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EC number: - | CAS number: -
- 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:
- Study initiation date - 24 February 2021; Experiment start date - 25 February 2021; Experiment completion date - 25 March 2021; Study completion date - 23 June 2021.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- See "Any other information on materials and methods incl. tables"
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Test Item: FAT 75637/B TE
Physical Appearance: Light yellow powder
Purity: 99.4 % all organic constituents; 95.0 % main constituent
Batch No: AT-0063765400
Manufactured Date: 21st April 2020
Expiry Date: May 27th, 2025
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Rats were housed under standard laboratory conditions, air conditioned with adequate fresh air supply (14.5 to 14.9 air changes/hour). Environment: temperature 21 to 24 °C, relative humidity 65 to 67 %, 12 hours light and 12 hours dark cycle. The maximum and minimum temperature and relative humidity in the experimental room were recorded once daily. The relative humidity in the experimental room was calculated from dry and wet bulb temperature recordings.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Milli-Q water
- Details on oral exposure:
- Groups of animals of a single sex are dosed in a stepwise procedure using the fixed doses of 300 and 2000 mg/kg. The initial dose level was selected on the basis of a sighting study as the dose expected to produce some signs of toxicity without causing severe toxic effects or mortality. Further groups of animals were dosed at higher dose depending on the presence or absence of the signs of toxicity or mortality. This procedure continues until the dose causing evident toxicity or no more than one death is identified or when no effects are seen at the highest dose or when deaths occur at the lowest dose.
- Doses:
- As there was no complete available toxicology information about test item. Hence, the study was initiated with starting dose of 300 mg/kg body weight as sighting study. The test was started as per Annex 2 of the OECD Test guideline. Based on result of sighting study the main study was performed by using 4 animals of same sex.
- Control animals:
- no
- Details on study design:
- The dose formulation was prepared by using Milli-Q water and administered as a single oral gavage to overnight fasted (16 to 18 hours) female rat (G1-sighting study) at the dose of 300 mg/kg body weight. The rat was normal and there was no pre-terminal death observed. based on the treatemnt schedule, the treatment was started by dosing one female rat at the dose of 2000 mg/kg body weight (G2- sighting study). The rat was normal and there was no pre-terminal death observed. Hence, treatment was continued by dosing four additional female rats at the higher dose of 2000 mg/kg body weight (G2-main study). All rats were normal and there were no pre-terminal death observed. The prepared dose formulation was administered at the dose volume of 10 mL/kg bodyweight. The rats were observed for mortality and clinical signs for 14 days post treatment. Body weights were recorded prior to dosing on day 1 and again on days 8 and 15. Necropsy was performed for all the surviving rats. All surviving rats gained weight during experimental period. There were no gross pathological changes observed at necropsy.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no pre-terminal deaths.
