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Diss Factsheets
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EC number: 220-027-3 | CAS number: 2610-10-8
- 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
Non skin irritating
Non irritating to eye
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test was performed following official guideline and meets generally accepted scientific principles, acceptable for assessment.
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the safety of Chemicals in Food, Drugs and Cosmetics (1959) of the US association AFDO
- Deviations:
- not specified
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Age at study initiation: adult animals- Weight at study initiation: 1.5 - 2 kg- Housing: single housing in V2A wire cages- Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)- Water: ad libitum
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved intact and scarified skin
- Vehicle:
- other: polyethylene glycol 100%
- Controls:
- other: untreated skin of same animal
- Amount / concentration applied:
- TEST MATERIAL- Amount applied: 0.5 g- Concentration: 50%
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6 (3 males + 3 females)
- Details on study design:
- TEST SITE- Area of exposure: 2.5 cm x 2.5 cm on back and flank- Type of wrap: plastic films of 5 x 5 cm fixed to the body with adhesive tape
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No irritant response data after a 24-hours occlusive exposure to intact skin. The primary irritaion index is 0.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material is not irritating to the rabbit skin.
- Executive summary:
The test item was tested for skin irritation and the test results showed a primary irritation index of 0 in all the trated animals.
Direct Red 80 could be considered as a not skin irritant.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The test was performed following official guideline and meets generally accepted scientific principles, acceptable for assessment.
- Qualifier:
- according to guideline
- Guideline:
- other: Appraisal of the safety of chemicals in Foods, Drugs and Cosmetics (1959) of the association (AFDO).
- Deviations:
- not specified
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- other: Russian Breed
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Exp. Toxicology, CIBA-Geigy Ltd.- Housing: single housing in V2A wire cages - Diet: standard rabbit food ad libitum (NAFAG, No. 814, Gossau SG)- Water: ad libitum
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of same animal
- Amount / concentration applied:
- TEST MATERIAL- Amount applied: 0.1 g
- Duration of treatment / exposure:
- few seconds
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6 (3 males + 3 females)
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing: In 3 of the 6 rabbits approximately 30 seconds after treatment the treated eye was flushed with 10 ml of physiological saline.SCORING SYSTEM: according to DraizeTOOL USED TO ASSESS SCORE: hand-slit lamp
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unrinsed and rinsed
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: unrinsed and rinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- fully reversible within: 96 hours
- Remarks on result:
- other: unrinsed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 hours
- Remarks on result:
- other: rinsed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- The tested substance showed some irritating effect on conjunctivae during the first 24 hours but the irritation signs were fully reversible within 96 hours for the unrinsed eyes. No effects on iris and on cornea.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this experiment the test material was found to cause a minimal irritation during the first 24 hours, the irritation effects were fully reversible within 96 hours for the unrinsed eyes. The test material is considered to be not irritating to the eye.
- Executive summary:
Based on the test results, the test material is considered to be not irritating to the eye.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Three studies on four are according to identify Similar Substance 01 as skin not irritating; Clariant 2002 study has been performed with a concentration of 87.5% and Clariant 2007 with a cocentration of 70%.
The studies on structural analogues Similar Substance 02 and 03 confirm the not irritability for skin .
Eye irritation
It was noted that test material produced moderate conjunctival irritation, reported in Clariant 2007 report. It is possible that similar substance 01 could be irritating to eye in some conditions, expecially if in powder form; however the eventually disadvantages can be easy obviated by correctly using of the substance with the necessary preautions.
In any case none of those effects are enough to classify the substance as irritant, according to CLP regulation (EC1272/2008).
Respiratory irritation
Tests on this pourpose have not been conducted; nevertheless Direct Red 80 is not expected to be a respitatory irritant.
Justification for classification or non-classification
According to CLP regulation (EC1272/2008) the tested substance is not classified as skin/eye/respiratory irritant.
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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