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EC number: 600-519-8 | CAS number: 1040873-93-5
- 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
In an acute oral toxicity study in rats the acute oral LD50 was determined to be > 2000 mg dye/kg bw (corresponding to > 2300 mg product/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:
- 07 December 2016 - 16 March 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI rats
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Source: TOXI COOP ZRT. Cserkesz u. 90., 1103 Budapest, Hungary
Hygienic level at arrival: SPF
Hygienic level during the study: Good conventional
Justification of strain: The Wistar rats as a rodent is one of the standard species of acute toxicity studies
Number of animals: 3 animals/group
Sex: Female, nulliparous and non pregnant animals
Age of animals: Young adult rat, 8 weeks old in first and second step
Body weight range at starting (first step): 218 - 224 g
Body weight range at starting (second step): 216 - 218 g
Acclimatization time: 6 days in the first step and 7 days in the second step
Husbandry
Animal health: Only healthy animals were used for the study. Health status was certified by the study director.
Room: 13/2
Housing: Group caging (3 animals/cage)
Cage type: Type II polypropylene/polycarbonate.
Bedding: Laboratory bedding.
Light: 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Temperature: 22 ± 3 °C
Relative humidity: 30 - 70 %
Ventilation: above 10 air exchanges/hour by central air-condition system.
The temperature and relative humidity were recorded daily during the study.
Food and Water Supply
Animals received ssniff® SM R/M-Z+H complete diet for rats and mice produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany and tap water from municipal supply, as for human consumption from bottle ad libitum.
The diet and drinking water are periodically analysed and are considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- All doses were formulated in the vehicle. Concentration of formulations was adjusted to maintain a treatment volume of 10 mL/kg bw. The test item was applied in a concentration of 200 mg/mL. The correction factor (1.15) was taken into consideration in the course of the preparation of solution. Formulations were prepared just before the administration and were stirred continuously during the treatment.
Vehicle
Name: Aqua purificata Ph.Hg. VIII.
Batch number: 1608-5511
Date of expiration: 11.02.2017
Produced by: Parma Produkt Kft. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 animals/group
- Control animals:
- no
- Details on study design:
- A single oral administration - followed by a fourteen-day observation period - was performed by gavage. The day before treatment the animals were fasted. The food but not water was withheld overnight. Animals were weighed before the application and the food was given back 3 hours after the treatment.
Duration of the experimental period
6 days in the first step and 7 days in the second step of acclimatization, treatment’s day, 14 days post-treatment observation period and necropsy on Day 15.
Mortality
Animals were observed individually after dosing at least once during the first 30 minutes, then 1 h, 2 h, 3 h, 4 h after the treatment and twice each day for 14 days thereafter.
General state, external appearance, behavior and clinical symptoms
Individual observations were performed on the skin and fur, eyes and mucous membranes and also respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Body weight
The body weights were recorded on day 0 (just before the treatment), on day 7 and on day 15 with a precision of 1 g.
Necropsy
At the end of the observation period all surviving rats were sacrificed under isofluran anaesthesia. After examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed, and any abnormality was recorded with details of its location, colour, shape and size. - Statistics:
- The method used is not intended to allow statistical evaluation and the calculation of a precise LD50 value.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- act. ingr.
- Mortality:
- No lethality was noted at a single oral dose of 2000 mg/kg bw.
- Clinical signs:
- In the first and second step, no clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behaviour of experimental animals were normal.
- Body weight:
- The body weight development was undisturbed in all animals.
- Gross pathology:
- All organs of the animals treated with 2000 mg/kg bw proved to be free of treatment related gross pathological changes.
- Other findings:
- No death occurred after the single 2000 mg/kg bw oral dose of the test item. There were no toxic clinical signs or any treatment related effects of the test item found in body weights and body weight gains during the study. Autopsy revealed no treatment related pathological changes.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The oral LD50 was determined to be > 2000 mg dye/kg bw (corresponding to > 2300 mg product/kg bw).
- Executive summary:
An acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. The dose refers to the dye content (87 %, correction factor of 1.15) and corresponds to 2300 mg product/kg bw. No animal died in the first step at 2000 mg/kg bw dose level, so treatment with 2000 mg/kg bw was repeated on further three female rats. No animal died in the second step, too, so the test was finished, the stopping criteria of Annex 2d of OECD Guideline No. 423 was met. Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on the 15th day after the treatment. No lethality was noted at a single oral dose of 2000 mg/kg bw. In the first and second step, no clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behaviour of experimental animals were normal. The body weight development was undisturbed in all animals. All organs of the animals treated with 2000 mg/kg bw proved to be free of treatment related gross pathologicakem changes. The method used is not intended to allow the calculation of a precise LD50 value. The oral LD50 was determined to be > 2000 mg/kg bw.
Reference
Table 1: Summary of Clinical Symptoms
Groups |
Treatment |
Symptoms |
Incidence |
|
Test Item |
Dose |
|||
1 |
Blue Sema |
2000 |
Normal |
57/57 |
2 |
Blue Sema |
2000 |
Normal |
57/57 |
Table 2: Summary of Body Weights (g)
|
Day 0 |
Day 7 |
Day 15 |
|
|
|
|
|
|
Group 1: |
||||
2000 mg/kg bw, Step 1 |
|
|
|
|
|
|
|
|
|
Group size: |
|
3 |
3 |
3 |
Mean: (g) |
|
221.0 |
248.7 |
261.7 |
SD: |
|
3.00 |
6.66 |
6.35 |
|
|
|
|
|
|
Day 0 |
Day 7 |
Day 15 |
|
|
|
|
|
|
Group 2: |
||||
2000 mg/kg bw, Step 2 |
|
|
|
|
|
|
|
|
|
Group size: |
|
3 |
3 |
3 |
Mean: (g) |
|
216.7 |
237.0 |
248.7 |
SD: |
|
1.15 |
10.00 |
9.07 |
|
|
|
|
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute oral toxicity:
An acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. The dose refers to the dye content (87 %, correction factor of 1.15) and corresponds to 2300 mg product/kg bw. No animal died in the first step at 2000 mg/kg bw dose level, so treatment with 2000 mg/kg bw was repeated on further three female rats. No animal died in the second step, too, so the test was finished, the stopping criteria of Annex 2d of OECD Guideline No. 423 was met. Animals were weighed, observed for lethality and toxic symptoms for 14 days after the treatment. Gross pathological examination was carried out on the 15th day after the treatment. No lethality was noted at a single oral dose of 2000 mg/kg bw. In the first and second step, no clinical symptoms were observed on the day of the treatment and during the 14-day observation period, the general state and behaviour of experimental animals were normal. The body weight development was undisturbed in all animals. All organs of the animals treated with 2000 mg/kg bw proved to be free of treatment related gross pathologicakem changes. The method used is not intended to allow the calculation of a precise LD50 value. The oral LD50 was determined to be > 2000 mg/kg bw.
Acute inhalation toxicity:
The study does not need to be conducted as exposure of humans via inhalation is not the appropriate route of exposure. Furthermore, physicochemical and toxicological properties do not suggest a potential for a significant rate of respiratory absorption.
Acute dermal toxicity:
According to REACH Annex VIII point 8.5.3 the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).
Justification for classification or non-classification
Classification, Labelling, and Packaging
Regulation (EC) No 1272/2008
The available experimental test
data are reliable and suitable for classification purposes under
Regulation (EC) No 1272/2008. Based on available data on acute oral
toxicity, the test item is not classified according to Regulation (EC)
No 1272/2008 (CLP), as amended for the twelfth time in Regulation (EU)
No 2019/521.
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