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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
FAT 40554 is considered as non-irritant on skin and eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Test system:
- other: dermal application
- Source species:
- rabbit
- Source strain:
- New Zealand White
- Details on animal used as source of test system:
- TEST ANIMALS- Source: Kitayama Labes Co., Ltd., Japan- Age at study initiation: 9 -10 weeks old- Weight at study initiation: 2.42 - 2.90 kg- Housing: Individually housed in aluminium cages.- Diet (e.g. ad libitum): 100 g/day diet (RC-4, Oriental Yeast Co., Ltd)- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: 25- 26 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +-2 °C- Humidity (%): 55 +- 15%- Air changes (per hr): 10 times per hour- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
- Justification for test system used:
- None
- Vehicle:
- water
- Details on test system:
- None
- Amount/concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 10gm mixed with 10ml water- Concentration (if solution): 0.75 mlVEHICLE- Amount(s) applied (volume or weight with unit): 10ml water
- Duration of treatment / exposure:
- 72 hours
- Duration of post-treatment incubation (if applicable):
- None
- Number of replicates:
- None
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: Kitayama Labes Co., Ltd., Japan- Age at study initiation: 9 -10 weeks old- Weight at study initiation: 2.42 - 2.90 kg- Housing: Individually housed in aluminium cages.- Diet (e.g. ad libitum): 100 g/day diet (RC-4, Oriental Yeast Co., Ltd)- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: 25- 26 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 +-2 °C- Humidity (%): 55 +- 15%- Air changes (per hr): 10 times per hour- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycle
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- other: none
- Controls:
- yes
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Skin reactions of erythema and edema were scored 0.5, 24, 48 and 72 hours after removal of patch according to the method of Draize.
- Number of animals:
- 3
- Details on study design:
- None
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- erythema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 d.; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- (mean score 2)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- (mean score 3)
- Time point:
- other: overall at 24,48 and 72h
- Score:
- 0
- Irritation parameter:
- edema score
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: 0 d.; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- No reactions were observed in any rabbits during observation period.
- Other effects:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The irritation potential of the material was found to be 0, and therefore classified as non irritating.
- Executive summary:
The aim of this study was to determine the potential of FAT 40554 to induce irritation to rabbits skin. The study was carried out according to GLP methodology and OECD Guideline 404; 92/69/EEC, B.4.
One half of the test material was spread on the 1 inch square lint patch and applied to the intact skin of 3 rabbits with an occlusive tape for 4 hours.
At the end of exposure period, the patches were removed from the skin and the treated area was wiped to remove any remaining material by absorbent cotton dipped in acetone.
Skin reactions of erhthema and edema were scored 0.5, 24, 48 and 72 hours after removal of patch according to the method of Draize. The evaluation of irritation potency of the test material was performed by using primary irritation score.
No skin reactions such as erythema and edema were observed in any rabbits during the observation period. primary irritation score was 0. Therefore, the irritation potential of the material was judged to be negative.
According to the EEC classification of the results obtained 0.5 to 72 hours after removing the bandages FAT 40554 can be classified as non-irritant in albino rabbits.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Specific details on test material used for the study:
- None
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- None
- Vehicle:
- not specified
- Controls:
- other: other eye served as control
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- 3 days
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Duration of post- treatment incubation (in vitro):
- None
- Number of animals or in vitro replicates:
- 3 (2 males & 1 female)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing (if done): remain unwashed- Time after start of exposure: 1, 24, 48 and 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- (mean score 1)
- Time point:
- other: over all at 24,48 and 72 hours
- Score:
- 1
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- (means score 2)
- Time point:
- other: over all at 24,48 and 72 hours
- Score:
- 0.67
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- means score 3
- Time point:
- other: over all at 24,48 and 72 hours
- Score:
- 0.33
- Irritation parameter:
- conjunctivae score
- Max. score:
- 2
- Remarks on result:
- other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- other: over all at 24,48 and 72 hours
- Score:
- 0.33
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- other: over all at 24,48 and 72 hours
- Score:
- 0.33
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- other: over all at 24,48 and 72 hours
- Score:
- 0
- Irritation parameter:
- chemosis score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- other: overall at 24,48 and 72 hours
- Score:
- 0.67
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0.67
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean score 1
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0.33
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean score 2
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0.33
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean score 3
- Time point:
- other: overall at 24, 48 and 72 hours
- Score:
- 0
- Irritation parameter:
- iris score
- Max. score:
- 1
- Remarks on result:
- other: Max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 3 days.
- Other effects:
- None
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The irritation potential of the test material was judged to be mild, and therefore classified as non irritant.
- Executive summary:
The purpose of this study was to determine the eye irritating potency of FAT 40554
The study was performed according to GLP methodology and OECD guideline 405; 92/69/EEC, B.5.
3 rabbits were used to performed the test (1 males and 2 females). 100 mg of FAT 40554 was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The lids were then held together for about one second in order to prevent loss of the test article. The right eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality.
The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 40554 according to the OECD scoring system.
FAT 40554 is considered to be non-irritant to the eyes rabbits.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin:
The aim of this study was to determine the potential of FAT 40554 to induce irritation to rabbits skin. The study was carried out according to GLP methodology and OECD Guideline 404; 92/69/EEC, B.4.
One half of the test material was spread on the 1 inch square lint patch and applied to the intact skin of 3 rabbits with an occlusive tape for 4 hours.
At the end of exposure period, the patches were removed from the skin and the treated area was wiped to remove any remaining material by absorbent cotton dipped in acetone.
Skin reactions of erhthema and edema were scored 0.5, 24, 48 and 72 hours after removal of patch according to the method of Draize. The evaluation of irritation potency of the test material was performed by using primary irritation score.
No skin reactions such as erythema and edema were observed in any rabbits during the observation period. primary irritation score was 0. Therefore, the irritation potential of the material was judged to be negative.
According to the EEC classification of the results obtained 0.5 to 72 hours after removing the bandages FAT 40554 can be classified as non-irritant in albino rabbits.
Eye:
The purpose of this study was to determine the eye irritating potency of FAT 40554. The study was performed according to GLP methodology and OECD guideline 405; 92/69/EEC, B.5.
3 rabbits were used to performed the test (1 males and 2 females). 100 mg of FAT 40554 was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 40554 according to the OECD scoring system.
The test material induced slight congestion in iris, slight redness and very slight chemosis in conjuctiva in all rabbits one hour after application. At 24 hours after application, very slight opacity in cornea and slight to moderate redness in conjuctiva in all rabbits, very slight chemosis and moderate to severe discharge in conjuctiva in 2 rabbits.
These reactions disappeared in all rabbits after 72 hours of application. The maximum mean total of these irritation reactions calculated was 15.6 at 24 hours of post-application.
FAT 40554 is considered to be non-irritant to the eyes rabbits.
Justification for selection of skin irritation / corrosion endpoint:
Non GLP guideline study
Justification for selection of eye irritation 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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