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EC number: 800-760-0 | CAS number: 68139-89-9
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- (17th Dec. 2001)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- (30th May 2008)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C14-18 and C16-18-unsatd., maleated
- EC Number:
- 288-306-2
- EC Name:
- Fatty acids, C14-18 and C16-18-unsatd., maleated
- Cas Number:
- 85711-46-2
- IUPAC Name:
- 85711-46-2
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS: CRL:(WI) rats
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld
- Age at study initiation: adult rats, 8 weeks old
- Weight at study initiation: 192 – 207 g
- Fasting period before study: the night before treatment (water ad libitum)
- Housing: 3 animals / cage (Type II polypropylene/polycarbonate)
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 (+/- 3)
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/ml
- Amount of vehicle (if gavage): 10 ml/kg b.w.
MAXIMUM DOSE VOLUME APPLIED: ca. 2 ml
DOSAGE PREPARATION: The test material mixed with the vehicle was warmed up on a water bath to 50 ºC for approximately 10 minutes thus facilitating preparation of a suitable dose formulation. Pending administration to the animals, the dose formulation was stirred on a magnetic stirrer at room temperature and was protected from light. - Doses:
- 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 2 x 3 female rats /2000 mg/kg b.w. (incl. the confirmatory group)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of clinical observations: 30 min., 1, 2, 3, 4, 6 h after administration, daily for 14 days
weighing: day before treatment (day -1), day of treatment prior to dosing (day 0) and than weekly
- Necropsy of all animals performed: yes
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no deaths
- Mortality:
- no mortality
- Clinical signs:
- other: Treatment with WS400104 at the dose of 2000 mg/kg bw caused transient decreased activity, hunched back and incoordination in all of six animals on the day of treatment. All animals recovered on Day 1.
- Gross pathology:
- No macroscopic observed effects
Any other information on results incl. tables
Table 1: CLINICAL OBSERVATIONS:DOSE: 2000mg/kg b.w., Treatment on Day 0
CageNo. |
Animal Number |
Observations |
Observationdays |
|
|||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6-14 |
|||||||||
30' |
1h |
2h |
3h |
4h |
6h |
||||||||||
1 |
1176 |
SymptomFree |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
|
Activitydecreased |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
|
||
Hunchedback |
- |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
|
||
Incoordination |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
|
||
1177 |
SymptomFree |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
|
|
Activitydecreased |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
|
||
Hunchedback |
- |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
|
||
Incoordination |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
|
||
1178 |
SymptomFree |
- |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
|
|
Activitydecreased |
1 |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
|
||
Hunchedback |
- |
+ |
+ |
+ |
+ |
+ |
- |
- |
- |
- |
- |
- |
|
||
Incoordination |
1 |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
|
||
2 |
1179 |
SymptomFree |
+ |
- |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
|
Activitydecreased |
- |
- |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
|
||
Hunchedback |
- |
- |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
|
||
Incoordination |
- |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
|
||
1180 |
SymptomFree |
+ |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
|
Activitydecreased |
- |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
|
||
Hunchedback |
- |
- |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
|
||
Incoordination |
- |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
|
||
1181 |
SymptomFree |
+ |
- |
- |
- |
- |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
|
|
Activitydecreased |
- |
- |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
|
||
Hunchedback |
- |
- |
+ |
+ |
- |
- |
- |
- |
- |
- |
- |
- |
|
||
Incoordination |
- |
1 |
1 |
1 |
1 |
- |
- |
- |
- |
- |
- |
- |
|
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item WS400104 was found to be above 2000 mg/kg bw in female CRL:(WI) rats.
According to the Globally Harmonised System (GHS) (UNITED NATIONS 2005 and more recent revisions) and according to [DIRECTIVE 67/548/EEC] and [Regulation (EC) No 1272/2008] WS400104 should be ranked as "Unclassified" for acute oral exposure.
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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