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EC number: 271-843-1 | CAS number: 68609-93-8
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- From September 19, 2016 to February 17, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 408
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.26
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EPA OPPTS 870.3100
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 9-Octadecenoic acid (Z)-, sulfonated, potassium salts
- EC Number:
- 271-843-1
- EC Name:
- 9-Octadecenoic acid (Z)-, sulfonated, potassium salts
- Cas Number:
- 68609-93-8
- Molecular formula:
- A generic formula cannot be provided for this UVCB substance. The alkyl chain length of the sulfonated fatty acids range from C12-C22, however the major alkyl chain is C18.
- IUPAC Name:
- 9-Octadecenoic acid (Z)-, sulfonated, potassium salts
- Test material form:
- solid
- Details on test material:
Purity/Composition: UVCB (100%);
Appearance: orange-brown crystalline powder with lumps.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- SPF-bred Wistar Han rats
- Details on species / strain selection:
- Rationale: Recognized by international guidelines as the recommended test system (e.g. EPA, FDA, OECD and EC).
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test system Rat: Crl:WI(Han) (outbred, SPF-Quality).
Source: Charles River Deutschland, Sulzfeld, Germany.
Total number of animals: 40 males, 40 females (females were nulliparous and nonpregnant).
Age at start of treatment: Approximately 6 weeks.
Identification: Earmark and tattoo.
Randomization: By computer-generated random algorithm according to body weight, with all animals within ± 20% of the sex mean.
Acclimatization period: At least 5 days before the start of treatment under laboratory conditions.
Health inspection: Upon receipt of the animals.
Conditions: Environmental controls for the animal room were a mean daily temperature range of 21 to 22°C, a mean daily relative humidity range of 44 to 63%, at least 10 air changes/hour, and a 12-hour light/12-hour dark cycle. The light/dark cycle was interrupted for study related activities.
Accommodation: Group housing of 5 animals per sex in Macrolon cages (MIV type, height 18 cm) with sterilized sawdust as bedding material (Lignocel S 8-15, JRS - J.Rettenmaier & Söhne GmbH + CO. KG) and paper as cage-enrichment (Enviro-dri, Wm. Lilico & Son (Wonham Mill Ltd)). During locomotor activity monitoring, animals were housed individually in a Hi-temp polycarbonate cage (Ancare corp).
Diet: Free access to pelleted rodent diet (SM R/M-Z from SSNIFF Spezialdiäten). During motor activity measurements, animals did not have access to food for a maximum of 1 hour and 43 minutes. Water: Free access to tap water. During motor activity measurements, animals did not have access to water for a maximum of 1 hour and 43 minutes.
Diet, water, bedding and cage enrichment evaluation for contaminants and/or nutrients was performed according to facility standard procedures. There were no findings that could interfere with the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- Method: Oral gavage, using a plastic feeding tube. Formulations were placed on a magnetic stirrer during dosing. A dose control system (DCS) was used as additional check to verify the dosing procedure according to Standard Operating Procedures.
Dose volume: 5 mL/kg body weight. Actual dose volumes were calculated weekly according to the latest body weight.
Frequency: Once daily, 7 days per week, approximately the same time each day with a maximum of 6 hours difference between the earliest and latest dose. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Sampling: Samples (0.5 mL) were taken using a pipette, and were weighed on an analytical balance at 4 decimals precision. During sampling, formulations were placed on a magnetic stirrer. Immediately after sampling (accuracy and homogeneity samples) or after 5 hours at room temperature under normal laboratory light conditions (stability samples), samples were stored on dry ice until receipt.
Analysis: Samples of formulations were analyzed for homogeneity (highest and lowest concentration) and accuracy of preparation (all concentrations). Stability in vehicle over 5 hours at room temperature under normal laboratory light conditions was also determined (highest and lowest concentration). The accuracy of preparation was considered acceptable if the mean measured concentrations were 90-110% of the target concentration. Homogeneity was demonstrated if the coefficient of variation was ≤ 10%. Formulations were considered stable if the relative difference before and after storage was maximally 10%. - Duration of treatment / exposure:
- 90 d
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10 males and 10 females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Estrous cycle determination: All females had a daily lavage from Day 70 up to and including Day 90 to determine the stage of estrous (according to Standard Operating Procedures).
Examinations
- Parental animals: Observations and examinations:
- The following parameters were evaluated: clinical signs daily; functional observation tests in Week 13; body weight and food consumption weekly; ophthalmoscopy at pretest and in Week 13; clinical pathology and macroscopy at termination; organ weights and histopathology on a selection of tissues.
- Oestrous cyclicity (parental animals):
- Estrous cycle determination All females had a daily lavage from Day 70 up to and including Day 90 to determine the stage of estrous (according to Standard Operating Procedures).
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- In the surviving animals, diarrhoea was observed on single occasions in seven 1000 mg/kg animals towards the end of the treatment period. Swelling/gas distention of the abdomen was observed in three 1000 mg/kg and two 300 mg/kg animals, each for single short and transient bouts. Rales were also observed for single short and transient bouts in five 1000 mg/kg animals and two 100 mg/kg animals. No findings were noted during the arena observations in this study.
A dose-related increase in salivation seen after dosing among treated groups was not considered toxicologically relevant, taking into account the nature and minor severity of the effect and its time of occurrence (i.e. after dosing). This sign was considered to be a physiological response related to taste of the test substance rather than a sign of systemic toxicity.
Any other clinical signs noted during the treatment period occurred within the range of background findings. - Mortality:
- mortality observed, treatment-related
- Description (incidence):
- There were two death males treated at 1000 mg/kg.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Slight (not statistically significant) trends towards a lower body weight and body weight gain were seen in 1000 mg/kg treated animals during a large proportion of the study.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- A statistically significant increase in the incidence of focal corneal edema was observed in 100 mg/kg females at Week 13, however this finding was not considered treatment-related as it occurred in a non-dose related manner.
