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EC number: 289-530-3 | CAS number: 89899-25-2
- 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 20290/A is found to be a non-irritant to skin and eyes.
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:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: United States Environmental Protection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritaion study", Federal Register, Vol 43 No. 163, August 22, 1978.
- Deviations:
- not specified
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- 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
- Weight at study initiation: 2-3 kgs
- Housing: Caged individually
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland); ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 55±15 %
- Photoperiod: Animals were exposed to artificial light for 12 hours light/day
- Air changes: 15 air changes/h - Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved as well as abraded
- Vehicle:
- not specified
- Controls:
- not specified
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 d
- Number of animals:
- six (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 with the help of a "Schroepfschnaepper", Aesculap, Switzerland. Gauze patches of 2.5 x 2.5 cm soaked with 0.5 ml of
the test material were applied to the prepared abraded and intact skin.
- The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after 24 hours. The skin reaction was assessed upon removal and during a subsequent observation period of 7 days. - Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- (intact skin)
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Remarks:
- (abraded skin)
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- erythema score
- Remarks:
- (abraded skin)
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- erythema score
- Remarks:
- (abraded skin)
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- erythema score
- Remarks:
- (abraded skin)
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Remarks:
- (abraded skin)
- Basis:
- animal #5
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- erythema score
- Remarks:
- (abraded skin)
- Basis:
- animal #6
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- (intact skin)
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Remarks:
- (abraded skin)
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- edema score
- Remarks:
- (abraded skin)
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- edema score
- Remarks:
- (abraded skin)
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7d
- Irritation parameter:
- edema score
- Remarks:
- (abraded skin)
- Basis:
- animal #4
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- edema score
- Remarks:
- (abraded skin)
- Basis:
- animal #5
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- edema score
- Remarks:
- (abraded skin)
- Basis:
- animal #6
- Remarks:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritant / corrosive response data:
- FAT 20290/A was found to cause slight irritation when applied to intact and abraded rabbit skin.
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20290/A can be regarded as not irritating to rabbit skin.
- Executive summary:
An in vivo study was conducted to evaluate the skin irritation potential of the test substance in rabbits according to the Guidelines of the United States Environmental Protection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43 No. 163, and August 22, 1978. Gauze patches of 2.5 x 2.5 cm soaked with 0.5 ml of the test material were applied to abraded and intact skin of 6 rabbits. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after 24 hours. The skin reaction was assessed upon removal and during a subsequent observation period of 7 days. FAT 20290/A was found to cause slight irritation when applied to intact and abraded rabbit skin. However, the scores recorded were below the threshold scores required for classification as recommended by Regulation (EC) No. 1272/2008. Hence, FAT 20290/A can be regarded as not irritating to rabbit skin.
Reference
FAT 20290/A was found to cause slight irritation when applied to intact and abraded rabbit skin. The scores read after 24 and 72 hours for erythema and edema for the intact as well for the abraded skin was were summed up and divided by 4 (FHSLA paragraph 191.11). Primary irritation index of 1.9 was recorded. But it can be noted that abrasion on skin causes epidermal injury and further expected to cause the skin irritation and adverse effects to epidermis. This reaction could be referred to the damage caused due to abrasion rather than due to the test substance application. In general abrasion is an elevated testing condition and results normally do not have to be taken into account for hazard assessment. Hence, The test substance FAT 20290/A can be regarded as not irritating to rabbit skin.
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:
- 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study" Federal Register, Vol. 43, No. 163, August 22, 1978.
