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EC number: 413-330-9 | CAS number: 134724-55-3
- 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
The acute oral LD50 of FAT 40554 in rats is greater than 5000 mg/kg and the acute dermal LD50 in rabbits is greater than 2000 mg/kg.
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:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Charles River U.K. Ltd., Margate, kent, England.- Age at study initiation: 7 weeks old approximately- Weight at study initiation: 160 g - 197 g- Housing: HRC cage type 5 - cages with wire mesh floors - Diet (e.g. ad libitum): standard laboratory rodent diet (Biosure LAD 1) ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: 7 days prior to the start of the main studyENVIRONMENTAL CONDITIONS- Temperature (°C): 21°C - 23°C- Humidity (%): 44 %H- Air changes (per hr): 15 air changes per hour- Photoperiod (hrs dark / hrs light): 12 hours artificial light in each 24 hour period
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- None
- Doses:
- 5000 mg / kg bodyweight
- No. of animals per sex per dose:
- 10 (5 males & 5 females)
- Control animals:
- not specified
- Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: day 1, 8 & 15- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: macroscopic appearance eaxmined
- Statistics:
- None
- Preliminary study:
- The results of the preliminary study indicated that the acute lethal dose to male and female rats of D-523 was greater than 2.5 g/kg bodyweight.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- There were no deaths following a single oral dose of D-523 at 5.0 g/kg bodyweight.
- Clinical signs:
- Signs of toxicity related to dose levels:Piloerection was noted in all rats within 5 minutes of dosing and throughout day 1. All animals showed the expected gains in bodyweight over the study period.
- Body weight:
- Slightly low bodyweight gains were recorded on Day 15 for one male and 4 females; these animlas achieved anticipated gains on Day 8. All other rats achieved anticipated bodyweight gains throughout the study.
- Gross pathology:
- Terminal autopsy revealed no macroscopic abnormalities for the majority of rats. Unilateral hydronephrosis was apparent for one male on Day 15. A slow incidence of this abnormality occurs spontaneously among untreated rats of the CD starin at this laboratory, the finding was not considered to be related to treatment.
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The results of the main study indicated that the acute lethal dose to male and female rats of FAT 40554 was greater than 5000 mg/kg bodyweight.
- Executive summary:
The aim of this study was to determine the acute oral toxicity potency of FAT 40554 in rats after single administartion by oral gavage.
This experiment was performed according to the EU Method B.1 (Acute Toxicity (Oral))
The test was performed on rats (5 males and 5 females) per dose level, at one dose level: 5000 mg/kg.
The test material was dissolved in distilled water.
The observation period was 14 days or until all symptoms have disappeared, whichever lasts longer.
Mortality:
No mortality occured during the experiment.
Body weight:Normal weight gain.
Signs of toxicity: Piloerection was noted in all rats within 5 minutes of dosing and throughout day 1. All animals showed the expected gains in bodyweight over the study period.
Effects in organs: Terminal autopsy revealed no macroscopic abnormalities for the majority of rats. Unilateral hydronephrosis was apparent for one male on Day 15. A slow incidence of this abnormality occurs spontaneously among untreated rats of the CD starin at this laboratory, the finding was not considered to be related to treatment.
In conclusion, the median lethal dose is found to be greater than 5000 mg/kg bodyweight.
Reference
INDIVIDUAL BODUWEIGHT CHANGES (g) OF RATS DOSED WITH D-523:
Sex | Dose (g/kg) | Animal number & ear mark | Bodyweight gains (g) at | |
Week 1 | Week 2 | |||
Male | 5 | 1 RP | 76 | 50 |
2LP | 90 | 66 | ||
3RPLP | 100 | 74 | ||
4RIRO | 95 | 63 | ||
5LILO | 90 | 56 | ||
Female | 5 | 6RP | 54 | 8 |
7LP | 58 | 16 | ||
8RPLP | 37 | 4 | ||
9RIRO | 36 | 9 | ||
10LILO | 61 | 1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
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:
- 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- None
- Species:
- rat
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Charles river Japan- Age at study initiation: 6 weeks old- Weight at study initiation: 243 to 272g for males & 156 to 173g for females- Housing: rectangular suspension cage with a stainless steel wire mesh floor- Diet (e.g. ad libitum): laboratory animal chows (CRF-1, sterilised by CO irradiation, Oriental Yeast Co. Ltd.) ad libitum- Water (e.g. ad libitum): free access to tap water ad libitum- Acclimation period: 8 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 24+-2°C- Humidity (%): 55+-10%- Air changes (per hr): 10 times per hour- Photoperiod (hrs dark / hrs light): fluorescent lighting system - 12 hours light/dark cycle
- Type of coverage:
- occlusive
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on dermal exposure:
- The suspension was spread over the shreaded area (30 cm2) using a plastic syringe (2.5ml) and an attached gastric metal probe with a plastic tip (1.2 mm in diameter, 80 mm in length) at the dosing volume of 10 ml/lg body weight. The treated area was then covered with surgical tape to prevent the animals from licking the test material from the treated area.
