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EC number: 264-129-6 | CAS number: 63405-85-6
- 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 20004 is considered to be non irritant to eyes and skin of rabbits.
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:
- Study completion date - 14 August 1978.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
- Deviations:
- not specified
- GLP compliance:
- no
- Specific details on test material used for the study:
- Name: FAT 20004/D
Purity: 61 % - Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs
- Housing: Housed individually in metal cages
- Diet: NAFAG Gossau SG
- Water: water ad libitum
- Acclimation period: minimum of 4 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1°C
- Humidity: 55 ± 5 %
- Photoperiod: 10 hours light cycle day - Type of coverage:
- occlusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g - Duration of treatment / exposure:
- 24 h
- Observation period:
- Up to 7 d
- Number of animals:
- six animals (Three males and three females)
- Details on study design:
- TEST SITE
- Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified. Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test material were applied to the prepared abraded and intact skin.
Score for skin irritation in rabbits
Erythema and eschar formation
No erythema............................................................ 0
Very slight erythema (barely perceptible).................... 1
Well defined erythema.............................................. 2
Moderate to severe erythema.................................... 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) ........4
Total possible erythema score 4
Edema formation
No edema................................................................ 0
Very slight edema (barely perceptible)........................ 1
Slight edema (edges of area well defined by definite raising)..... 2
Moderate edema (raised approximately 1 mm)........................ 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) ........4 - Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal:
- Remarks:
- mean of six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- Abraded skin
- Basis:
- animal:
- Remarks:
- mean of six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- animal:
- Remarks:
- mean of six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- Abraded skin
- Basis:
- animal:
- Remarks:
- mean of six animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20004/D was found to cause no irritation when applied to intact and abraded rabbit skin.
- Executive summary:
A key in vivo study was conducted to evaluate the skin irritation potential of the test substance in rabbits according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test preparation were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24-hours exposure. The mean 24/48/72 h score for edema and erythema was zero at all time points. Under the conditions of the present experiment FAT 20004/D was found to cause no irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 0.
Reference
Calculation of the primary skin irritation index:
The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4.
Time after exposure h | mean reaction score of 6 rabbits | ||||
erythema | edema | ||||
intact skin | abraded skin | intact skin | abraded skin | ||
24 | 0 | 0 | 0 | 0 | |
72 | 0 | 0 | 0 | 0 | |
subtotal | 0 | 0 | 0 | 0 | |
total | 0 + 0 + 0 + 0 = 0 |
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:
- Study completion date - 14 August 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
- GLP compliance:
- no
- Specific details on test material used for the study:
- Name: FAT 20004/D
Purity: 61 % - Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs
- Housing: Housed individually in metal cages
- Diet: NAFAG, Gossau SG ad libitum
- Water: Water, ad libitum
- Acclimation period: 4 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 1 °C
- Humidity: 55 ± 5 %
- Photoperiod: 10 hour light cycle - Vehicle:
- not specified
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- - Amount(s) applied: 100 mg
- Duration of treatment / exposure:
- Unwashed eye: unspecified (not rinsed after single instillation)
Washed eye: 30 sec - Observation period (in vivo):
- The rabbits were examined for day 1, 2, 3, 4 and 7 d after application of the test.
- Number of animals or in vitro replicates:
- Six animals (Three males and three females)
- Details on study design:
- PROCEDURE:
The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the 6 rabbits and the lids were gently closed for one second. The right eye was not treated and served as an untreated control.
REMOVAL OF TEST SUBSTANCE: In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water.
SCORING SYSTEM: The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. The primary eye irritation index represents the sum of the mean values for cornea, iris and conjunctivae. This procedure was carried out separately for unrinsed and rinsed eyes, respectively.
SCORING SYSTEM: Scale for scoring Ocular Lesions.
