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EC number: 232-391-0 | CAS number: 8013-07-8
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 22, 1981 - February 4, 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: May not be GLP compliant. Control animals were not mentioned. As no signs of toxicity were seen in 10 rats it is safe to assume that Soybean oil, epoxidised is not toxic therefore this deviation should not be an issue.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Conduct of the study predates formal adoption of the test guideline but in principle the OECD 401 limit method was followed. No vehicle control animals were included. The vehicle, designated PAG in the report, was not tested separately.
- Principles of method if other than guideline:
- Although pre-dating the formal guideline, the study was conducted in general concordance with a limit test as described in OECD method 401. The vehicle selected was described as PAG with no elucidation. It is assumed that it was polyethylene glycol (PEG), which was comonly used for acute gavage administration and this would explain the absence of a separate vehicle control group.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- TK 11'278
- IUPAC Name:
- TK 11'278
- Reference substance name:
- Soybean oil, epoxidized
- EC Number:
- 232-391-0
- EC Name:
- Soybean oil, epoxidized
- Cas Number:
- 8013-07-8
- Molecular formula:
- Not necessary, substance is a UVCB.
- IUPAC Name:
- Soybean oil, epoxidized
- Details on test material:
- - Name of test material (as cited in study report): TK 11278
- Physical state: Liquid
- Lot/batch No.: prod. Oct. 80
Before treatment the suspension was homogeneously dispersed with an Ultra-Turrax and during treatment it was kept stable with a magnetic stirrer.
The test material was dispersed in PAG - probably polyethylene glycol (PEG) and administered in a dose volume of 20 mL/kg bw.
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAIf (SPF) Strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Healthy random bred rats of the Tif:RAIf (SPF) strain , which were raised on the Ciba-Geigy Ltd, Basle, laboratory premises
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: male mean = 185g; female mean = 174g
- Fasting period before study: rats were fasted overnight prior to treatment
- Housing: in groups of 5 in Macrolan cages
- Diet (e.g. ad libitum): NAFAG, Gossau SG
- Water (e.g. ad libitum): potable water source not specified in report
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 14/10
IN-LIFE DATES: From: 22 January 1981 To: 4 February 1981
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: PAG. Assumed to be PEG = polyethylene glycol
- Details on oral exposure:
- The report indicates PAG was used as a vehicle (it is assumed this is a typographical error and that PEG, polyethylene glycol was actually used).
The test material was dispensed at 20 ml/kg bw.
Animals were fasted overnight and treated by single oral intubation. - Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5 animals per group
- Control animals:
- not specified
- Details on study design:
- Bodyweights were recorded immediately prior to dosing and after 7 and 14 days. Physical condition and mortality were monitored throughout the observation period.
- Statistics:
- LD50 including 95 % confidence limits are calculated by the logit model.
Results and discussion
- Preliminary study:
- Not relevant
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No confidence intervals or median lethal dose calculated for the 5g/kg bw limit test
- Mortality:
- None of the rats died
- Clinical signs:
- other: See Table 2 below Evidence of slight dyspnoea, slightly ruffled fur, slight diarrhoea and a slightly curved body position were noted primarily on Day 1 (1-24 h after administration). Some cases of ruffled fur and curved body position persisted on days 2
- Gross pathology:
- No gross organ changes were observed
- Other findings:
- No further information supplied
Any other information on results incl. tables
Table 1: Bodyweight change
|
Dose – 5000 mg/kg |
|
Mean (g) |
Standard Deviation (g) |
|
Day 1 (Male) |
185 |
1.8 |
Day 1 (Female) |
174 |
1.2 |
Day 7 (Male) |
236 |
5.1 |
Day 7 (Female) |
186 |
1.8 |
Day 14 (Male) |
289 |
5.7 |
Day 14 (Female) |
215 |
2.9 |
Table 2: Clinical Signs
Dose – 5000 mg/kg |
||||||||||||||||||
Signs and Symptoms |
Hours |
Days |
||||||||||||||||
1 |
2 |
3 |
5 |
24 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|
Sedation |
|
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Dyspnoea |
+ |
+ |
|
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Dacryorrhoea |
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Chromodacryorrhoea |
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Rinorrhoea |
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Epistaxis |
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Exophthalmos |
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Salivation |
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Ruffled fur |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
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Pallor |
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Cyanosis |
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Diarrhoea |
|
+ |
+ |
+ |
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Body Position (ventral) |
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Body Position (lateral) |
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Body Position (curved) |
+ |
+ |
+ |
+ |
+ |
+ |
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Ataxia |
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Trismus |
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Tremor |
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Tonic clonic muscle spasms |
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Convulsions |
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+ = slight
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 of TK 11'278 in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg. The test material is therefore practically non toxic to the rat by this route of administration. According to Directive 67/548/EEC, no classification is warranted. According to Regulation (EC) No. 1272/2008, no classification is warranted.
- Executive summary:
The acute oral LD50 of TK 11'278 in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg. The test material is therefore practically non toxic to the rat by this route of administration. According to Directive 67/548/EEC, no classification is warranted. According to Regulation (EC) No. 1272/2008, no classification is warranted.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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