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Diss Factsheets
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EC number: 943-269-8 | CAS number: 6598-63-6
- 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
- Type of information:
- other: experimental result from similar substance
- Adequacy of study:
- key study
- Study period:
- From 6 to 9 march 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable for the assessment of the endpoint.
- 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
- Remarks:
- This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- semiocclusive
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied: 0.5 g
- Duration of treatment / exposure:
- Single 4 hours application
- Observation period:
- 1, 24, 48 and 72 hours after administration
- Number of animals:
- 3
- Details on study design:
- SCORING SYSTEM:Primary irritation index / classification- 0: non-irritant- >0-2: mild irritant- >2-5: moderate irritant- >5-8: severe irritant
- Irritation parameter:
- other: Erythema/eschar formation
- Basis:
- other: 65954 male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- ca. 0
- Irritation parameter:
- other: Erythema/eschar formation
- Basis:
- other: 65956 male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- ca. 0
- Irritation parameter:
- other: Erythema/eschar formation
- Basis:
- other: 65957 male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- other: 65954 male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- other: 65956 male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- ca. 0
- Irritation parameter:
- edema score
- Basis:
- other: 65957 male
- Time point:
- other: 1, 24, 48 and 72 hours
- Score:
- ca. 0
- Irritant / corrosive response data:
- Primary irritation index: 0.0No evidence of skin irritation was noted. Red-coloured staining was noted at two treated skin sites one hour after patch removal.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.
- Executive summary:
A study was performed to assess the initation of the test material to the skin of the New Zealand White rabbit (SPL Standard Test Method 540.10). The method followed OECD Guidelines for Testing of Chemicals (24 April2002) No. 404 "Acute Dermal Initation/Corrosion" and Method B4 of Commission Directive 2004/73/EC (which constitutes Annex V of Council Directive 671548/EEC). The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.
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:
- other: experimental result from similar substance
- Adequacy of study:
- key study
- Study period:
- From 12 to 26 march 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable for assess the endpoint.
- 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
- Remarks:
- This study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme, but the study report has not been audited by the QA Unit. No formal claim of GLP compliance is made for this study.
- Species:
- rabbit
- Strain:
- New Zealand White
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied: single application of 0.1 ml (76.6 mg)
- Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 1, 24, 48 amd 72 hours and 7 days after administration
- Number of animals or in vitro replicates:
- 3
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- animal: All rabbits (65967, 66032 and 66033 males)
- Time point:
- 24/48/72 h
- Score:
- ca. 10
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- The test material produced moderate conjunctival irritation. Dark red-coloured staining of the lower conjunctival and nictitating membranes and red-coloured staining of the fur around the treated eye were also noted. One treated eye appeared normal at the 72-hour observation and the two remaining treated eyes appeared normal atthe 7-day observation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material did not meet the criteria for classification as irritant according to EU labelling regulations.
- Executive summary:
A study was performed to assess the irritation of the test material to the eye of the New Zealand White rabbit (SPL Standard Test Method 560.09), The method followed OECD Guidelines for Testing of Chemicals (24 April 2002) No. 405 "Acute Eye Initation/Corrosion" and Method B5 of Commission Directive 2004/73/EC (which constitutes Annex V of Council Directive 67/548/EEC).
The test material did not meet the criteria for classification as irritant according to EU labelling regulations.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Based on the results of the available in vitro and in vivo tests, no skin irritating effects were observed.
Eye irritation
Based on the results of the available in vitro and in vivo tests, no eye irritating effects were observed.
Respiratory irritation
Tests on this pourpose have not been conducted; nevertheless Direct Orange 102 is not expected to be a respitatory irritant.
Justification for classification or non-classification
According to CLP regulation (EC 1272/2008) Direct Orange 102 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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