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EC number: 271-351-7 | CAS number: 68541-71-9
- 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 317 is considered as non-irritant on skin and 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:
- 1994
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Test article: FAT 20011/D
Additional specification: Lanacron Marine S-G roh feucht
Batch No.: 61
Purity/Contents: CA. 52.5 %
Physical properties: solid
Storage conditions: room temperature
Validity: July 1999
Safety precautions: gloves and face masks
Test material received: March 22, 1994 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- The test was performed on 3 male rabbits, checked for normal skin conditions, weighing between 2190 to 2310 g. The animals were housed individually in metal cages, identified by ear tattoo, kept at a constant room temperature of 20+/-3 °C, at a relative humidity of 30-70 % and on a 12 hours light cycle day.
TEST ANIMALS
- Source: Chemisch-pharmazeutische Fabrik D-88397 Biberach
- Weight at study initiation: between 2190 to 2310 g
- Housing: The animals were housed individually in metal cages, identified by ear tattoo.
- Diet: The rabbits received ad libitum standard rabbit pellet - Nafag No. 814, Gossau, Switzerland - and fresh water.
- Water:ad libitum
- Acclimatisation period: at least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod: 12 hours light cycle day - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: A control gauze patch moistened with distilled water was applied to the contralateral flank.
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 3 days
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
An area of at least 36 cm² was shaved on both flanks of the animals approximately 24 hours before treatment. A gauze patch (approx. 12-16 cm²) bearing 0.5 g of the test article was applied to the right flank of each animal. The skin area exposed directly to the test article was approx. 6 cm². A control gauze patch moistened with distilled water was applied to the contralateral flank. The patches were loosely covered with an aluminum foil (approx. 36 cm²) and held in place for 4 hours by an adhesive tape (Isoplast, Isoplast AG, CH-5200 Brugg).
The animals were checked daily for systemic symptoms and mortality (only findings reported).
The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.
SCORING SYSTEM:
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 more than 1 mm):........................................................................ 3
- Severe edema (raised more than 1 mm and extending beyond area of exposure:................... 4
Total possible edema score 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Other effects:
- The body weight growth was not affected by the exposure.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20011/D is not irritating to the rabbit skin.
- Executive summary:
The aim of this study was to determine the potential of FAT 20011/D to cause irritation on skin. The study was carried out according to OECD Guideline 404 and EU Method B.4. An area of at least 36 cm² was shaved on both flanks of the three New Zealand rabbits. A gauze patch bearing 0.5 g of the test article was applied to the right flank of each animal. The skin area exposed directly to the test article was approx. 6 cm². A control gauze patch moistened with distilled water was applied to the contralateral flank. The patches were loosely covered with an aluminum foil and held in place for 4 hours by an adhesive tape. The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system. The mean score for erythema after 24/48/72 hrs was found to be 0.33 and the mean edema score was found to be 0. The skin reactions observed were reversible by 48 h observation. As the mean values of the recordings 24 to 72 hours after application were below the threshold of significance (2 score for erythema or edema) FAT 20011/D can be classified as non-irritant.
Reference
Overall results:
3 animals or less | Mean score animal 1* | Mean score animal 2* |
Mean score animal 3* |
Max value |
Maximum duration of any effect |
Max value at the end of the observation period |
Erythema/eschar | 0.33 | 0.33 | 0.33 | 1 | 24 hours | 0 |
Edema | 0 | 0 | 0 | 1 | 1 hour | 0 |
* Calculated on the basis of the scores at 24, 48 and 72 hours for each animal.
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:
- 1994
- 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
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- Test article: FAT20011/D
Additional specification: Lanacron Marine S-Grohfeucht
Batch No.: 61
Purity/Contents: CA.52.5%
Physical properties: Solid
Storage conditions: room temperature
Validity: July 1999
Safety precautions: gloves and face masks
Test material received: March22, 1994 - Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Chemisch-pharmazeutische Fabrik, D-88397 Biberach.
- Weight at study initiation: 1040-2340 g.