- Duration of exposure:
- 24 hours
- Doses:
- The test material was suspended in 0.5% methylcellulose aqueous solution (MC) at the concentration of 200 mg/ml.
- No. of animals per sex per dose:
- 5 animals per group
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days - Frequency of observations and weighing: 1, 2 and 4 hours after administration on the first day and once daily for 2 weeks thereafter- Necropsy of survivors performed: yes- Other examinations performed: clinical signs, body weight,organ weights, histopathology
- Statistics:
- The mortality and LD50 values were calculated.
- Preliminary study:
- None
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in the animals
- Clinical signs:
- No abnormal signs were observed.
- Body weight:
- There was no difference in the mean body weight and the mean body weight gain between treated groups and the control group at every determination.
- Gross pathology:
- Retention of white substances in the urinary bladder (male) and distended uterine horns with fluid retention were found in several animals including controls. These changes have been occasionally found in untreated rats in this laboratory.No skin irritative reaction was observed at the application site. Therefore, no remarkable change related to the administration of the test material was found.
- Other findings:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In conclusion, FAT 40554 did not show acute dermal toxicity.
- Executive summary:
An acute dermal toxicity test of D-523 was examined in rats according to EU Method B.3 (Acute Toxicity (Dermal).
5 animals per group were administered the suspension with a dose of 200 mg/ml in 0.5% methylcellulose aqueous solution (MC).
Neither abnormal signs nor dead animals were found in any group among animals of either sex, and the acute dermal LD50 value for both males and females was estimated to be greater than 2000 mg/kg body weight.
The body weight was not affected by the administration of the test material. In gross pathology, there was neither a remarkable change related to the test material nor a skin irritative reactions at the application site in any animal.
Therefore, the FAT 40554 did not show any acute dermal toxicity in animals.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Acute Oral Toxicity:
A key study was performed to determine the acute oral toxicity potency of FAT 40554 in rats after single administartion by oral gavage.
This experiment was performed according to the EU Method B.1 (Acute Toxicity (Oral).
No mortality occurred during the experiment with normal weight gain. Piloerection was noted in all rats within 5 minutes of dosing and throughout day 1. All animals showed the expected gains in bodyweight over the study period. Terminal autopsy revealed no macroscopic abnormalities for the majority of rats. Unilateral hydronephrosis was apparent for one male on Day 15. A slow incidence of this abnormality occurs spontaneously among untreated rats of the CD strain at this laboratory, the finding was not considered to be related to treatment.
In conclusion, the median lethal dose is found to be greater than 5000 mg/kg bodyweight.
Acute Dermal Toxicity:
An acute dermal toxicity of D-523 was examined in rats according to EU Method B.3 (Acute Toxicity (Dermal).
5 animals per group were administered the suspension with a dose of 200 mg/ml in 0.5% methylcellulose aqueous solution (MC).
Neither abnormal signs nor dead animals were found in any group among animals of either sex, and the acute dermal LD50 value for both males and females was estimated to be greater than 2000 mg/kg body weight. The body weight was not affected by the administration of the test material. In gross pathology, there was neither a remarkable change related to the test material nor a skin irritative reactions at the application site in any animal.
Therefore, the FAT 40554 did not show any acute dermal toxicity in animals.
Justification for selection of acute toxicity – oral endpoint
GLP guideline study
Justification for selection of acute toxicity – dermal endpoint
Non GLP guideline study
Justification for classification or non-classification
Based on the above mentioned results the substance does not need to be classified according to CLP regulation (Regulation EC No.1272/2008) and DSD (Directive 67/548/EEC).
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