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EC number: 306-246-8 | CAS number: 96690-51-6
- 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
Endpoint summary
Administrative data
Description of key information
Acute toxicity (oral): LD50 > 30.0 mL/kg bw (corresponds to > 29.52 g/kg bw)
Acute toxicity (dermal): LD50 > 9.0 mL/kg bw (corresponds to > 8.856 g/kg bw)
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
- Study period:
- Oct 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Performed pre-GLP, using a method similar to OECD 401
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Performed pre-GLP, method is described clearly (refer to the "principles of method" field)
- Principles of method if other than guideline:
- - Principle of test: test material was given undiluted by gavage to groups of 10 males and 10 females in one single dose of 30 ml per kg body weight. After treatment the rats received stock diet and tap water ad libitum. The animals were observed for signs of intoxication during a 14-day period after which autopsies were carried out on the survivors.
- Short description of test conditions: The rats were housed in groups of five in screen·bottomed stainless steel cages, in a well-ventilated room, maintained at 23 ~ 1° C. Before dosing, the rats were fasted overnight. The test material was given undiluted by gavage.
- Parameters analysed / observed: signs of intoxication, deaths, gross pathology - GLP compliance:
- no
- Remarks:
- Prior to GLP
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: The Central Institute for the Breeding of Laboratory Animals, TNO, Zeist, The Netherlands
- Age at study initiation: Indicated as "young"
- Weight at study initiation: The body weights of the males varied from 170 to 198 g, those of females from 155 to 211 g.
- Fasting period before study: Overnight
- Housing: housed in groups of five in screen·bottomed stainless steel cages, in a well-ventilatedroom
- Diet: stock diet ad libitum
- Water: tab water at libitum
ENVIRONMENTAL CONDITIONS
Temperature: 23 +/- 1 C
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 30 ml per kg body weight. This dose is considered to be the highest tolerable amount to be given in one single oral dose.
- Doses:
- One single dose of 30 ml per kg
- No. of animals per sex per dose:
- 10 males, 10 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: not specified
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: - Preliminary study:
- not applicable
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 30 mL/kg bw
- Based on:
- test mat.
- Mortality:
- Out of 10 males and 10 females; 3 males and 2 females succumbed. Deaths occured between 4 hours and 2 days after dosing.
- Clinical signs:
- other: During the first few hours after dosing none of the rats showed any reaction to the treatment. Later on sluggishness, wet fur and emaciation were observed.
- Gross pathology:
- Macroscopic examination of the survivors at autopsy did not reveal any treatment-related gross alterations.
- Other findings:
- The surviving animals recovered gradually and appeared healthy at the end of the observation period.
- Interpretation of results:
- other: not classified
- Remarks:
- based on CLP criteria
- Conclusions:
- Based on the result of this study the LD50 was > 30.0 mL/kg bw (which corresponds to > 29,52 g/kg bw), Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol therefore does not need to be classified for acute oral toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
Nourypol was tested for acute oral toxicity in a study similar to OECD TG 401, performed pre-GLP, scored Klimisch 2. A single 30.0 mL/kg bw dose of "Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was administered by oral gavage to 10 male and 10 female Wistar rats. The animals were observed for 14 days while food and water were available ad libitum. During the first few hours after dosing none of the rats showed any reaction to the treatment. Later on sluggishness, wet fur and emaciation were observed. Mortality was observed in 5/20 rats (3 male and 2 female). The oral LD50 value of "Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" in rats was established as > 30.0 mL/kg bw (which corresponds to > 29,52 g/kg bw). Under the conditions of this study, the substance does not have to classified according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP)
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- comparable to guideline study with acceptable restrictions
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Performed pre-GLP, method is described briefly (refer to the "principles of method" field)
- Principles of method if other than guideline:
- - Short description of test conditions: Dermal application of Nourypol 200 at dose levels of 0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight
- Parameters analysed / observed: growth, food and water intake and haematology, as well ass Gross examination at autopsy - GLP compliance:
- no
- Remarks:
- Prior to GLP adoption
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- Not Specified
- Species:
- rabbit
- Strain:
- other: Albino
- Remarks:
- No further specification regarding the strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not specfied
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight
- Duration of exposure:
- Not specified
- Doses:
- 0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight
- No. of animals per sex per dose:
- Not specified
- Control animals:
- yes
- Remarks:
- The 0.0 ml/kg body weight (control) dosed group was used as control
- Details on study design:
- - Frequency of observations and weighing: Haeatological data was obtained 2 weeks after a single dermal appliaction. other observation frequencies are not specified.
- Necropsy of survivors performed: yes
- Other examinations performed: growth, food and water intake, haematology, gross examination - Statistics:
- not specified
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 9 mL/kg bw
- Based on:
- test mat.
- Mortality:
- No
- Clinical signs:
- other: slight skin effects at 3.0 and 6.0 ml/kg and slight to moderate skin effects at 9.0 ml/kg.
- Gross pathology:
- Gross examination at autopsy did not reveal any clearly treatment-related changes
- Interpretation of results:
- other: Not classified
- Remarks:
- Based on CLP criteria
- Conclusions:
- Under the conditions of the test, the dermal LD50 was > 9 mL/kg bw (which corresponds to > 8.856 g/kg bw). Therefore, the substance does not need to be classified for acute toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
An acute dermal toxicity study with "Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was performed in a study similar to OECD TG 402, pre-GLP, scored Klimisch 2.
"Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was tested at 0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight in albino rabbits. Duration of observation period following administration: 14 days, growth, food and water intake, haematology and gross pathology were examined. No mortality occurred, slight skin effects were seen at 3.0 and 6.0 ml/kg and slight to moderate skin effects at 9.0 ml/kg. Gross examination at autopsy did not reveal any clearly treatment-related changes. Under the conditions of the test, the dermal LD50 was > 9 mL/kg bw (which corresponds to > 8.856 g/kg bw). Therefore, the criteria laid down in Annex I of the CLP Regulation (1272/2008/EC) are not fullfilled and the substance does not need to be classified for acute toxicity.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Quality of whole database:
- comparable to guideline study with acceptable restrictions
Additional information
Acute Oral toxicity:
"Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was tested for acute oral toxicity in a study similar to OECD TG 401, performed pre-GLP, scored Klimisch 2. A single 30.0 mL/kg bw dose of "Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was administered by oral gavage to 10 male and 10 female Wistar rats. The animals were observed for 14 days while food and water were available ad libitum. During the first few hours after dosing none of the rats showed any reaction to the treatment. Later on sluggishness, wet fur and emaciation were observed. Mortality was observed in 5/20 rats (3 male and 2 female). The oral LD50 value of "Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" in rats was established as > 30.0 mL/kg bw. Under the conditions of this study, the substance does not have to classified according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP)
Acute Dermal Toxicity:
An acute dermal toxicity study with "Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was performed in a study similar to OECD TG 402, performed pre-GLP, scored Klimisch 2. "Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was tested at 0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight in albino rabbits. Duration of observation period following administration: 14 days, growth, food and water intake, haematology and gross pathology were examined. No mortality occurred, slight skin effects were seen at 3.0 and 6.0 ml/kg and slight to moderate skin effects at 9.0 ml/kg. Gross examination at autopsy did not reveal any clearly treatment-related changes. Under the conditions of the test, the dermal LD50 was > 9 mL/kg bw (which corresponds to > 8.856 g/kg bw). Therefore, the criteria laid down in Annex I of the CLP Regulation (1272/2008/EC) are not fullfilled and the substance does not need to be classified for acute dermal toxicity.
Justification for classification or non-classification
Based on the available data, "Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" does not need to be classified for acute toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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