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EC number: 919-701-6 | CAS number: 503157-00-4
- 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:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD guideline 423 and in accordance with GLP
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:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Principles of method if other than guideline:
- Guidelines followed
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Environment: with temperature 21 to 23°C, relative humidity 65 to 67%, with 12 hours light and 12 hours dark cycle.
Animals were housed individually in standard polysulfone cages
(Size: approximately L 425 x B 266 x H 175 mm), with stainless steel top grill having facilities for pelleted food and drinking water in polycarbonate bottle.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Milli-Q water
- Details on oral exposure:
- VEHICLE, Milli-Q water was used as vehicle to prepare the test item suspension.
MAXIMUM DOSE VOLUME ADMINISTERED: 10 mL/kg body weight
DOSAGE PREPARATION (if unusual):
The test item formulation was prepared on each day of the test item administration.
G1 - [2000 mg/kg body weight - Treatment (FTS and STS)] : A quantity of 5.53# (5.0x1.106) g of test item was weighed in a mortar and mixed by adding small volume of Milli-Q water and stirred by using a pestle. The content was then transferred to a measuring cylinder. The mortar was rinsed again with Milli-Q water and the rinsing was transferred to the measuring cylinder. The mortar was rinsed with vehicle and the rinsing was then transferred to the measuring cylinder. The volume was made up to 25 mL to get the test item concentration of 200 mg/mL suspension.
Homogeneity of the test item in the vehicle was maintained by constant stirring using glass rod. Preparations were made prior (within 1 hour) to dosing.
The preparation corresponding only to the first step of each dose was sent for analysis.
#: While calculating the required weight of test item for preparation of dose formulation, purity correction factor of 1.106 was applied. While calculating the concentration of the prepared dose formulation, a correction factor of 1/1.106 was applied, which was calculated as below:
Purity correction = 100/90.4 = 1.106 - Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:day 1, day 7 and day 14.
- Necropsy of survivors performed: yes
The rats surviving to the end of the observation period were euthanised using isoflurane anaesthesia and subjected to detailed necropsy by an experienced prosector and the findings were recorded in raw data. Microscopic examination was not carried out as no gross pathological changes were observed.
- Clinical Signs and Pre-Terminal Deaths :
The animals were observed five times on test day 1 (day of administration) i.e. at 30 minutes and four times at hourly intervals and once daily during days 2 to 15 post administration.
Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern. Attention was directed to the observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma and findings of all observations were recorded.
-Body Weights
The body weights were recorded on test day 1 (pre-administration), day 8 (7 days post administration) and day 15 (14 days post administration).
-Necropsy
The rats surviving to the end of the observation period were euthanised using isoflurane anaesthesia and subjected to detailed necropsy by an experienced prosector and no abnormalities were observed at Nectopsy. - Statistics:
- None
Results and discussion
- Preliminary study:
- None
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Non toxic
- Mortality:
- No data
- Clinical signs:
- G1 - [2000 mg/kg body weight - Treatment (FTS and STS)]: There were no clinical signs were observed, however reddish brown faeces was observed in all rats on day 2, the change in colour is due to the colour of the test item. All the rats were normal from day 3 onwards. There were no pre-terminal deaths.
- Body weight:
- G1 - [2000 mg/kg body weight - Treatment (FTS and STS)]: The body weights of all the rats increased throughout the observation period.
- Gross pathology:
- No abnormality was detected at necropsy.
- Other findings:
- None
Any other information on results incl. tables
TABLE 1. Body weight, Body weight change and Pre-terminal deaths
Group and Dose (mg/kg body weight) |
Rat No. |
Sex |
Body weight (g) |
No. dead/ No. tested |
||||
Initial (Day 1) |
8thday |
Weight change (day 8 – Initial) |
15thday |
Weight change (day 15 – Initial) |
||||
G1 (FTS) 2000 |
Rm2811 |
F |
208.3 |
213.0 |
4.7 |
220.4 |
12.1 |
0/3
|
Rm2812 |
F |
195.6 |
208.1 |
12.5 |
217.8 |
22.2 |
||
Rm2813 |
F |
205.7 |
215.2 |
9.5 |
223.2 |
17.5 |
||
G1 (STS) 2000 |
Rm2814 |
F |
210.2 |
215.1 |
4.9 |
221.8 |
11.6 |
0/3
|
Rm2815 |
F |
212.3 |
216.8 |
4.5 |
223.1 |
10.8 |
||
Rm2816 |
F |
195.7 |
200.3 |
4.6 |
207.6 |
11.9 |
F: Female; FTS: First Treatment Step; STS: Second Treatment Step
APPENDIX 1. Individual Toxic Signs and Necropsy Findings
Group: G1 (FTS) Dose: 2000 mg/kg body weight
Rat No. |
Sex |
Total volume admin (mL) |
Day of Observation |
Necropsy Findings |
||||||||||||||||||
Day 1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||||||
30 min |
1hour |
2 hours |
3 hours |
4 hours |
||||||||||||||||||
Rm2811 |
F |
2.1 |
N |
N |
N |
N |
N |
RBF |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
Rm2812 |
F |
2.0 |
N |
N |
N |
N |
N |
RBF |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
Rm2813 |
F |
2.1 |
N |
N |
N |
N |
N |
RBF |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
F: Female; FTS: First Treatment Step; N: Normal; admin: administered; min: minutes;
mL: millilitre NAD: No Abnormality Detected RBF : Reddish Brown Faeces
Group: G1 (STS) Dose: 2000 mg/kg body weight
Rat No. |
Sex |
Total volume admin (mL) |
Day of Observation |
Necropsy Findings |
||||||||||||||||||
Day 1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||||||
30 min |
1hour |
2 hours |
3 hours |
4 hours |
||||||||||||||||||
Rm2814 |
F |
2.1 |
N |
N |
N |
N |
N |
N@ |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
Rm2815 |
F |
2.1 |
N |
N |
N |
N |
N |
N@ |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
Rm2816 |
F |
2.0 |
N |
N |
N |
N |
N |
N@ |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
F: Female; STS: Second treatment step; N: Normal; admin: administered; min: minutes;
mL: millilitre NAD: No Abnormality Detected @: Reddish Brown Faeces
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Based on the results of the present study, the test item, FAT 40866/A TE is classified as follows:
-“Category 5” or Unclassified as per Globally Harmonized Classification system of Annex 2d of the Guideline, OECD 423.
- The LD50 is 5000 mg/kg body weight or Unclassified as per LD50 cut-off value. - Executive summary:
The study was performed to access the acute oral toxicity of test item, FAT 40866/A TE in Wistar rats.
The test item mixed in Milli-Q water was administered as oral gavage to overnight fasted (16 to 18 hours) 3 female rats at the dose of 2000 mg/kg body weight (G1-FTS). There were no clinical signs of toxicity and pre-terminal deaths. Based on the scheme - Annex 2d of the guideline OECD 423, three additional female rats were tested at the same dose of 2000 mg/kg body weight (G1-STS). There were no clinical signs of toxicity and pre-terminal deaths.
All rats gained weight during experimental period. The rats were subjected to necropsy at termination and there were no abnormalities detected at necropsy.
Based on the results of the present study, the test item, FAT 40866/A TE is classified as follows:
“Category 5” or Unclassified as per Globally Harmonized Classification system of Annex 2d of the Guideline, OECD 423.
The LD50 is 5000 mg/kg body weight or Unclassified as per LD50 cut-off value.
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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