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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
In a OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) by oral route, no treatment related effects were observed up the maximum dose tested. NOAEL >= 1000 mg/kg bw/day.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on mating procedure:
- Mating will be performed using a ratio of 1:1 (male to female) (if possible). The vaginal smear of the females will be checked every morning after the start of the mating period to confirm the mating. If the vaginal smear of a particular female is not found to be sperm-positive, the actual stage of the estrus cycle on that day will be documented. The day of the vaginal plug and/or sperm will be considered as day 0 of gestation.
The cages will be arranged in such a way that possible effects due to cage placement are minimised. In case of unsuccessful mating, re-mating of females with proven males of the same group can be considered. - 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
- 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
- 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. - Dermal irritation (if dermal study):
- not examined
- 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
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
- 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
- Critical effects observed:
- no
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- not examined
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not examined
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
- Reproductive function: oestrous cycle:
- not examined
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- not examined
- Remarks on result:
- not measured/tested
- Critical effects observed:
- no
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not examined
- Other effects:
- not specified
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Dose descriptor:
- NOAEL
- Generation:
- F1
- 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
- Critical effects observed:
- no
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Other effects:
- not examined
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Remarks on result:
- not measured/tested
- Critical effects observed:
- no
- Reproductive effects observed:
- no
- Conclusions:
- No treatment related effects were observed up the maximum dose tested. NOAEL >= 1000 mg/kg bw/day
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- guideline study.Klimish score: 1
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
Not examined
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the results of the Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD 422), no treatment related effects were observed up the maximum dose tested. Therefore no classification according to Regulation (EC) n. 1272/2008 is deemed.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.