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Reaction mass of tetrasodium 3-[[4-[[4-[(6-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-6-sulphonato-1-naphthyl]azo]-1-naphthyl]azo]naphthalene-1,5-disulphonate and tetrasodium 3-[[4-[[4-[(6-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-7-sulphonato-1-naphthyl]azo]-1-naphthyl]azo]naphthalene-1,5-disulphonate
EC number: 911-640-3 | CAS number: -
- Life Cycle description
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- Appearance / physical state / colour
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- Boiling point
- Density
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- Flash point
- Auto flammability
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- Oxidation reduction potential
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- Endpoint summary
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- Environmental data
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- 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
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- Toxicological Summary
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Endpoint summary
Administrative data
Description of key information
LD50, oral, rat = 5000 mg/kg bw /day (LD0)
LC50, inhalation, rat = 5000 mg/m3
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:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- no
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- HealthySpregue-Dawley RAI.f. (SPF) (Ra25) derived rats were used. These were bred on the premises. Aged 6-7 weeks, and had an average body weight of 154 g. (male) and 127 g. (female).
Rats were caged singly and kept in a room maintained at a temperature of 21°C. Animals were subjected to 12 hours artificiale light and 12 hours darkness in each 24 hour period. A commercial autoclavable pelleted diet (Labsure CMR Rat and mouse nuts) was fed and lib. Water filtered at 0.45 micron was available at all times. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- A 25% w/v suspension of the compound in a 0.5% aqueous solution of carboxymethyl cellulose was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a rate of 20ml/kg. (equivalent to 5g/kg of compound)
- Doses:
- 5g/kg
- No. of animals per sex per dose:
- 5 females and 5 males per dose
- Control animals:
- no
- Details on study design:
- After administration of the compound, the animals were observed for 14 days. Death and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no death
- Clinical signs:
- other: no abnormalities
- Gross pathology:
- dark kidney surfaces in 3/5 male and 4/5 female animals
- Other findings:
- Black stained urine and faeces were seen from 3 hours up to 6 days post dose. No abnormalities were seen from day 7 until the study terminated on day 14. At terminal autopsy the only abnormalities noted were dark kidney surfaces in 3/5 male and 4/5 female animals.
- Interpretation of results:
- other: not classigied under Regulation 1272/2008
- Conclusions:
- The substance was tested for acute toxicity oral follwoing OECD 420. Under the experimental conditions the substance showed LD50 (LDo= > 5000 mg/kg and did not show any toxicity signs over the 14 days period of observation
- Executive summary:
The substance was tested following OECD 420. Ten rats, five males and five females, were kept and fed in the same conditions by a 25% w/v suspension of the compound in a 0.5% aqueous solution of carboxymethyl cellulose. The substance was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a rate of 20ml/kg. (equivalent to 5mg/kg of compound). After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. No abnormalities were seen from day 7 until the study terminated on day 14. At terminal autopsy the only abnormalities noted were dark kidney surfaces in 3/5 male and 4/5 female animals. The substance can be considered as non toxic at doses ca. 5000 mg(kg bw
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 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:
- September 27, 1994 to October 11, 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- acute toxic class method
- 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
- Supplier certification: declared that animals had not the external and internal parasites, pathogenic microorganisms, viruses and fungi.
- Housing: after transporting the animals were placed in polypropylene plastic nursery containers T4 (550 x 320 x 180 mm Velaz Prague), five animals each sex separately.
- Diet: fed with granulated mixture ALTROMIN 1320 (Velaz Prague) in a dose of 12 g per animals each day
- Water: drinking water without restrictions
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 40-60 %
- Photoperiod: 12 hours of light and 12 hours of darkness - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- head only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: samples were dispensing by WDFU (Wright Dust Feed Unit MK2, GA 4170, L. Adams, LTD., London) to an inhalation chamber, where they w ere dispersed through the spray; the atmosphere inside the inhalation chamber was homogeneous.
- Method of holding animals in test chamber: animals were fixed in a glass tube of diameter 60 mm so that the face of the glass cylinder to interfere with the vertical axis - 250 mm in diameter- in which there was a linear dynamic atmosphere exchange at 9 l/min.
- Source and rate of air: compressed air was taken from the central distribution Synthesia. Air flow was measured continuously throughout the exposure.
TEST CONDITIONS
- The average air flow apparatus: 0.540 m3/h
- The temperature inside the apparatus: 24°C
- Relative humidity inside the apparatus: 50%
- Actual concentration: 5.16 mg/L air
TEST SUBSTANCE
- Particle size of the test substance: :
diameter 1-4 um: 78,65%
diameter 4-10 um: 16,00%
diameter 10-20 um: 4,37%
diameter >20 um: 0.98% - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- ca. 4 h
- Concentrations:
- 5.16 mg/l air
- No. of animals per sex per dose:
- 5 males and 5 non-pregnant females.
