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EC number: 916-918-8 | CAS number: -
- 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
The substance was found to be non-irritating to skin (OECD 404).
The substance was found to be severely irritating to eyes (OECD 405).
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:
- September 1985
- 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
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: GAUKLER, OFFENBACH/MAIN, Germany
- Weight at study initiation: mean 2.63 kg
- Housing: single housed in a cage made of stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm
- Diet: Kliba 341, 4 mm, Firma Klingentalmuehle ag ch-4303 Kaiseraugst. Switzerland (about 130 g per animal per day)
- Water: 250 ml, tap water
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): fully air-conditioned room
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light from 6:00 AM to 6:00 PM - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution): 50 % aqueous formulation w/w
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g of the suspension - Duration of treatment / exposure:
- 1 hour
- Observation period:
- 30 - 60 minutes after removal of the test patches and 24 h. 48 h, 72 h, after the beginning of application
- Number of animals:
- 3 male rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: 0.5 mm layer, test patches are secured in position with a porous dressing (four layers of absorbent gauze + porous bandage).
SCORING: Draize - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24 h
- Max. score:
- 4
- Remarks on result:
- not determinable
- Remarks:
- red staining by test item
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema 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 irritation
- Other effects:
- The substance caused red staining at 1 and 24 h. Therefore, erythema could not be determined appropriately. However, no signs of redness were observed at 48 and 72 h.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not irritating to rabbit skin according to an OECD 404 study. The substance is not classifiable.
- Executive summary:
The skin irritation potential of Basic Red 46 was evaluated in a study conducted according to OECD Test Guideline 404. The test was performed on 3 adult male Vienna White rabbits. Gauze patches of 2.5 x 2.5 cm² laden with 0.5 ml of the test material were applied to the shaved skin. Due to intensive staining by the test compound erythema was not assessable at the 1-hour and 24-hour evaluation time; at 48 and 72 h, no erythema was observed. No oedema was observed at either evaluation time-point. Based on the findings of the study, Basic Red 46 was found to cause no irritation when applied to rabbit skin.
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:
- September 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: GAUKLER, OFFENBACH/MAIN, Germany
- Weight at study initiation: mean 2.63 kg
- Housing: single housed in a cage made of stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm
- Diet: kliba 341, 4 mm, firma klingentalmuehle ag ch-4303 kaiseraugst. switzerland (about 130 g per animal per day)
- Water: 250 ml, tap water
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): fully air-conditioned room
- Photoperiod (hrs dark / hrs light): 12 hours cycle dark/light from 6:00 AM to 6:00 PM - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 1 treatement at 0 h
- Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: Draize
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2.33
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Max. score:
- 2
- Remarks on result:
- not determinable
- Remarks:
- staining by substance
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- other: all animals
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 3.67
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- probability of severe irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 4
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks on result:
- probability of severe irritation
- Irritant / corrosive response data:
- The test item caused moderate to severe reaction in rabbit eyes. Loss of corneal tissue was observed and the study discontinued at 72 h because of the severe irritation reactions for animal welfare reasons.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- The substance caused severe damages in rabbit eyes which were not considered reversible.
- Executive summary:
The eye irritation potential of Basic Red 46 was evaluated in a study conducted according to OECD Test Guideline 405. The test was performed on 3 adult female Vienna White rabbits. The test material in an amount of 0.1 ml (ca. 78 mg) was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. No washing was done. The eye irritation was evaluated 1, 24, 48, and 72 hours after treatment and was scored for each individual rabbit. Based on the available data, the corneal opacity was scored to be ≥ 2 all 3 rabbits which was not reversible within the 72 hours observation time. In addition, chemosis was scored to be ≥ 3 in all 3 rabbits which was also not reversible. Hence, it was concluded that the instillation of the substance in eye, leads to irreversible effects on the eyes, and should be classified in category 1 as per the Regulation EC No. 1272/2008 (CLP) criteria.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The skin irritation potential of Basic Red 46 was evaluated in a study conducted according to OECD Test Guideline 404. The test was performed on 3 adult male Vienna White rabbits. Gauze patches of 2.5 x 2.5 cm² laden with 0.5 ml of the test material were applied to the shaved skin. Due to intensive staining by the test compound erythema was not assessable at the 1-hour and 24-hour evaluation time; at 48 and 72 h, no erythema was observed. No oedema was observed at either evaluation time-point. Based on the findings of the study, Basic Red 46 was found to cause no irritation when applied to rabbit skin.
The eye irritation potential of Basic Red 46 was evaluated in a study conducted according to OECD Test Guideline 405. The test was performed on 3 adult female Vienna White rabbits. The test material in an amount of 0.1 ml (ca. 78 mg) was inserted into the conjunctival sac of the left eye of the rabbits and the lids were gently closed for a few seconds. The right eye was not treated and served as an untreated control. No washing was done. The eye irritation was evaluated 1, 24, 48, and 72 hours after treatment and was scored for each individual rabbit. Based on the available data, the corneal opacity was scored to be ≥ 2 all 3 rabbits which was not reversible within the 72 hours observation time. In addition, chemosis was scored to be ≥ 3 in all 3 rabbits which was also not reversible. Hence, it was concluded that the instillation of the substance in eye, leads to irreversible effects on the eyes, and should be classified in category 1 as per the Regulation EC No. 1272/2008 (CLP) criteria.
Justification for classification or non-classification
GHS Category 1 - H318
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