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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
LD50 oral rat = 2000 mg/kg bw
LC0 inhl rat = 3930 mg/m^3 air
LD0 dermal rat =1714 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 2,1993 to February 24,1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant with international guidelines
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Strain: Hoe: WTSKf(SPF71)
- Age at study initiation:male 8 weeks, females 7 weeks
- Weight at study initiation:
males (x)= 184 g s=±6 g xmin=176 g (-4.4%) xmax= 193 g (+4.8%)
females (x)= 166 g s=±5 g xmin=160 g (-3.7%) xmax= 174 g (+4.8%)
- Fasting period before study: from about 16 hours before to 3 - 4 hours after treatment.
- Housing: in fully air-conditioned rooms in Makrolon cages (Type 4) on soft wood granulate in groups of 5 animals
- Diet: Altromin 1324 rat diet, ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: not necessary (breeding at extensive identical conditions)
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Humidity: 55±20%
- Photoperiod: 12 hours cycle dark/light - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% suspension, 10 ml/kg bw
PREPARATION OF THE SUBSTANCE
- Remazol-Brillantorange 3R was suspended in the stated concentration in deionized water and distributed homogeneously by means of a magnetic stirrer. Stability and homogeneity of the test substance was determined by analytical methods. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 x sex x dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:twice every day
- Necropsy of survivors performed: yes, at the end of the observation period the animais were killed by carbon dioxide asphyxiation, dissected and examined for macroscopically visible changes.
- Other examinations performed: clinical signs, body weight,organ weights. - Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No deaths occurred during the whole study.
- Clinical signs:
- other: No symptoms were observed after application of 2000 mg/kg body weight. Feces and bedding were discoloured reddish at the first day of the study.
- Gross pathology:
- The animals kilied at the end of the observation period showed no macroscopically visible changes.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acute oral toxicity testing of Reactive Orange 16 in the Wistar rat yielded a median lethal dose above 2000 mg/kg b.w. No deaths occurred during the whole study.
- Executive summary:
Acute oral toxicity testing of Reactive Orange 16 in the Wistar rat yielded a median lethal dose above 2000 mg/kg b.w. in both male and female animals. After application of 2000 mg/kg b.w. neither deaths nor symptoms occurred. Feces and bedding were discoloured reddish at the first day of the study. Development of body weight was not impaired. The animals killed at the end of the observation period showed no macroscopically visible changes.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- since September 22,1994 to October 06,1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Not GLP compliance but good described.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- fixed concentration procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Velaz (Prague)
- Age at study initiation: 8 weeks
- Weight at study initiation:male 176.4 +/- 14 g and female 160.8 +/- 6.35
- Fasting period before study: NO
- Housing:Plastic cage T4 (550 x 320 x 180 mm Velaz Praga)
- Diet :Fed with a mixture granulated food ALTROMIN 1320 (Velaz Prague) in a dose of 12 grams per day
- Water : ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ± 3 °c
- Humidity (%): 40 - 60 %
- Photoperiod : 12 h cycle dark/light - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- head only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: wright Dust Feed Unit MK2, GA 4170, L. Adams LTD., London
- Method of holding animals in test chamber:The animals were fixed in glass tubes with a diameter of 60 mm so that the face of interfering with the glass cylinder , a vertical axis,- an average of 250 mm, where there has been a dynamic linear rate changing atmosphere of 10 L / min.
- Source and rate of air: 0.6 m^3 /h
- Method of particle size determination: mycroscope
- Source and rate of air: dynamic hair system
- System of generating particulates/aerosols:through the spray unit so that the atmosphere at 'inside the inhalation chamber was homogeneous.
- Temperature, humidity, pressure in air chamber:
TEST ATMOSPHERE
- Brief description of analytical method used: Compressed air was drawn from a distribution center and Synthesia air flow was measured continuously during exposure time. The unit load was maintained 10 mm water column (pressure). Temperature and humidity were measured continuosly
- Samples taken from breathing zone: yes - Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- ca. 4 h
- Concentrations:
- measuerd concentration: 4.85 mg/L L Air
- No. of animals per sex per dose:
- 5 x sex x dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 2 per day
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, water and food consumption - Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- >= 4.85 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- ca. 3.93 mg/L air
- Based on:
- act. ingr.
- Exp. duration:
- 4 h
- Mortality:
- no mortality observed
- Clinical signs:
- other: other:
- Body weight:
- no change observed
- Other findings:
- Immediately after the 14 days after the observation period the animals were killed by cervical spine, disruption spinal cord and blood vessels of the neck. After an autopsy was performed, with particular attention to the comprehensive examination of the body surface and orifices, and macroscopic examination of the chest, abdominal organs and trachea, lungs, heart , liver, spleen and kidneys.
In this examination is done for all males and two females. - Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The substance Reactive Orange 16 is practically non toxic for a short time exposure. It shows a LD0= 4.85 mg/L (3.93 mg/L active ingredient)
- Executive summary:
- The sample Reactive Orange 16 was tested for acute inhalation toxicity limit. The test was performed according to OECD method No. 403. Experimental animals (10 rats Vistar strain) were exposed to inhalation of powder spray test substance for 4 hours of inhalation chamber. The concentration of test substance was measured by the gravimetric method. Prior exposure was measured microscopically initial size of the particles of the sample. The size of most particles ranged from 2 to 4 microns. Particle size is one of the limiting factors in the deposition of inhaled substances in different areas of the respiratory system. During exposure or during the period of 14 days of observation, there was no mortality of test animals. Clinic health disturbance of the animals tested respondents can be described as the result of the effect mechanically irritating dust spray on exposed mucous membranes and upper respiratory tract (HCD). Pathological-anatomical examination found in the lungs of three females, indicative of lung deposit of particles. tested substances with the subsequent development of obstructive atelectasis.