- Clinical signs:
- other: There were no clinical signs
- Gross pathology:
- There were no gross pathological changes at necropsy in the terminal sacrifice rats
Any other information on results incl. tables
Body weight:
Group and Dose (mg/kg body weight) |
Rat No. |
Sex | Body weight (g) |
No. dead/ No. tested |
Pre-terminal deaths (%) | |||||
Initial (Day 1) |
8th day | Weight change (day 8 – Initial) |
15th day | Weight change (day 15 – Initial) |
At Death | |||||
G1(Sighting study) 300 | Rw8001 | F | 230.1 | 245.4 | 15.3 | 260.1 | 30.0 | NA | 0/1 | 0 |
G2 (Sighting study) 2000 | Rw8002 | F | 249.9 | 263.5 | 13.6 | 274.8 | 24.9 | NA | 0/1 | 0 |
G2 (Main study) 2000 | Rw8003 | F | 240.1 | 252.8 | 12.7 | 268.4 | 28.3 | NA |
0/4 | 0 |
Rw8004 | F | 229.8 | 240.7 | 10.9 | 257.3 | 27.5 | NA | |||
Rw8005 | F | 227.0 | 238.8 | 11.8 | 256.8 | 29.8 | NA | |||
Rw8006 | F | 239.2 | 250.1 | 10.9 | 265.8 | 26.6 | NA |
Summary of stability and homogeneity test
Stability results
Test Item Name: FAT 75637/B; Test Item Code:H009-1; Study No:G20923; Vehicle : Milli-Q Water
Experimental Period: 24 hours
Claimed Concentration (mg/mL) | Sampling Time Point (hour) | Analyzed Test Item Concentration (mg/mL) | Analyzed Test Item Conc(mg/mL) (Mean ± SD) %RSD | % Change over ‘0’ day | |||||
Top | Middle | Bottom | |||||||
R 1 | R 2 | R 1 | R 2 | R 1 | R 2 | ||||
0.025 | 0 | 0.019 | 0.020 | 0.019 | 0.019 | 0.018 | 0.019 | 0.02 ± 0.001 (5.26) | NA |
24 | 0.019 | 0.017 | 0.017 | 0.017 | 0.019 | 0.019 | 0.02 ± 0.001 (5.36) | 0.00 | |
250.13 | 0 | 230.6 | 239.5 | 230.4 | 224.4 | 239.2 | 233.5 | 232.9 ± 5.79 (2.49) | NA |
24 | 254.0 | 251.3 | 254.0 | 252.2 | 263.2 | 254.4 | 254.9 ± 4.27 (1.67) | 9.45 | |
Acceptance criteria: Stability of the formulations was considered acceptable if mean results are within ± 15.0% from the mean initial stability (homogeneity) time point and formulations will be considered re-suspendable if mean %RSD is equal to or less than 10.0% |
Where, R = replication, NA = Not applicable
Conclusion: The test item, FAT 75637/B was observed to be stable in the vehicle at dose concentrations of 0.025 and 250.13 mg/mL up to 24 hours when stored at room temperature.
Homogeneity results Test Item Name: FAT 75637/B
Claimed concentration (mg/mL) |
Layer | Analyzed test item concentration (mg/mL) | Mean % agreement with claimed concentration in each layer | Overall mean ± s.d. of analyzed testitem concentration (mg/mL) | Accuracy of overall mean of each dose (%) | Overall %RSD | ||
R1 | R2 | Mean | ||||||
0.0205 | Top | 0.019 | 0.020 | 0.02 | 95.1 | 0.019 ± 0.001
| 92.7 | 3.334 |
Middle | 0.019 | 0.019 | 0.02 | 92.7 | ||||
Bottom | 0.018 | 0.019 | 0.02 | 90.3 | ||||
250.13 | Top | 230.6 | 239.5 | 235.1 | 94.0 | 232.9 ± 5.79 | 93.1 | 2.490 |
Middle | 230.4 | 224.4 | 227.4 | 90.9 | ||||
Bottom | 239.2 | 233.5 | 236.4 | 94.5 |
Note: R1, R2 denote replications
*Overall mean ± s.d. should be calculated using all the replicate values of all the layers.
