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Diss Factsheets
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EC number: - | 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
not skin and eye irritant
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- in vivo
- Type of information:
- other: read across from similar substance
- Adequacy of study:
- weight of evidence
- Study period:
- From August 27,1985 to October 10,1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant with international guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:Hoechst AG
- Age at study initiation: 3-5 months
- Weight at study initiation: 3.1-3.3 kg
- Housing:in air-conditioned room in individual cages (battery cages)
- Diet : Altromin 2123 - Rabbit Altromin GmbH
- Water : deionized water, chlorinated water ad libitum from automatic drinking
ENVIRONMENTAL CONDITIONS
- Temperature (°C):20 ± 3 °C
- Humidity (%):50 ± 20 %
- Photoperiod : 12 hours cycle dark/light - Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- physiological saline
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount: 500 mg - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 30 min , 60 min , and 24, 48, 72 hours later and 7, 14 days
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure:25 cm^2
- Type of wrap if used:semiocclusive bandage
REMOVAL OF TEST SUBSTANCE
- Washing: with water
SCORING SYSTEM: erythema , edema - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hrs
- Score:
- ca. 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 Hrs
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 72 Hrs
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Reactive Orange 16 similar substance 1 is non-irritating and is not subject to classification.
- Executive summary:
The skin irritation test in rabbits showed that the similar substance 1 in this study, based on the criteria for classification Directive 83/467/EEC , is non-irritating and is not subject to classification.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- in vivo
- Type of information:
- other: read across from similar substance
- Adequacy of study:
- weight of evidence
- Study period:
- Since August 27,1985 to August 30,1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliance with international guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: 83/467/EWG: 29 july 1983
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3-5 months
- Weight at study initiation: 3,1 - 3,2 kg
- Housing: fully air-conditioned rooms in individual cages (battery cages)
- Diet: Altromin 2123 maintenance diet - Rabbits, ad libitum
- Water: deionized water, chlorinated water from the tables and drank ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 50 ±20 %
- Photoperiod: 12 hours cycle dark/light - Vehicle:
- water
- Remarks:
- isotonic salt solution
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Concentration: 100 mg in conjunctival sac of left eye
VEHICLE
- Amount(s) applied: 0.1 ml
- Source: Fresenius AG - Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 1, 24, 48, 72 hours and 7 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: yes, with water
SCORING SYSTEM: according to OECD 405 (cornea, iris, conjunctiva)
TOOL USED TO ASSESS SCORE: fluorescein (evaluation at 24 and 72 hours)
24 hours before the start of the study were treated to the sight of animals after instillation of one drop of sodium fluorescein (0.01%) are examined under ultraviolet light for any damage to the cornea. There were only taken in experimental animals, whose eyes have not shown results. - Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 Hrs
- Score:
- ca. 0
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- ca. 0
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- ca. 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The eye irritation test in rabbits showed that the similar substance 1, on the present study according to the classification criteria of Directive 83/467/EEC, is non-irritating and is not subject to classification.
- Executive summary:
- The eye irritation test in rabbits showed that the similar substance 1, on the present study according to the classification criteria of Directive 83/467/EEC, is non-irritating and is not subject to classification.
Reference
Table of individual data:
time after administration | 1h | 24h | 48h | 72h | ||||||||
n° of animals | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 |
conj. Chemosis | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
conj. redness | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Iris | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Cornea opacity | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
fluorescien test | 0 | 0 | 0 | 0 | 0 | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
All studies confirm that Reactive Orange 16 is not irritant for skin, eye and respiratory tract.
Justification for classification or non-classification
Based on regulation 1272 -2008 "Eye irritation means the production of changes in the eye following the application of test substance to the anterior surface of the eye, which are fully reversible within 21 days of application." All study results indicate that reactive orange 16 doesn't show any effect on eye. No classification is necessary.
Based on 1272 -2008 regulation, table 3.2.2 (concerning skin irritation) the results are to low for classification and are fully reversible within 24h. No classification is necessary.
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