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EC number: 600-026-8 | CAS number: 1000817-22-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- testing lab.
- Limit test:
- no
Test material
- Reference substance name:
- Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide
- EC Number:
- 600-026-8
- Cas Number:
- 1000817-22-0
- Molecular formula:
- Unspecified
- IUPAC Name:
- Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide
- Details on test material:
- Name of test substance: Kerocom FM 38
Batch identification 2008250
Purity: 100% condensation product (BASF Project No. 08L00358)
Homogeneity: Homogeneous
Stability: The stability of the test substance under storage conditions over the test period was guaranteed by the sponsor, and the sponsor holds this responsibility.
Physical state/appearance: liquid/yellow to brown, clear
Storage conditions: ambient (room temperature)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Age (at supplied); sex: 32-34 days; males and females
Identification: The rats were identified clearly by ear tattoo.
The rats were housed together (5 animals per cage) in H-Temp polysulfonate cages supplied by TECNIPLAST, Hohenpeißenberg, Germany (floor area about 2065 cm2). Bedding in the cages were Type Lignocel PS 14, dust-free bedding, supplied by SSNIFF, Soest, Germany. Motor activity measurements were conducted in polycarbonate cages with wire covers from Ehret, Emmendingen, Germany (floor area about 800 cm2) and small amounts of bedding material (Type Lignocel PS 14, see above). For enrichment, wooden gnawing blocks (Typ NGM E-022) were added, supplied by Abedd® Lab. and Vet. Service GmbH, Vienna, Austria.
The animals were accommodated in fully air-conditioned rooms in which central air conditioning guaranteed a range of temperature of 20-24 °C, a range of relative humidity of 30-70% and 15 air changes per hour. The day/night cycle was 12 hours (12 hours light from 06.00 h-18.00 h, 12 hours dark
from 18.00 h-06.00 h). The animal room was completely disinfected prior to the study using a disinfector ("AUTEX", fully automatic, formalin-ammonia-based terminal disinfector). The floor and the walls were cleaned once a week with water containing an appropriate disinfectant.
The food used was ground Kliba maintenance diet mouse/rat “GLP” meal, supplied by Provimi Kliba SA, Kaiseraugst, Switzerland. Food and drinking water (from water bottles) were available ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The test substance was applied as a emulsion. To prepare this emusion, the appropriate amount of test substance was weighed out depending on the desired concentration. Then, drinking water was filled up to the desired volume and mixed by a magnetic stirrer. During administration of the test substance, preparations were kept homogeneous by stirring with a magnetic stirrer. The test-substance preparations were produced at least every 4th day a week.
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 300, 1000 mg/kg b.w.
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
Examinations
- Observations and examinations performed and frequency:
- Food consumption and body weights were determined weekly. The animals were examined for signs of toxicity or mortality at least once a day. In addition, the animals were examined daily for any clinically abnormal signs before and after treatment. Detailed clinical examinations in an open field were conducted prior to the start of the administration period and weekly thereafter. Clinicochemical and hematological examinations as well as urinalyses were performed towards the end of the administration period.
- Sacrifice and pathology:
- After the administration period all animals were sacrificed and assessed by gross pathology, followed by histopathological examinations.
- Other examinations:
- A functional observational battery (FOB) as well as motor activity measurements were carried out at the end of the administration period.
Results and discussion
Results of examinations
- Details on results:
- Test group 3: 1000 mg/kg bw/d
Clinical Examinations
• Salivation after treatment was observed in all animals of both sexes on several days of the study.
Clinical Pathology
• No test substance-related findings were observed.
Pathology
• Focal squamous hyperplasia was observed in the forestomach of 1 male.
• Erosion/ulcer was observed in the forestomach (margo plicatus) of 1 male and 1 female.
• Minimal focal inflammation was observed in the forestomach (margo plicatus) of 1 male.
Test group 2: 300 mg/kg bw/d
Clinical Examinations
• Salivation after treatment was observed in all male and 3 female animals on several days of the study
Clinical Pathology
• No test substance-related findings were observed.
Pathology
• No test substance-related findings were observed.
Test group 1: 100 mg/kg bw/d
Clinical Examinations
• Salivation after treatment was observed in 1 male animal on study day 3.
Clinical Pathology
• No test substance-related findings were observed.
Pathology
• No test substance-related findings were observed.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- systemic effects
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: systemic toxicity (no systemic toxicity observed, highest dose tested)
- Dose descriptor:
- NOAEL
- Remarks:
- local effects
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: local effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In conclusion, with regard to pathological findings in the forestomach the oral administration of Kerocom FM 38 by gavage over a period of 4 weeks revealed only locally signs of toxicity in male and female Wistar rats at dose levels of 1000 mg/kg bw/d. This finding was related to the irritating potential of the test substance. Salivation was considered to be related to either the bad taste of the test substance or local affection of the upper digestive tract. This finding was not considered to be an adverse and toxicologically relevant effect.
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