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- After checking for normal ophthalmic conditions
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Age at study initiation: 3 to 4 months
- Weight at study initiation: Males: 2- 3 kgs
- Housing: Caged singly
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAGAG/ Gossau, SG (Switzerland), ad libitum
- Water: ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3 °C
- Humidity: 55±15%
- Photoperiod: Animals were exposed to artificial light for 12 hours light/day
- Air changes: 15 air changes/h - Vehicle:
- not specified
- Controls:
- other: untreated right eye
- Amount / concentration applied:
- - Amount(s) applied: 0.1 ml
- Duration of treatment / exposure:
- Unwashed eye: unspecified (not rinsed after single instillation)
Washed eye: 30 sec - Observation period (in vivo):
- 7d
- Number of animals or in vitro replicates:
- Six rabbits (three males and three females)
- Details on study design:
- PROCEDURE:
-The procedure used is based but not in every part identical with the Proposed Guidelines of the United States Environmental Protection Agency (EPA)
Paragraph 163.81-5 "Primary eye irritation study"r Federal Register, Vol. 43 No. 163 August 22, 1978.
- The test material in an amount of 0.1 ml was inserted in the conjunctival sac of the left eye of the rabbits and the lids were gently closed for 15 seconds. The right eye was not treated and served as an untreated control.
- The eye irritation was assessed with a slit-lamp at 24, 48, 72 hours and 4 and 7 days after treatment
REMOVAL OF TEST SUBSTANCE
In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline.
REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:
SCORING SYSTEM:
Cornea
A. Opacity and degree of density (area most dense taken for reading)
No opacity 0
Scattered or diffuse areas, 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 Maximum possible score = 80
Iris
A. Values
Normal 0
Folds above normal, congestion, swelling, circumcornea 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
A x 5 Maximum possible score = 10
Conjunctivae
A. Redness (refers to palpebral and bulbar conjunctivae, excluding cornea and iris)
Blood 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 Maximum possible score = 20 - 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
- Remarks:
- (redness)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of abnormal reaction was seen in any animals after application of the test substance. Hence the primary irritation index was 0.
- Other effects:
- No abnormalities reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20290/A was considered to be not an eye irritant.
- Executive summary:
A study was conducted to assess the eye irritancy potential of the test substance in rabbits according to United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study Federal Register, Vol. 43 No. 163 August 22, 1978.
The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for 15 seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline. The eye irritation was assessed with a slit-lamp at 24, 48, 72 hours and 4 and 7 days after treatment.
No signs of abnormal reaction were seen in any animals after application of the test substance. Hence the primary irritation index was 0. Hence, based on the findings of the study, FAT 20290/A was not an eye irritant.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation:
The skin irritation potential of Acid Blue 314 (FAT 20290/A) was evaluated in a study conducted according to the Guidelines of the United States Environmental Protection Agency (EPA), Paragraph 163.81-5 "Primary dermal irritation study", Federal Register, Vol. 43 No. 163, and August 22, 1978. Gauze patches of 2.5 x 2.5 cm soaked with 0.5 ml of the test material were applied to abraded and intact skin of 6 rabbits. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after 24 hours. The skin reaction was assessed upon removal and during a subsequent observation period of 7 days. FAT 20290/A was found to cause slight irritation when applied to intact and abraded rabbit skin. However, the scores recorded were below the threshold scores required for classification as recommended by Regulation (EC) No. 1272/2008. Hence, FAT 20290/A can be regarded as not irritating to rabbit skin.
Eye irritation:
The eye irritancy potential of Acid Blue 314 (FAT 20290/A) was evaluated in a study conducted according to United States Environmental Protection Agency (EPA) Paragraph 163.81-5 "Primary eye irritation study Federal Register, Vol. 43 No. 163 August 22, 1978. The test material in an amount of 0.1 ml was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for 15 seconds. The right eye was not treated and served as an untreated control. In 3 of the 6 rabbits approximately 30 seconds after the treatment the treated eye was flushed with 10 ml of sterile physiological saline. The eye irritation was assessed with a slit-lamp at 24, 48, 72 hours and 4 and 7 days after treatment. No signs of abnormal reaction were seen in any animals after application of the test substance. Hence the primary irritation index was 0. Hence, based on the findings of the study, FAT 20290/A was not an eye irritant.
Taking into consideration data from both skin and eye irritation/corrosion studies, it can be concluded that the test substance FAT 20290 is non-irritating to skin and eye.
Justification for classification or non-classification
Based on the finding in the skin and eye irritation studies, Acid Blue 314 does not need to be classified according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.