- Housing: Animalss were housed individually in metal cage, identified by ear tattoo.
- Diet : Rabbit food, NAFAG, N°. 814 Tox, NAFAG AG, Gossau, SG (Switzerland); ad libitum.
- Water: e.g. ad libitum.
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3.
- Humidity (%): 30-70.
- Photoperiod: 12 hours light/day. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 100 mg
- Duration of treatment / exposure:
- One application
- Observation period (in vivo):
- 7 days, because reactions were observed within 72 hours after instillation of the test article.
- Number of animals or in vitro replicates:
- 3 rabbits (1 male and 2 females)
- Details on study design:
- Application of the substance:
The test article was applied with a spatula. 100 mg of FAT 20011/D was placed into the conjunctival sac of the left 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 article. The right eye remained untreated and served as a control. The animals were checked daily for mortality. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 20011/D according to the OECD scoring system.
SCORING SYSTEM: Scale for scoring Ocular Lesions.
Cornea
Opacity-degree of density (area most dense taken for reading)
- No ulceration or opacity: 0
- Scattered or diffuse area of opacity , other than slight dulling of normal lustre), details of iris clearly visible: 1
- Easily discernible translucent areas, details of iris slightly obscured: 2
- Nacrous area, no details of iris visible, size of pupil barely discernible: 3
- Opaque cornea, iris not discernible through the opacity: 4
Iris
- Normal: 0
- Markedly deepended rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any 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
Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae excluding cornea and iris)
- Blood vessels normal: 0
- Some blood vessels definitely : 1
- Diffuse, crimson colour, individual vessels not easily discernible: 2
- Diffuse beefy red: 3
Chemosis
Lids and or nictating membrane
- 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 more than half closed: 4 - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 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:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 20011/D is considered to be non-irritant to the eyes rabbits.
- Executive summary:
The purpose of this study was to determine the eye irritating potency of FAT 20011/D. The study was performed according to OECD Guideline 405 and EU Method B.5, in compliance with GLP. 3 rabbits were used to performed the test (1 males and 2 females). 100 mg of FAT 20011/D was placed into the conjunctival sac of the left 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 article. The right eye remained untreated and served as a control. The animals were checked daily for systemic symptoms and mortality. The ocular reactions were evaluated 1, 24, 48, and 72 hours after the instillation of FAT 20011/D according to the OECD scoring system. Mild irritation reactions were seen with iris and conjunctiva, which were mostly reversible within 7 days. Hence, FAT 20011/C is considered to be non-irritant to the eyes rabbits.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin
The potential of FAT 20011/D to cause irritation on skin was assessed in a study carried out according to OECD Guideline 404 and EU Method B.4. The mean score for erythema after 24/48/72 h was found to be 0.33 and the mean edema score was found to be 0. The skin reactions observed were reversible by 48 h observation. As the mean values of the recordings 24 to 72 hours after application were below the threshold of significance (2 score for erythema or edema) FAT 20011/D can be classified as non-irritant.
The
two supporting studies were carried out with FAT 20011/C and FAT 20011/A also
support the conclusion that Acid Blue 317 is not irritating to the skin
as per the criteria laid out by the regulation (EC) No. 1272/2008.
Eye:
The purpose of this study was to determine the eye irritating potency of FAT 20011/D. The study was performed according to OECD Guideline 405 and EU Method B.5, in compliance with GLP. 3 rabbits were used to performed the test (1 males and 2 females). 100 mg of FAT 20011/D was placed into the conjunctival sac of the left eye of each animal, after gently pulling away the lower lid from the eyeball. Mild irritation reactions were seen with iris and conjunctiva, which were mostly reversible within 7 days. Hence, FAT 20011/C is considered to be non-irritant to the eye in rabbits.
The conclusion that Acid Blue 317 is not irritating to the eyes was further supported by negative outcome from the eye irritation studies with FAT 20011/C and 20011/A conducted in 1982 and 1974 respectively.
Justification for classification or non-classification
The Acid Blue 317 is considered as non-irritant to skin and eye, hence it does not warrant classification as per the 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.
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