Reference
Immediately after application:
the
animals were removed from the tubes, placed in cage and observed.
In
all cases, it was noted bristly hair on the head and front legs of the
sample spots.The nasal cavities and eyes were visible orange tears .
Breath was regular, the number of breaths per minute 100 -110. Physical
and mental mental disorders were founded . the
animals werewashedand giventhem food.
60
minutes after application:
Were
observed in the same clinical signs of intoxication,as inprevious
examinations.
120
minutes after application:
Were
observed the same clinical symptoms as in the previous examination.
2
daysafter application:
In
addition to hair contact with the substance tested, in different parts
of the body, they had disturbances in health.
3
to 14 days after application:
At
this time there are no clinical symptoms
Discussion:
Before
the test was measured by the size of microscopic particles of the sample
Ostazinová V3R orange. Most particles are ranged from 2 to 4 µm.The
particle size is a limiting factor to save inhaled substances in
different parts of the respiratory system.
In
general, the biological activity of the deposition in the regions of the
respiratory tract depends on the physical propertiesof the particles.The
chemical nature of these particles is of secondary importance. Their
size, weight, shape, texture and solubility are limiting factors. Larger
and heavier particles easily adhere to the mucos of the upper
respiratory tract (HCD). In the nasal cavity, the mucosal lining of the
trachea and bronchiis greater. These trapped particles are expelled from
the mucos of the mouth after swallowing, and can be absorbed in the
digestive tract. The deepest parts of the lung (respiratory bronchioles,
alve wolari bifurcations) are virtually marked. It is these particles,
although only asmall part of them to penetrate these areas, they are
responsible for the birth and development of lung diseases caused by
particles (Varheitetal.,1990).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 3 930 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- other: read across from supporting substance
- Adequacy of study:
- key study
- Study period:
- From July 15,1985 to July 29 ,1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant with international guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF-Zucht
- Age at study initiation:male 7 weeks old , females 10 weeks old
- Weight at study initiation:male 184-200 g , female 189-219
- Fasting period before study:
- Housing: individually housed in air-conditioned rooms in Makrolon cages (type 3) on softwood pellets
- Diet : altromin 1324, ad libitum
- Water : tap water in plastic bottle, ad libitum
- Acclimation period:5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ±°C
- Humidity (%):50 ± 20%
- Air changes (per hr):fully air condition
- Photoperiod (hrs dark / hrs light):12 hours cycle dark/light - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure:30 cm^2
- % coverage: 6 x 8 cm
- Type of wrap if used:
aluminum-foil (6 x 8 cm) and one elastic. The elastic is used to fix around the body of the animal the aluminium foil (Elastoplast, 8 cm).
REMOVAL OF TEST SUBSTANCE
- Washing :yes
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):Reactive Orange 64 258 FW F-ratio was 1.0 g + 0.50 ml moistened with isotonic saline solution (sterile, pyrogen-free, supplied by Fresenius AG).
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals x sex x dose
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:every weeks
- Necropsy of survivors performed: yes - Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 1 714 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- no mortality observed
- Clinical signs:
- other: no clinical signs observed
- Gross pathology:
- no pathology observed
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No mortality, irritation or any clinical signs observed during study. LD0= 2000 mg/kg bw (1714 mg/kg based on active ingredient)
- Executive summary:
The similar substance 1 was examined for acute dermal toxicity in Wistar rat male and female a lethal dose media (LD50) of 2000 mg / kg body 1714 based on activ ingredient weight. After administration of 2000 mg / kg bw no deaths or related symptoms are observed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 714 mg/kg bw
Additional information
Reactive orange 16 show no toxicity by oral administration, with a LD50 = 2000 mg/kg bw.
The toxicity of reactive orange 16 is also low by inhalation route. No mortality was observed during the experiment but many rat show a lung problems.
Dermal route was examined for acute toxicity with Wistar rat male and female. After administration of 1714 mg / kg bw no deaths or any related symptoms are observed. It can confirm the non toxicity for dermal exposure.
Justification for classification or non-classification
Substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria shown in Table 3.1.1 of CLP Regulation. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE). The limit value that can trigger to Classification is 2000 mg/Kg both for oral exposure pattern and 5 mg/L for inhalation powder exposure. The only test that actually demonstrates no classification for acute toxicity under regulation 1272/2008 is the oral acute. For the other two exposure pathway the limit concentration has not be measured on pure substance, but on formulation, therefore the effect has been reported at concentration of the pure substance slightly under the related trigger value. Taking into account that no effect at all has been reported at 3.93 mg/L for inhalation , and 1714 mg/kg for dermal it can be assumed that :
No classification for acute toxicity oral is warranted under Regulation 1272/2008
No classification for acute toxicity inhalation is warranted under Regulation 1272/2008
No classification for acute toxicity dermal is warranted under Regulation 1272/2008
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