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Diss Factsheets

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
Reference
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.

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
Reference
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.

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).

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.
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
Reference
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.

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