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Diss Factsheets
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EC number: 274-700-1 | CAS number: 70616-89-6
- 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
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:
- supporting study
- Study period:
- 1976
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study report contains the limited information on the test conditions because the study has been performed in 1976. However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - Sex: male
- Type of coverage:
- not specified
- Preparation of test site:
- not specified
- Vehicle:
- not specified
- Controls:
- no
- Amount / concentration applied:
- 0.5 g
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: later observation
- Score:
- 0
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- non-irritating
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Specific details on test material used for the study:
- None
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf - Age at study initiation: 12 - 14 weeks - Weight at study initiation: 2300-2600 g - Housing: Animals were housed individually in metal cages - Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland) ad libitum - Water (e.g. ad libitum): water ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 20±3° C - Humidity (%): 30-70 % - Air changes (per hr): 12 hours light/day - Photoperiod (hrs dark / hrs light): approximately 15 air changes/h.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- A gauze patch bearing 0.5 ml of the test substance was applied to the skin
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours
- Number of animals:
- 3 males
- Details on study design:
- None
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings .
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40170/B is to be considered as a non-irritant to the skin of rabbits.
- Executive summary:
A study was performed to determine the acute irritation, provoked by the compound, FAT 40170, on the skin of the rabbits according to the OECD guidelines for testing of chemicals: Acute dermal Irritation/Corrosion No. 404, adopted May 12, 1981 by the OECD Council. 6 rabbits, Albino White breed, were shaved and the test substance applied on abraded and intact skin of the animals. A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape (ISOPLAST AG, CH-5200 Brugg). The substance was water moistened before application. After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme, after 1, 24, 48, 72 hours and during the following observation period. There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings.Therefore FAT 40170/A is to be considered as a non-irritant to the skin of rabbits.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1983
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Specific details on test material used for the study:
- None
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf - Age at study initiation: 12 - 14 weeks - Weight at study initiation: 2030-2080 g - Housing: Animals were housed individually in metal cages. - Diet (e.g. ad libitum): Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum - Water (e.g. ad libitum): water ad libitum ENVIRONMENTAL CONDITIONS - Temperature (°C): 20±3° C - Humidity (%): 30-70 %; - Air changes (per hr): 12 hours light/day - Photoperiod (hrs dark / hrs light): 15 air changes/h.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g of the test substance was applied to the skin
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, 72 hours
- Number of animals:
- 3 males
- Details on study design:
- None
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.2
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings .
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40170/B is to be considered as a non-irritant to the skin of rabbits.
- Executive summary:
A study was performed to determine the acute irritation, provoked by the compound, FAT 40170, on the skin of the rabbits according to the OECD guidelines for testing of chemicals: Acute dermal Irritation/Corrosion No. 404, adopted May 12, 1981 by the OECD Council.
Six rabbits, Albino White breed, were shaved and the test substance applied on abraded and intact skin of the animals. A gauze patch bearing 0.5 g of the test substance was applied to the skin and loosely held in place by adhesive but non irritating tape (ISOPLAST AG, CH-5200 Brugg). The substance was water moistened before application. After removal of the dressings the skin reaction was assessed on the basis of an evaluation scheme, after 1, 24, 48, 72 hours and during the following observation period. There was no observable response to treatment in any of the six animals at the 24 hours or the 72 hours readings.Therefore FAT 40170/B is to be considered as a non-irritant to the skin of rabbits.
Referenceopen allclose all
None
None
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:
- supporting study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The study report contains the limited information on the test conditions because the study has been performed in 1991. However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 g
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Score:
- > 0 - < 1
- Max. score:
- 3
- Reversibility:
- not specified
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- non-irritating
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1963
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Specific details on test material used for the study:
- None
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf- Age at study initiation: 12 - 14 weeks- Weight at study initiation: 2130-2560 g- Housing: Animals were housed individually in metal cages.- Diet (e.g. ad libitum): rabbit food ad libitum- Water (e.g. ad libitum): water ad libitumENVIRONMENTAL CONDITIONS- Temperature (°C): 20±3° C- Humidity (%): 30-70 %- Air changes (per hr): approximately 15 air changes/h.- Photoperiod (hrs dark / hrs light): 12 hours light/day
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- not specified
- Amount / concentration applied:
- 0.1 g of the test article was placed into the conjunctival sac of the right eye of each animal
- Duration of treatment / exposure:
- The lids were then held together for about one second in order to prevent loss of the test material.
- Duration of post- treatment incubation (in vitro):
- 1, 24, 48, 72 hours
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- None
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.9
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- None
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40170 is considered to be a non-irritant to the eyes.
- Executive summary:
In a study performed to determine the eye irritation potential of FAT 40170, test substance was instilled in the eyes of 3 rabbits and observations for irritation were recorded at the time points of 1, 24, 48 and 72 hours. The body weight in 1 animal was decreased during the test period. No other reactions to treatment were recorded during the whole observation period. Based on these findings, FAT 40170 is considered to be a non-irritant to the eyes.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1963
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- None
- GLP compliance:
- no
- Specific details on test material used for the study:
- None
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf- Age at study initiation: 12 - 14 weeks- Weight at study initiation: 2500 - 2700 g- Housing: Animals were housed individually in metal cages.- Diet (e.g. ad libitum): rabbit food ad libitum- Water (e.g. ad libitum): water ad libitumENVIRONMENTAL CONDITIONS- Temperature (°C): 20±3° C- Humidity (%): 30-70 %- Air changes (per hr): approximately 15 air changes/h.- Photoperiod (hrs dark / hrs light): 12 hours light/day
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- 0.1 ml of the test article was placed into the conjunctival sac of the right eye of each animal.
- Duration of treatment / exposure:
- The lids were then held together for about one second in order to prevent loss of the test material.
- Duration of post- treatment incubation (in vitro):
- 1, 24, 48, 72 hours
- Number of animals or in vitro replicates:
- 3 animals
- Details on study design:
- None
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- None
- Other effects:
- None
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- FAT 40170/A is considered to be a non-irritant to the eyes.
- Executive summary:
In a study performed to determine the eye irritation potential of FAT 40170, test substance was instilled in the eyes of 3 rabbits and observations for irritation were recorded at the time points of 1, 24, 48 and 72 hours. The body weight development was not affected by the application of the test article. No other reactions to treatment were recorded during the whole observation period. Based on these findings, FAT 40170/A is considered to be non-irritant to the eyes.
Referenceopen allclose all
None
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
No adverse effect was found on skin or eye. Reactive Orange 13 does not meet the criteria for classification according to 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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