1.Cornea
(A) Opacity-degree of density (area most dense taken for reading)
- No opacity: 0
- Scattered or diffuse area, details of iris clearly visible: 1
- Easily discernible translucent areas, details of iris slightly obscured: 2
- Opalescent areas, no details of iris visible, size of pupil barely discernible: 3
- Opaque, iris invisible: 4
(B) Area of cornea involved
- One quarter (or less) but not zero: 1
- Greater than one quarter but less than half: 2
- Greater than half, but less than three quarters: 3
- Greater than three quarters, up to whole area: 4
AxBx5 Total maximum=80
2.Iris
(A) Values
- Normal: 0
- Folds above normal, congestion, swelling, circumcorneal injection (any or all of these or combination of any thereof) iris still reacting to light (sluggish reaction is positive): 1
- No reaction to light, haemorrhage, gross destruction (any or all of these): 2
Ax5 Total maximum=10
3.Conjunctivae
(A) Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
- Vessels normal: 0
- Vessels definitely injected above normal: 1
- More diffuse, deeper crimson red, individual vessels not easily discernible: 2
- Diffuse beefy red: 3
(B) Chemosis
- No swelling: 0
- Any swelling above normal (includes nictitating membrane): 1
- Obvious swelling with partial eversion of lids: 2
- Swelling with lids about half closed: 3
- Swelling with lids about half closed to completely closed: 4
(C) Discharge'
- No discharge: 0
- Any amount different from normal (does not include small amounts observed" in inner canthus of normal animals): 1
- Discharge with moistening of the lids and hairs just adjacent to lids: 2
- Discharge with moistening of the lids and hairs, and considerable area around the eye: 3
Score (a+b+c)x 2 Total maximum=20
TOOL USED TO ASSESS SCORE: slit lamp - Irritation parameter:
- cornea opacity score
- Remarks:
- Rinsed eyes
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- Rinsed eyes
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Rinsed eyes
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Rinsed eyes
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- Not rinsed eyes
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Remarks:
- Not rinsed eyes
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Not rinsed eyes
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 3
- Reversibility:
- fully reversible within: 96 h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Remarks:
- Not rinsed eyes
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 96 h
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the study conditions, the test substance was considered to be an non-irritant to rabbit eyes.
- Executive summary:
A study was conducted to assess the eye irritancy potential of the test substance in rabbits according to procedure "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the six rabbits. The eyelids were then held closed for 1 second. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. In the present experiments the cornea, iris and conjunctivae scores were zero for rinsed eyes. Therefore, the test material was considered to be a non-irritant to rabbit eyes.
Reference
Unrinsed Eyes | Rinsed Eyes | |||||||||||||||||
Days after Appl. | Rabbit 1 (Male) | Rabbit 2 (Male) | Rabbit 3 (Male) | Rabbit 4 (Female) | Rabbit 5 (Female) | Rabbit 6 (Female) | ||||||||||||
Cornea | Iris | Conjuctiva | Cornea | Iris | Conjuctiva | Cornea | Iris | Conjuctiva | Cornea | Iris | Conjuctiva | Cornea | Iris | Conjuctiva | Cornea | Iris | Conjuctiva | |
1 | 0 | 0 | 12 | 10 | 0 | 12 | 10 | 0 | 12 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
2 | 0 | 0 | 6 | 10 | 0 | 10 | 10 | 0 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
3 | 0 | 0 | 6 | 5 | 0 | 8 | 5 | 0 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
5 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
7 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Cornea: 3.3 | Iris: 0 | Conjuctivae: 5.3 | Cornea: 0 | Iris: 0 | Conjuctivae: 0 |
effect of rinsing R = unrinsed eyes 2.9
rinsed eyes 0
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin Irritation:
A key in vivo study was conducted to evaluate the skin irritation potential of the test substance in rabbits according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). Gauze patches of 2.5 x 2.5 cm laden with 0.5 g of the test preparation were applied to the prepared abraded and intact skin. The patches were covered with an impermeable material and fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour exposure. The mean 24/48/72 h score for edema and erythema was zero at all time points. Under the conditions of the present experiment FAT 20004/D was found to cause no irritation when applied to intact and abraded rabbit skin. The calculated primary irritation index was 0. In other supporting studies, FAT 20004 was found to be not irritating to the skin.
Eye Irritation:
A study was conducted to assess the eye irritancy potential of the test substance in rabbits according to procedure "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO). The test material in an amount of 0.1 g was inserted into the conjunctival sac of the left eye of the six rabbits. The eyelids were then held closed for 1 second. In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of lukewarm water. The eye irritation was appraised with a slit-lamp on day 1, 2, 3, 4 and 7 and was scored for each individual rabbit. In the present experiments the irritation index was established as 1.7 for the cornea, 0 for the iris and 2.6 for the conjunctivae. The test material caused therefore a minimal overall eye irritation to rabbits. In other supporting studies, FAT 20004 was found to be not irritating to eyes.
Justification for classification or non-classification
Based on the above stated assessment of the skin irritation potential, the substance does not have to be classified for skin irritation according to CLP (Regulation (EC) No 1272/2008 Of the European parliament and of the Council.
Base on the above assessment of the eye irritation potential, the substance does not have to be classified as for risk of serious damage to eyes according to CLP (Regulation (EC) No 1272/2008 Of the European parliament and of the Council.
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