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EC number: 291-174-9 | CAS number: 90342-37-3
- 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
Skin irritation:
In the study considered to be key, the skin irritation potential of FAT 45082/D was evaluated according to OECD Guideline 404. In this study, FAT 45082/D with 54.6% purity was tested on rabbit’s skin. Under the experimental conditions employed FAT 45082/D induced erythema and edema reactions when applied to the clipped albino rabbit skin. However, the mean values of the recordings 24 to 72 hours after application are under the threshold of significance. Hence, FAT 45082/D can be classified as non-irritant according to the EEC directive No. 83/467/1983.
In a supporting study, FAT 45082/E with 28.7 % purity induced slight erythema reactions when applied to the clipped albino rabbit skin. The reactions were observed only one hour after removing the bandages.The mean values of the recordings 24 to 72 hours after application were scored to be zero. Hence, FAT 45082/E can be classified as non-irritant according to the EEC directive No. 83/467/1983.
Another supporting study with FAT 45082/B (purity: not known) was found to cause a minimal irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 0.7. The mean reaction scores for intact skin were too low as compared to abraded skin.
Considering the results from the key and supporting studies it can be concluded that, FAT 45082 is non-irritating to rabbit’s skin.
Eye irritation:
The study considered to be key was performed to evaluate the eye irritation potential of FAT 45082/D. The test item FAT 45082/D with 54.6 % purity was tested on rabbit’s eye. Under the experimental conditions employed FAT 45082/D did not induce eye irritation when applied into the conjunctival sac of albino rabbits. According to the EEC directive No.83/467/1983 FAT 45082/D can, therefore, be classified as non-irritant.
In a supporting study, the test item FAT 45082/E with 28.7 % purity induced irritation of the cornea and conjunctiva when applied into the conjunctival sac of albino rabbits. The mean values of the readings 24 to 72 hours after application were below the threshold of significance. Hence, FAT 45082/E can be classified as non-irritant according to the EEC directive No.83/467/1983.
Under the conditions of another supporting experiment the test material FAT 45082/B (purity unknown) was found to cause a minimal irritation when applied to the rabbit eye mucosa. The primary irritation index was found to be: unrinsed eyes = 0.5; rinsed eyes = 0.4 . However, the reactions were reversible after 7 days of observation in both rinsed and unrinsed eyes. Hence substance is not expected to be eye irritant and can be concluded as non-irritant.
Considering the data from the key and supporting studies it can be concluded that FAT 45082 is non-irritating to rabbit’s 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:
- 19 February, 1985 to 22 March, 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- Test substance: FAT 45082/D
Batch No.: EN 35713.42
Physical properties: powder; dispersible in water; pH: 8.5 (1 g/L water)
Validity: June 1989
Safety precautions: gloves and face masks
Test material received: February 11, 1985 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: approx. 12-14 weeks old
- Weight at study initiation: 2 to 3 kg
- Housing: The animals were housed individually in metal cages, identified with individually numbered ear tags
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day
IN LIFE PHASE- From: 19 February, 1985; To: 26 February, 1985 - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: at least 6 cm²
- Type of wrap if used: The patches were loosely covered with an aluminum foil (36 cm²)
SCORING SYSTEM:
The irritant / corrosive potency of FAT 45'082/D was classified according to the EEC commission directive No. 83/467/1983 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.78
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.56
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- None
- Other effects:
- Body weight gain was normal during the experimental period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 45'082/D can be classified as non irritant according to the EEC directive No. 83/467/1983.
- Executive summary:
The skin irritation potential of FAT 45082/D was evaluated in a study conducted according to OECD Guideline 404. 3 male rabbits were used for this purpose. Under the experimental conditions employed, FAT 45082/D induced erythema and edema reactions when applied to the clipped albino rabbit skin. The mean scores for erythema and edema were 0.78 and 0.56, respectively. Because the mean values of the scores at 24 to 72 hours after application were under the threshold of significance, FAT 45082/D can be classified as non-irritant according to the EEC directive No. 83/467/1983.
Reference
Scoring tables
Erythema | ||||||
Animal | 1 hour | 24 hours | 48 hours | 72 hours | 7 days | |
69 | 2 | 2 | 2 | 1 | 0 | |
70 | 2 | 1 | 1 | 0 | 0 | |
71 | 1 | 0 | 0 | 0 | 0 | |
Total | 5 | 3 | 3 | 1 | ||
1.67 | 1.00 | 1.00 | 0.33 |
Edema | ||||||
Animal | 1 hour | 24 hours | 48 hours | 72 hours | 7 days | |
69 | 1 | 2 | 1 | 0 | 0 | |
70 | 1 | 1 | 1 | 0 | 0 | |
71 | 1 | 0 | 0 | 0 | 0 | |
Total | 3 | 3 | 2 | 0 | ||
1.00 | 1.00 | 0.67 | 0.00 |
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:
- 05 March, 1985 to 27 March, 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- Test substance: FAT 45082/D
Batch No.: EN 35713.42
Physical properties: powder; dispersible in water; pH: 8.5 (1 g/L water)
Validity: June 1989
Safety precautions: gloves and face masks
Test material received: February 11, 1985 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Maedorin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 12-14 weeks old
- Weight at study initiation: 2 to 3 kg
- Housing: The animals were housed individually in metal cages, identified with individually numbered ear tags.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 30-70
- Photoperiod: 12 hours light cycle day
IN LIFE PHASE: From: 05 March, 1985; To: 08 March, 1985 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- 0.1 g of FAT 45082/D was placed into the conjunctival sac of the right 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 material. The left eye remained untreated and served as a control. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 45082/D.
SCORING SYSTEM: according to the OECD scoring system
TOOL USED TO ASSESS SCORE: A slit-lamp - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 h
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 h
- Irritant / corrosive response data:
- None
- Other effects:
- No effect on body weight gains was seen.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 45082/D has no primary eye irritation potency in albino rabbits.
- Executive summary:
The eye irritation potential of FAT 45082/D was evaluated in a study conducted according to OECD Guideline 405. 0.1 g of FAT 45082/D was placed into the conjunctival sac of the right eye of each of 3 male rabbits, 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 material. The left eye remained untreated and served as a control. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 45082/D. Slight conjunctival redness and chemosis were reported at 1 hour observation, which was found to have reversed by 24 hours. Because no reactions were observed at 72 hours after instillation of FAT 45082/D, the test was ended after the 72 hours evauation. Based on these findings, it can be concluded, that FAT 45082/D has no primary eye irritation potency in albino rabbits.
Reference
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
FAT 45082 is found to be non-irritating to rabbit skin and eyes, hence it does not warrant classification according to the criteria of Regulation (EC) No. 1272/2008 (CLP).
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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