- Control animals:
- yes
- Details on study design:
- - Immediately after application the animals were removed from tube, placed in breeding containers and observed.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at immediatly after exposure, 7 and 14 day
- Other examinations performed: clinical diagnosis was focused on the observation of nutritional status (food intake and water), the appearance of hair and skin, visible mucous membranes, mental activity, somatomotor activity, response to stimuli, focusing on sensitization and reactivity, lacrimation, functional assessment of the respiratory, circulatory, digestive and urogenital apparatus.
- After 14 days the animals were killed and an autopsy was performed. At autopsy were examined macroscopically thoracic and abdominal organs and lungs, trachea, larynx, thymus, liver, spleen and kidneys. - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- ca. 5 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: also LC0
- Mortality:
- During the exposure there was no mortality of animals tested.
- Clinical signs:
- other: Clinical signs were due to mechanical irritant effect of aerosol dust on exposed mucous membranes and upper respiratory track. The main signs were: the swelling of the eyelids, runny eyes and nasal. Motor disorders of the forelegs and of the tails were ob
- Body weight:
- The increase of body weight of animals tested was in according to the trend of increase of control animals.
- Gross pathology:
- Immediately after the 14-day observation period the animals were killed . After an autopsy was performed, focusing on the overall examination of the body surface and orifices, and macroscopic examination of the thoracic, abdominal and selected organs - trachea, lungs, heart, thymus, liver, spleen and kidneys.In one male and in one female were presents haemorrhages in the lungs. In both cases, these haemorrhages were located under the pulmonary pleura. In one female were found congested kidneys
- Other findings:
- Potential target organs:Trachea , lungs, heart,thymus, liver , spleen and kidneys.
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- The substance was tested for acute toxicity by inhalation following OECD 403. Under the experimental conditions the LC50 (LC0) resulted equal to 5.16 mg/l (dust aerosol).
- Executive summary:
The substance was tested for acute inhalation toxicity following OECD 403. The test was performed on 10 rats WISTAR strain, that were exposed to inhalation of dust aerosol test substance for 4 hours in the inhalation chamber. The test chemical concentration was measured gravimetric method. The size of most particles ranged from 2 to 4 µm. Particle size is one of the limiting factors in the deposition of inhaled substances in different areas of the respiratory apparatus.
During the exposure or during the 14-day observation period, there was no mortality of test animals.
Clinical signs of intoxication can be described as the result of mechanically irritating dust aerosol effect on exposed mucous membranes and upper respiratory tract (HCD).
The pathological-anatomical examination showed a infiltration of lung tissue particles of the substance tested. The measured particle size of the substance tested for acute inhalation are one order of magnitude smaller than the dimensions determined for the registered substance.
Reference
Observations during the exposure:
Immediately after application the animals were removed from tubes, placed in breeding containers and observed.
Motor disorders on the body,irregular breathing were recorded.
- 60 min after application:
animals presented the same symptoms of intoxication of the first observation
- 120 min after application:
animals presented the same symptoms of previous observations
- 2 days after application:
shaggy skins, different parts of the body covered by residues of the test substance,blue urine and swollen eyelids.
- 3 days after application:
in addition to the blue color of the urine were not check for any effects .
- 4 days: apart from slight blue discoloration of urine were no clinical signs of intoxication.
- From 5 to 14 days after application: during this period there were no clinical signs of intoxication.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 000 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for selection of acute toxicity – oral endpoint
Both studies are in agreement and with good reliability. The study conducted following the most updated OECD (420) has been selected as key study
Justification for classification or non-classification
According to the CLP Regulation (EC n. 1272/2008), table 3.1.1, Acute toxicity hazard categories and acute toxicity estimates (ATE) defining the respective categories:
For Acute toxicity oral route:
Category 1: ATE <= 5 mg/kg bw
Category 2: 5 < ATE <= 50 mg/kg bw
Category 3: 50 < ATE <= 300 mg/kg bw
Category 4: 300 < ATE <= 2000 mg/kg bw
The LD50 of the test substance was determined to be greater than 5000 mg/kg bw in the chosen reference test, which is outside the above criteria. Therefore, the test substance is not classified for Acute toxicity by oral exposure.
For Acute toxicity inhalation route (mists, mg/l)
Category 1: ATE <= 0.05
Category 2: 0.05 < ATE <= 0.5
Category 3: 0.5 < ATE <= 1
Category 4: 1 < ATE <= 5
The LC50 of the test substance was determined to be 5 mg/l, therefore, the test substance is not classified for Acute toxicity by inhalation exposure.
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