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EC number: 406-640-0 | CAS number: 136920-07-5 KEROFLUX ES 3241
- 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
Description of key information
oral
rat: LD50 > 2200 mg/kg bw, no mortalities (GLP, OECD 401, BASF 1991)
dermal
rat: LD50 > 2000 mg/kg bw, no mortalities (GLP, OECD 402, BASF 1991)
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, D
- Age at study initiation: Young adult animals
- Weight at study initiation: 187 (m); 179 (f); no more than +/-10% of the mean weight
- Fasting period before study: at least 16 h
- Housing: single in stainless steel wire mesh cages, Type DK-III
- Diet: KLIBA-Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, CH; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 44 g/100 mL
- Justification for choice of vehicle: Poor solubility of the test substance in aqua dest.
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw - Doses:
- 2200 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Observation period was 14 days. Body weight determination: Individual body weights shortly before application, weekly thereafter and at the end of the study. Recording of signs and symptoms several times on the day of administration, at least once each working day for the individual animals.
A check for general observations and mortality was made twice each working day and once on saturdays, sundays and public holidays. Necropsy was done at the last day of the observation period. Withdrawal of food at least 6 h before deaths with CO2; then necropsy with gross-pathology examination. Necropsy of all animals that died before as early as possible. - Statistics:
- -
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 200 mg/kg bw
- Mortality:
- No mortality
- Clinical signs:
- other: Male animals: dyspnoe, staggering, piloerection, impaired general state and additionally in one male animal apathy and poor general state. The male animals were normal at about 1 - 6 days after application. Female animals: piloerection on the day of appli
- Gross pathology:
- No abnormalities observed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The substance does not show significant acute toxicity. Therefore a classification is not warranted according to 67/548/EEC or UN-GHS.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 200 mg/kg bw
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, D
- Age at study initiation: Young adult animals
- Weight at study initiation: 200 - 300 g; +-20% of the mean weight
- Housing: single in stainless steel wire mesh cages, Type DK-III
- Diet: KLIBA-Labordiaet 343, Klingentalmuehle AG, Kaiseraugst, CH; ad libitum
- Water: tap water; ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Single application of 2.2 ml/kg bw (density 0.908 g/mL) to the clipped epidermis (dorsal and dorsolateral parts of the trunk); covering of the application site with a semiocclusive dressing for 24 hours, afterwards removal of the dressing. Rinsing of the application site with warm water.
Clipping of the fur: at least 15 hours before the beginning of the study. - Duration of exposure:
- single application for 24 h
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- Observation period: 14 days
Body weight determination: Individual body weights shortly before application, weekly thereafter and at the end of the study period.
Signs and symptoms: Recording several times on the day of administration, at least once each working day for the individual animals.
Scoring of skin findings: Individual readings 30 - 60 min after removal of the semiocclusive dressing, weekly thereafter and at the and of the study period.
General observations and mortality: A check was made each working day and once on saturdays, sundays and on public holidays for general observations and for any dead or moribund animals.
Pathology: Necropsy at the last day of the observation period. Withdrawal of food at least 16 hours before death with CO2; then necropsy with gross-pathology examination. Necropsy of all animals that died before as early as possible. - Statistics:
- -
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortalities observed.
- Clinical signs:
- other: No abnormalities observed.
- Gross pathology:
- No pathologic findings noted.
- Other findings:
- No local abnormalities observed.
- Interpretation of results:
- GHS criteria not met
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Oral
In an acute oral toxicity limit test following GLP requirements and according to OECD test guideline 401, groups of five fasted, young adult Wistar rats per sex were given a single oral dose of Keroflux ES 3241 (purity not reported) in olive oil at a dose of 2200 mg/kg bw in 5mL/kg bw and observed for 14 days (BASF AG 1991). No mortalities, irregular body weight changes or necropsy findings were observed. Dyspnoe, staggering, piloerection, impaired general state and apathy were the observed reversible clinical signs.The oral LD50 is therefore considered to be >2200 mg/kg bw.
Dermal
In an acute dermal limit test following GLP requirements and according to OECD test guideline 402, groups of five young adult Wistar rats per sex were dermally exposed to Keroflux ES 4132 (unchanged; purity not reported) for 24 h under semiocclusive conditions at a dose of 2000 mg/kg bw. Animals then were observed for 14 days. No mortalities, irregular body weight changes, clinical signs, local effects or necropsy findings were observed. The dermal LD50 is therefore considered to be >2000 mg/kg bw.
Inhalation
No route of exposure
Justification for classification or non-classification
No classification for acute oral or dermal toxicity according to 67/548/EEC and 1272/2008/EEC, respectively, is warranted since no specific signs of toxicity were observed at doses of 2200 or 2000 mg/kg bw.
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