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The following (statistically significant) changes in haematology parameters distinguished treated from control animals:
- White blood cell count was increased in 1000 mg/kg females, lymphocyte levels were reduced in 1000 mg/kg males and 1000 mg/kg females, and neutrophil levels were increased in 300 mg/kg males and 1000 mg/kg males and females (males not statistically significant).
- Red blood cell distribution width (%RDW) was increased in 1000 mg/kg females, and haemoglobin levels, mean red blood cell volume (MCV), and mean cell haemoglobin concentration (MCH) were reduced in 1000 mg/kg males and females.
Any other statistically significant changes in haematology parameters were considered to be unrelated to treatment as these occurred in the absence of a dose-related trend. - Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- The following (statistically significant) changes in clinical biochemistry parameters distinguished treated from control animals:
- Alanine aminotransferase (ALAT) levels were significantly increased in both male and female 1000 mg/kg animals, and aspartate transaminase (ASAT) levels were increased in 1000 mg/kg females.
- Total protein and albumin levels were increased in 1000 mg/kg, and 100/300/1000 mg/kg males, respectively. Total bilirubin levels were increased in 100, 300 and 1000 mg/kg males.
- Urea levels were increased in 1000 mg/kg males and females, and creatinine levels were increased in 100 and 1000 mg/kg males and 1000 mg/kg females.
- Glucose and cholesterol levels both reduced in 1000 mg/kg males and females.
- Inorganic phosphate levels were increased in 1000 mg/kg males and females. Sodium levels were increased in 100 and 300 mg/kg males and females, however these findings occurred in the absence of a dose-related trend and therefore considered not toxicologically relevant.
Any other statistically significant changes in clinical biochemistry parameters were considered to be unrelated to treatment as these occurred in the absence of a dose-related trend. - Urinalysis findings:
- not examined
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- Foregrip strength was reduced in 300 and 1000 mg/kg males and 1000 mg/kg females in a statistically significant manner. And a slight (not statistically significant) reduction in total movement and ambulatory behavior was observed in 1000 mg/kg females.
Further observations, hearing ability, pupillary reflex, static righting reflex and hindgrip strenght were normal in all examined animals. Motor activity was similar between treated and control males. And all groups showed a similar motor activity habituation profile with a decreasing trend in activity over the duration of the test period. - Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Test substance-related microscopic findings were noted, starting at 300 mg/kg in the kidneys and mesenteric lymph nodes of males and females, and at 1000 mg/kg in the adrenal glands of males and females, the pancreas of males, and the spleen of females.
Kidney findings included an increased incidence and severity of tubular vacuolation, with pigmented material in the cortex, which was present in males and females starting at a dose of 300 mg/kg. Tubular degeneration and an increased severity and/or incidence in tubular basophilia was observed at 1000 mg/kg.
In the mesenteric lymph node, an increased incidence and severity of macrophage foci was recorded, starting at 300 mg/kg in both sexes.
In the adrenal gland, vacuolation of the zona glomerulosa was recorded at an increased incidence and/or severity in both sexes at 1000 mg/kg.
In the pancreas, increased apoptosis of acinar cells was recorded in males treated at 1000 mg/kg. One female at 1000 mg/kg with minimal increased apoptosis was considered to be within background levels.
In the spleen, increased incidence and severity of extramedullary hematopoiesis and increased severity of pigmentation was recorded in females treated at 1000 mg/kg.
The remaining histological changes were considered to be incidental findings or within the range of background pathology encountered in rats of this age and strain. There were no test substance-related alteration in the prevalence, severity, or histological character of those incidental tissue alterations. - Histopathological findings: neoplastic:
- not examined
- Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Increased macrophages in male and female mesenteric lymph nodes starting at 300 mg/kg/day, vacuolation of the zona glomerulosa of male and female adrenal glands at1000 mg/kg/day and increased apoptosis in male pancreas at 1000 mg/kg/day were also considered to be non-adverse since these findings were slight in nature.
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No treatment related changes in estrous cycle length were noted across the dose groups during the period in which estrous cycle length was determined (Day 77 up to and including Day 98).
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- not examined
Details on results (P0)
Effect levels (P0)
- 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: estrous cycle regularity, spermatogenesis staging and morphology of gonads and accessory reproductive organs
Results: P1 (second parental generation)
Effect levels (P1)
- Key result
- Remarks on result:
- not measured/tested
Results: F1 generation
Effect levels (F1)
- Key result
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
- Treatment related:
- no
Applicant's summary and conclusion
- Conclusions:
- Under the study conditions, no toxicologically significant changes were noted in any of the reproductive parameters assessed in this study (estrous cycle regularity, spermatogenesis staging and morphology of gonads and accessory reproductive organs) revealed no treatment-related changes.
- Executive summary:
A study was conducted to determine repeated dose toxicity of the test substance when administered to rats according to OECD Guideline 408, EU Method B.26 and EPA OPPTS 870.3100. The test substance, formulated in water, was administered daily for at least 90 d by oral gavage to SPF-bred Wistar Han rats. One control group and three treated groups were tested, each consisting of 10 males and 10 females, at the dose levels of 0, 100, 300 and 1000 mg/kg bw/d. Formulation analyses confirmed that formulations of test substance in water were prepared accurately and homogenously. Under the study conditions, no toxicologically significant changes were noted in any of the reproductive parameters assessed in this study (estrous cycle regularity, spermatogenesis staging and morphology of gonads and accessory reproductive organs) revealed no treatment-related changes (Beerens-Heijnen, 2017).
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