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EC number: 241-924-6 | CAS number: 18016-43-8
- 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
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Additional information
The toxic effects on rats after repeated dosing with Oleic acid, compound with N-(2-aminoethyl)ethane-1,2-diamine, as well as any effects of the test item on male and female reproductive performance, such as gonadal function, conception, parturition and early lactation of the offspring were investigated in a study according to OECD guideline 422 and GLP (RTC, 2013). The rats were dosed at dose levels of 0, 80, 250 and 800 mg/kg bw/day.
The vehicle was corn oil. All doses were administered at a constant volume of 4 mL/kg body weight.
Males were treated for 2 weeks prior to pairing and during pairing with females until the day before necropsy, for a total of 34 days.
Females were treated for 2 weeks prior to pairing, during pairing and throughout the gestation and lactation periods until Day 3post partum.
The following investigations were performed in all groups: body weight, clinical signs (including neurotoxicity assessment, motor activity and sensory reaction to stimuli), food consumption, oestrous cycle, mating performance, clinical pathology investigations (haematology and clinical chemistry), litter data, macroscopic observations, organ weights and histopathological examination.
Clinical signs and macroscopic observations of pups were also performed.
The histopathological examination was performed only on control and high dose groups (five animals/sex/group randomly selected). The identification of the stages of the spermatogenic cycle was performed in all males of the control and high dose groups.
In addition, coagulating glands, epididymides, preputial gland, prostate gland, seminal vesicles and testes were examined histopathologically on all parental males and cervix, clitoral gland, ovaries, uterus and vagina were examined histopathologically on all parental females.
Since histopathological changes were observed in control and high dose males, the examination was then extended to the thymus of the remaining males of the control and high dose groups and in all males of Groups 2 and 3.
Mortality and fate of females
There were no compound-related effects.
One male receiving 800 mg/kg bw/day was found dead on Day 6 of the study. The cause of death of this animal is suggested to be related to complications associated with mis-dosing.
All females proved to be pregnant except one control and one receiving 800 mg/kg bw/day.
The number of females with live pups on Day 4 post partum was 9 in the control, 10 in the low dose (80 mg/kg bw/day), 10 in the mid-dose (250 mg/kg bw/day) and 9 in the high dose group (800 mg/kg bw/day).
Clinical signsand clinical observations (Functional Observation Battery Tests)
Salivation was the main
clinical sign observed during the study in males at the dose levels
≥ 250 mg/kg bw/day and in females at 800 mg/kg bw/day.
Moreover the same males and females of the high dose group also showed hair loss.
Neurotoxicity assessment (removal of animals from the home cage and open arena)
Observation of animals at removal from the cage and in an open arena (neurotoxicity assessment) did not reveal changes attributable to the test item.
Body weight and body weight gain
No differences of toxicological significance in body weights were recorded in animals of both sexes compared to the control group, throughout the study.
Food consumption
No effects on food consumption were observed in either males or females.
Motor activity and sensory reactivity to stimuli
No relevant differences were noted in all parameters investigated between control and treated groups.
Haematology
No changes of toxicological relevance were found in either sex at any dose.
No toxicological changes were recorded in the coagulation test.
Clinical chemistry
No adverse findings were observed by clinical chemistry examination.
Oestrous cycle, reproductive parameters, pairing combination and mating performance
Oestrous cycle, pre-coital intervals, copulatory index and fertility index did not show intergroup differences.
Implantation, pre-implantation loss data, pre-birth loss data and gestation length of females
No relevant differences were observed for these parameters between treated groups and controls.
All dams, with the exception of two not pregnant females, gave birth between Days 22 and 23 post coitum.
Litter data at birth, on Day 1 and on Day 4 post partum of females and sex ratio of pups
Litter data and sex ratio were unaffected by treatment, at birth, on Day 1 and Day 4 post partum.
Clinical signs of pups
There were no compound-related effects.
Pre-weaning clinical signs were comparable between treated and control groups.
Necropsy findings in decedent pups and in pups sacrificed on Day 4 post partum
Necropsy findings in decedent pups and in pups sacrificed on Day 4 post partumdid not reveal any treatment-related effect.
Terminal body weight and organ weights
Terminal body weight was unaffected by treatment in both sexes.
Absolute and relative organ weights were, in general, comparable between treated and control groups.
Macroscopic observations
There were no compound-related effects.
Microscopic observations
No treatment-related changes were noted. In addition, seminiferous tubules were evaluated with respect to their stage in the spermatogenic cycle and no alterations were noted.
Conclusions
On the basis of the results obtained in this study the NOAEL (No Observed Adverse Effect Level) for general toxicity and for reproductive and developmental toxicity was considered to be 800 mg/kg bw/day for males and females.
Based on the occurrence of salivation, which might be a local reaction to irritancy or taste of the test compound, the NOEL (No Observed Effect Level) was considered to be 80 mg/kg bw/day.
Short description of key information:
NOAEL systemic, reproduction and development = 800 mg/kg bw/day (OECD 422, RTC 2013)
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
Justification for classification or non-classification
Based on the available data, the test substance is not classified with regard to toxicity to reproduction according to Directive 67/548/EEC (DSD) and Regulation (EC) No 1272/2008 (CLP), respectively.
Additional information
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