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EC number: 800-182-9 | CAS number: 1426148-68-6
- 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
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted and documented dose-range-finder study which was performed following OECD guideline 407 testing principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- Dose-range-finder with limited parameters investigated
- Principles of method if other than guideline:
- Screening study for establishing dose levels for subsequent studies and for comparing general toxicity profiles of ethoxylated alcohols
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Alcohols, C6-C8-(even numbered, linear)-ethoxylated (<2,5 EO)
- EC Number:
- 800-182-9
- Cas Number:
- 1426148-68-6
- Molecular formula:
- R-O-R' , whereas R=C6-8-(even numbered, linear, saturated)-alkyl and R'=H or xEO wheras x=1-12, mean=2,3
- IUPAC Name:
- Alcohols, C6-C8-(even numbered, linear)-ethoxylated (<2,5 EO)
- Test material form:
- other: liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 238 - 258 (males), 155 - 173 (females)
- Fasting period before study: overnight
- Housing: individually in IVC cages, type III H
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): min 10 per hour
- Photoperiod (hrs dark / hrs light): 12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Test item was prepared freshly on each administration day before the administration
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 62,5. 250, 1000 mg/kg
Basis:
actual ingested
- No. of animals per sex per dose:
- 3 male and 3 female animals per group
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations were included.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes
- Time schedule for examinations: days 1, 7 and 14
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at terminal sacrifice
- Anaesthetic used for blood collection: No
- Animals fasted: Yes, overnight
- How many animals: all animals
- Parameters examined: haematocrit, haemoglobin content, red blood cell count, platelet count, white blood cells
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at terminal sacrifice
- Animals fasted: Yes, overnight
- How many animals: all animals
- Parameters examined: ALAT, ASAT, AP, creatinine, total protein, albumin, urea, total cholesterol, Na, K
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
OTHER: Inflammatory markers (C-reactive protein, alpha-1-AGP, haptoglobin) - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: No
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- slight body weight decrease in high dose animals
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- decrease in WBC in high dose males
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- ASAT and ALAT slightly increased in Md and HD animals, alkaline phosphatase decreased in MD and HD animals, creatinine decreased in female HD animals
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Repeated administration via gavage of the submission substance for 14 consecutive days to rats revealed no mortalities but minor toxicological findings in animals of the 250 mg/kg and 1000 mg/kg dose groups.
- Executive summary:
The submission substance was orally administered in graduated doses of 0, 62.5, 250 and 1000 mg/kg body weight per day to 3 groups of 3 male and 3 female Wistar rats each by oral gavage. One group receiving the vehicle sterile water served as control. The volume of application was 5 mL/kg body weight and the animals were dosed 7 days per week for a period of 14 days. All surviving animals were sacrificed on day 15 and were subjected to a detailed gross necropsy. All found dead animals, moribund and intercurrently sacrificed animals were also subjected to a gross necropsy. Body weight gain and food consumption were measured. Organ weights were taken from all terminally sacrificed animals.
Test item related clinical signs (i.e. piloerection, salivation, respiratory sound, moving the bedding) were observed in all high dose male and female animals. One female animal from the high dose group was found dead on day 2. The cause of the death could not be determined. Clinical signs of intoxication were not revealed throughout the study. Body weights were slightly decreased in both, male and female animals of the mid and high dose group. This corresponded with a slight decrease in food consumption in the mid and high dose animals. All group mean and individual values of haematological parameters were within the biological range except for an decrease in WBC. Clinical chemistry changes especially in high dose animals were mainly related to slight increases in ALAT and ASAT activities as well as decreases in alkaline phosphatase and creatinine. Gross pathology revealed no macroscopic findings in any of the treatment or control groups. With regard to organ weights, no treatment related effects occurred. Based on the results, it was concluded that dose levels of 62.5, 250 and 1000 mg/kg body weight may be appropriate for any subsequent 28-day repeated dose toxicity and/or reproductive/developmental screening study.
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