unsatd., compds. with triethanolamine
- Cas Number:
- 68082-25-7
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, C14-18 and C16-18 unsatd., compds. with triethanolamine
- Test material form:
- liquid
1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- 7 days per week for a maximum period of 63 days, i.e. during 14 days of pre-mating and maximum 14 days of mating in both males and females. Then in females, treatment will be done during the gestation period and up to post-natal day 12. Males will be dosed after the mating period until the minimum total dosing period of 28 days is completed.
- Frequency of treatment:
- 7 days per week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Remarks:
- LD
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Remarks:
- MD
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- HD
- No. of animals per sex per dose:
- Group 1 (C, control): 0 mg/kg bw/day. 10 males and 10 females.
Group 2 (LD, low dose): 100 mg/kg bw/day. 10 males and 10 females.
Group 3 (MD, medium dose): 300 mg/kg bw/day. 10 males and 10 females.
Group 4 (HD, high dose): 1000 mg/kg bw/day. 10 males and 10 females. - Control animals:
- yes, concurrent no treatment
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, non-treatment-related
- Description (incidence and severity):
- In this study there were no clinical findings related to a systemic effect of the test item.
During the weekly detailed clinical observation, no significant changes or differences between the groups were found.
Female number 55 of the LD group was observed with the clinical findings of pale skin, hypothermia, half eyelid closure, moderate piloerection, and slow movements on post-natal day 0. However, these signs were not assumed to be test item-related but to be result of the abortion of pregnancy.
The finding of wound in two males of the HD group (male number 37: wound on snout, male number 40 wound on the head) were not considered to be test item-related. - Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- One female of the LD group (No. 55) was euthanized on post-natal day 0 due to animal welfare reasons
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The test item had no effect on body weight development in this study. Body weights of male and female animals were in the normal range of variation throughout the treatment period of this study.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- The test item had no effect on food consumption in this study. Mean daily food intake of male and female animals was in the normal range of variation throughout the treatment period of this study.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- The test item had no toxicologically relevant effect on haematology and blood coagulation parameters analysed at the end of the treatment period of this study.
Besides, all haematological parameters were within the normal range of historical data variation. Differences between the animals are due to the natural occurring inter-individual variation and are not assumed to be biologic ally relevant.
Blood coagulation was not affected by the test item as the individual values were within the normal range of variation for this strain. - Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- The test item had no toxicologically relevant effect on parameters of clinical biochemistry analysed at the end of the treatment period of this study.
All parameters of clinical chemistry were within the normal range of variation for this strain and without biological relevance. - Urinalysis findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The test item had no significant or toxicologically relevant effect on urinary parameters analysed at the end of the treatment period of this study.
One female of the MD group (number 24) showed an elevated level of erythrocytes in the urine. This was considered to be blood contamination during urine sampling and not related to treatment with the test item.
Further, one male of the LD group (number 59) was observed with a high level of ketones and one male of the MD group (number 68) showed a high level of protein in the urine. Both findings were considered to be incidental and not to be test item-related. - Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The test item had no toxicologically relevant effect on organ weights determined at the end of the treatment period of this study.
Mean pituitary weight was slightly higher in test item-treated males compared to the control group (deviation of LD from control: 13 %, deviation of MD from control: 38 %, deviation of HD from control: 27 %). Mean pituitary weight however, was slightly lower in females treated with TEA Trioleate compared to the corresponding control (deviation of LD from control: -17 %, deviation of MD from control: -24 %, deviation of HD from control: -16 %). As the effect on mean pituitary weight shows no dose-dependency and consistency between males and females, it is not assumed to be toxicologically relevant.
Mean thyroid/parathyroid weight was slightly higher in females of the MD group (deviation from control: 24 %) compared to the corresponding control group. However, this effect is not considered test item-related as mean thyroid/parathyroid weight was not affected in all other test item-treated groups.
Mean ovary weight was slightly lower in females of the HD group compared to the control group (deviation from control: 15 %). This difference is not assumed to be toxicologically relevant as female reproductive organs undergo variable inter-individual changes depending on the stage of the estrous cycle.
Slightly higher mean thymus weight of males of the HD group (deviation from control: 14 %) and slightly higher mean thymus weight of females of the LD group (deviation from control: 16 %) were considered as incidental and not related to treatment with the test item as this effect does not follow a dose-dependency and consistency when compared with respective control groups of males and females. - Gross pathological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- No specific gross pathological changes were recorded for male and female animals, except for a few females which were not considered to be treatment-related.
Single findings like kidney cyst (MD male number 24), a mass in the abdominal cavity (MD female number 25), a red spotted thymus (LD female number 58), an abnormally colored pancreas (red; HD female number 73), and an abnormally colored pancreas (red) and an abnormally shaped papillary process of the liver (MD female number 68) were incidental and are not assumed to be related to treatment with the test item.
Female number 55 which was euthanized on post-natal day 0 with clinical signs of abortion was observed with an abnormal content (dark) in stomach, duodenum, jejunum, ileum, and cecum. Further, the uterus was found containing a placenta indicating the birth process of this animal. However, the findings observed in this single female were not considered to be test item-related. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no effects treatment-related observed
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- No treatment related effects were observed up the maximum dose tested. NOAEL >= 1000 mg/kg bw/day
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