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EC number: 258-027-0 | CAS number: 52587-68-5
- 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 21095/A is considered to be non- irritant to skin and eye 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:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
- Deviations:
- yes
- Remarks:
- Testing under occluvive conditions represents an elevated testing condition and results obtained under such conditions need to be carefully taken ito account for the overall hazard and risk assessment.
- Principles of method if other than guideline:
- The purpose of this test was to determine the primary-irritation index, which serves as a measure of the acute irritation,provoked by the compound on the skin of the rabbits.
- GLP compliance:
- no
- Specific details on test material used for the study:
- Identification: FAT 21095/A
Purity: 80 % - Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs.
- Housing: In order to prevent injuries by bites the rabbits were kept separately in V2A wire mesh cages.
- Diet and water: they had access to food (NAFAG, Gossau SG, rabbit food) and water ad libitum. - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: Polyethylene glycol trituration (PEG 400)
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 rabbits (3 males and 3 females)
- Details on study design:
- The rabbits were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.
FAT 21095/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it, on the basis of the following evaluation scheme.
SCORING SYSTEM:
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
Total possible edema score 4
TEST SITE
- Area of exposure: The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape.
- Type of wrap if used: plastic film
- Time after start of exposure: 72 hours - Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #1
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #2
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #3
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #4
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #5
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #5
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #5
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #6
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #6
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- erythema score
- Remarks:
- Intact skin
- Basis:
- animal #6
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 48 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- edema score
- Remarks:
- Intact skin
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Compounds producing combined averages (primary irritation indexes) of 2 or less are only mildly irritating; whereas those with indexes from 2 to 5 are moderate irritants, and those with scores above 6 are considered severe irritants.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.29. Therefore, FAT 21095/A is to be considered as a non-irritant irritant to the skin of rabbits.
- Executive summary:
The purpose of this test was to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound on the skin of the rabbits. The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Six rabbits (3 males/3 females) of the Russian breed, were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch was soaked with the test substance FAT 21095/A (0.5 g) and immediately applied to the prepared skin. The patch was covered with a plastic film (occlusive). FAT 21095/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 2 4 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. Slight erythema was observed in Intact and abraded skin which was reversible within 72 hours. No edema was observed at any observation time points. The primary irritation index as the measure of the acute irritation to the skin of rabbits was determined to be 0.29. Therefore, FAT 21095/A is to be considered as non-irritant to the skin of rabbits.
Reference
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:
- 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: The procedure adopted was the technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetic (1959) of the US Association of Food and Drug Officials (AFDO).
- Deviations:
- not specified
- GLP compliance:
- no
- Specific details on test material used for the study:
- Identification:21095/A
Purity: 80 % - Species:
- rabbit
- Strain:
- other: Russian breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: Rabbits were kept separately in V2A wire-mesh cages
- Diet (e.g. ad libitum):Rabbits were fed on NAFAG, Gossau SG, rabbit food
- Water (e.g. ad libitum): ad libitum - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Yes, right eye of rabbit served as control.
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 30 seconds
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 rabbits (3 males and 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment.
- Time after start of exposure: 24 hours
SCORING SYSTEM:
Evaluation of the Eye Reactions
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
A x B x 5 Total maximum = 80
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, hemorrhage, gross destruction (any or all of these): 2
Ax5
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
(A + B + C) x 2 Total maximum =20
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Eyes rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Eyes rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.11
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Eyes rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.88
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Eyes rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: Eyes not rinsed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.89
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Eyes not rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Eyes not rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 1.78
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Eyes not rinsed
- Irritant / corrosive response data:
- The total maximum is 80 for the cornea, 10 for the iris and 20 for the conjunctivae.
The irritation index was found to be 7.8 for the cornea, 0 for the iris and 5.8 for the conjunctivae. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 21095/A is considered to be not irritating to rabbit eyes.
- Executive summary:
FAT 21095/A was tested for eye irritation potential on rabbits eye. This test was conducted in accordance with "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the AFDO. The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed. Only rabbits showing normal ophthalmic findings were included in the test. Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, they eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days. In rinsed eyes, effects were observed on conjuctivae and cornea which were reversible within 7 days. Similar effects were observed in unrinsed eyes which were not reversible within 7 days. No effect on Iris was observed in both rinsed and unrinsed eye. Based on the findings of the study, FAT 21095/A is considered to be not irritating to rabbit eyes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A study was conducted to assess the potential of FAT 21095/A to cause acute irritation on the rabbit skin. The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Six rabbits (3 males/3 females) of the Russian breed were used in the occlusive patch test. FAT 21095/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.29. It is necessary to note that testing under occlusive conditions represents an elevated testing condition compared to OECD guideline. Nevertheless, no signs of irritation have been noted. Therefore, the test is regarded to be valid for assessment. Hence, FAT 21095/A is to be considered as non-irritant to the skin of rabbits.
To assess the acute eye irritation potential of FAT 21095/A when exposed to rabbit eye, a study was performed in accordance to the procedure mentioned in "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (19 59) of the AFDO.
The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed. Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, they eyelids were held open for a few seconds. The right eye served as a control. The treated eyes of three rabbits were each rinsed with 10 ml lukewarm water about 30 seconds after treatment. The reactions were appraised with a slit-lamp after 24 hours and after 2, 3, 4 and 7 days on the basis of the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (19 59) of the AFDO. The primary-irritation index, which serves as a measure of the acute irritation provoked by the substance, was found to be 7.8 for the cornea, 0 for the iris and 5.8 for the conjunctivae. Therefore, FAT 21095/A is to be considered to be non-irritant to rabbit eyes.
Justification for selection of skin
irritation / corrosion endpoint: Basic data given, acceptable for
assessment
Justification for selection of eye irritation endpoint: Basic
data given, acceptable for assessment
Justification for classification or non-classification
FAT 21095/A is considered to be non-irritant to skin and eye of rabbits. Considering that the reaction in the eye to be fully reversible, FAT 21095/A is classified as non-irritant in eye.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.