Conclusion: The test item, FAT 75637/B was observed to be homogeneous in the vehicle at dose concentrations of 1.038 and 250.1 mg/mL
Dose Formulation Analysis Results
Study No: G20923 Study Code : AOR Date of analysis: 11 February 2021
Claimed Conc. | Sample code | Analyzed (mg/mL) | Mean Analyzed | Concentration | % Agreement with Claimed Conc. | Mean % Agreement with Claimed Conc. in each layer | % Agreement | ||||
Mean Analyzed Conc (mg/mL) | SD | % RSD | Mean of % Agreement with Claimed Conc. | SD | % RSD | ||||||
200 | G1TR1 | 191.7 | 1932 | 197.8
| 4.89
| 2.47 | 95.8 | 96.6 | 98.9
| 2.44
| 2.47 |
G1TR2 | 194.8 | 97.4 | |||||||||
G1MR1 | 195.3 | 197.8 | 97.6 | 98.9 | |||||||
G1MR2 | 200.3 | 100.1 | |||||||||
G1BR1 | 199.6 | 202.5 | 99.8 | 101.2 | |||||||
G1BR2 | 205.4 | 102.7 | |||||||||
Acceptance Criteria: Formulations will be considered acceptable if the mean results (calculated using all the replicate values) of all the layers and mean of each layer are within ±15.0 % of the claimed concentration and the relative standard deviation (% RSD, calculated using all the replicate values) of assay of top, middle and bottom layers (RSD) is equal to or less than 10.0 %. |
Note: No peak was detected at the retention time of the analyte in the vehicle sample. The obtained results were within the acceptance criteria
Individual clinical signs, dose administration and necropsy findings
Group and Dose (mg/kg body weight) | Date and time of administration | Rat No. | Sex | Body weight (Day 1) (g) | Total volume administered (mL) | Day of observation | ||||
Day 1 | ||||||||||
30 min | 1hour | 2 hours | 3 hours | 4 hours | ||||||
G1 (Sighting study) 300 | 03 March 2021 11:40 AM to 11:41 AM
| Rw8001 | F | 230.4 | 2.3 | N | N | N | N | N |
G2 (Sighting study) 2000 | 09 March 2021 11:52 AM to 11:53 AM
| Rw8002 | F | 249.9 | 2.5 | N | N | N | N | N |
G2 (Main study) 2000 | 11 March 2021 12:02 AM to 12:03 AM | Rw8003 | F | 240.1 | 2.4 | N | N | N | N | N |
Rw8004 | F | 229.8 | 2.3 | N | N | N | N | N | ||
Rw8005 | F | 227.0 | 2.3 | N | N | N | N | N | ||
Rw8006 | F | 239.2 | 2.4 | N | N | N | N | N |
F: Female N: Normal min: minutes mg: milligrams kg: kilograms mL: millilitre NAD: No Abnormality Detected
Individual clinical signs, dose administration and necropsy findings:
Group and Dose (mg/kg body weight) | Rat No. | Sex | Day of observation | NecropsyFindings | |||||||||||||
2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | 15 | ||||
G1 (Sighting study) 300 | Rw8001
| F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | NAD |
G2 (Sighting study) 2000 | Rw8002
| F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | NAD |
G2 (Main study) 2000 | Rw8003
| F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | NAD |
Rw8004
| F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | NAD | |
Rw8005
| F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | NAD | |
Rw8006
| F | N | N | N | N | N | N | N | N | N | N | N | N | N | N | NAD |
F: Female N: Normal min: minutes mg: milligrams kg: kilograms mL: millilitre NAD: No Abnormality Detected
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the present study, the LD50 of test item, FAT 75637/B TE is greater than 2000 mg/kg body weight.
- Executive summary:
The acute oral toxicity study with FAT 75637/B in Wistar rats was conducted to assess the toxicological profile of the test item. This study was conducted according to OECD test guideline 420 in a GLP certified laboratory. The dose formulation was prepared by using Milli-Q water and administered as a single oral gavage to overnight fasted (16 to 18 hours) female rat (G1-sighting study) at the dose of 300 mg/kg body weight. The rat was normal and there was no pre-terminal death observed. According to the treatment schedule, the treatment was started by dosing one female rat at the dose of 2000 mg/kg body weight (G2- sighting study). The rat was normal and there was no pre-terminal death observed. Hence, the treatment was continued by dosing four additional female rats at the higher dose of 2000 mg/kg body weight (G2-main study). All rats were normal and there were no pre-terminal death observed. The prepared dose formulation was administered at the dose volume of 10 mL/kg body weight. The rats were observed for mortality and clinical signs for 14 days post treatment. Body weights were recorded prior to dosing on day 1 and again on days 8 and 15. Necropsy was performed for all the surviving rats. All surviving rats gained weight during experimental period. There were no gross pathological changes observed at necropsy. The dose formulation analysis was performed for the G1-(300 mg/kg body weight) and G2-(2000 mg/kg body weight). The obtained results of dose formulation analysis for 30 mg/mL and 200 mg/mL were found to be with in the acceptable limit (85-115 %). Based on the results of the present study, The LD50 of test item, FAT 75637/B is greater than 2000 mg/kg body weight.
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