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EC number: 279-365-5 | CAS number: 80010-51-1
- 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
Acid Blue 225 is to be considered as not irritating to the skin as well as to the 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:
- 04 June 1974
- 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) 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:
- Name: 21036 / A
Purity: 79.9 % - Species:
- rabbit
- Strain:
- other: Russian Breed
- Details on test animals or test system and environmental conditions:
- Six rabbits (3 males/3 females) of the Russian breed, weighing 1.5 to 2 kgs, were shaved on the whole back and flanks two days before treatment with an electric clipper. In order to prevent injuries by bites the rabbits were kept separately in V2A wire cages, where they had access to food (NAFAG, Gossau SG, rabbit food) and water ad libitum. 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 coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- other: 50 % polyethylene glycol trituration (PEG 400)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- FAT 21036/A was applied to each side in quantities of 0.5 g.
- Duration of treatment / exposure:
- The gauze patches were removed 24 hours after the application.
- Observation period:
- The reaction of the skin was appraised upon removal and 72 hours after it.
- Number of animals:
- 3 males and 3 females
- Details on study design:
- FAT 21036/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.
Evaluation of Skin Reactions
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
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:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Remarks:
- scarified skin
- Basis:
- mean
- Remarks:
- 6 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:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Remarks:
- scarified skin
- Basis:
- mean
- Remarks:
- 6 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 21036/A was found to be not irritating to the rabbit skin.
- Executive summary:
A study was performed to determine the skin irritation potential of FAT 21036/A on Russian breed rabbits according to "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) weighing 1.5 to 2 kgs, were shaved on the whole back and flanks two days before treatment with an electric clipper. In order to prevent injuries by bites the rabbits were kept separately in V2A wire cages, where they had access to food (NAFAG, Gossau SG, rabbit food) and water ad libitum. 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 21036/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. No erythema or edema was observed in the study. All scores were zero. Hence, the primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0. Therefore, FAT 21036/A is to be considered as not irritating 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:
- 1974
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (1959) of the US Association of Food and Drug Officials (AFDO).
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- Name: 21036 / A
Purity: 79.9% - Species:
- rabbit
- Strain:
- other: Russian Breed
- Details on test animals or tissues and environmental conditions:
- The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed, which were kept separately in V2A wire cages and fed on NAFAG, Gossau SG, rabbit food and water ad libitum. Only rabbits showing normal ophthalmic findings were included in the test.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- Amounts of 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the 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.
- Observation period (in vivo):
- 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" (1959) of the AFDO.
- Number of animals or in vitro replicates:
- 6 rabbits (3 males/3 females)
- Details on study design:
- SCORING SYSTEM:
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
Iris
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
Conjunctivae
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
Chemosis
No swelling...............................................................................................................................0
Any swelling above normal (includes nictitating membrane)...........................................................1
Obvious swelling with partial eversion of lids Swelling with lids about half closed..............................2
Swelling with lids about half closed to completely closed...............................................................3
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
TOOL USED TO ASSESS SCORE: hand-slit lamp - Irritation parameter:
- cornea opacity score
- 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
- 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
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 21036/A is to be considered as a non-irritant to the eye of rabbits.
- Executive summary:
A key study was performed to determine the eye irritation potential of FAT 21036/A in rabbits. The procedure adopted was the 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). The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed. 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the 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. Cornea and Iris scores were zero at all time intervals. slight conjuctival irritation was observed in two rabbits which were reversible within 48 h. The irritation index was found to be 5.8 for the cornea, 0 the iris and 5 for the conjunctivae. According to the EC classification of the results obtained, FAT 21036/A can be classified as non irritant to albino rabbit's eye.
Reference
Table: Scores when eyes were not rinsed
Days after application |
Rabbit 4 |
Rabbit 5 |
Rabbit 6 |
||||||
Cornea |
iris |
Conjunctiva |
Cornea |
iris |
Conjunctiva |
Cornea |
iris |
Conjunctiva |
|
1 |
20 |
0 |
12 |
15 |
0 |
12 |
15 |
0 |
12 |
2 |
20 |
0 |
10 |
10 |
0 |
10 |
15 |
0 |
10 |
3 |
15 |
0 |
10 |
10 |
0 |
10 |
10 |
0 |
10 |
4 |
5 |
0 |
8 |
10 |
0 |
8 |
10 |
0 |
6 |
7 |
5 |
0 |
6 |
5 |
0 |
8 |
10 |
0 |
6 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin:
The skin irritation potential of FAT 21036/A was assessed in a study conducted according to "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Six Russian breed rabbits were exposed to 0.5 g FAT 21036/A each on shaved as well as scarified skin. No erythema or edema was reported throughout the study. The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0. Therefore FAT 21036/A is to be considered as not irritating to the skin of rabbits.
Eye:
A key study was performed to determine the eye irritation potential of FAT 21036/A in rabbits. The procedure adopted was the 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). The substance was tested on 6 rabbits (3 males/3 females) of the Russian breed. 0.1 g of the test substance were introduced into the conjunctival sac of the left eye with a spatula. After application, the 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. Cornea and Iris scores were zero at all time intervals. slight conjuctival irritation was observed in two rabbits which were reversible within 48 h. The irritation index was found to be 5.8 for the cornea, 0 the iris and 5 for the conjunctivae. According to the EC classification of the results obtained, FAT 21036/A can be classified as non irritant to albino rabbit's eye.
Justification for classification or non-classification
Based on the above stated assessment, Acid Blue 225 is to be considered as a non-irritant to the skin as well as to eye of rabbits according to CLP (Regulation (EC) No. 1272/2008 Of the European Parliament and of the Council.
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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