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EC number: 426-840-1 | 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Acclimatization: October 15, 1996 - Termination: November 05, 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- adopted February 24, 1987
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- July 31, 1992
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 426-840-1
- EC Name:
- -
- IUPAC Name:
- tetrasodium 7-[(2,6-difluoropyrimidin-4-yl)amino]-4-hydroxy-3-[2-(4-methoxy-2-sulfophenyl)diazen-1-yl]naphthalene-2-sulfonate 7-[(4,6-difluoropyrimidin-2-yl)amino]-4-hydroxy-3-[2-(4-methoxy-2-sulfophenyl)diazen-1-yl]naphthalene-2-sulfonate
- Test material form:
- solid
- Details on test material:
- Identity: Scarlet RN 1165
Appearance : Solid powder, dark-red
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanIbm: WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, 4414 Fullinsdorf I Switzerland
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation (age when treated): males 8 weeks, females 10 weeks
- Weight at study initiation (body weight range when treated): males 199.8-207.0 g, females 169.8-193.3 g
- Fasting period before study: overnight fasting period prior to application
- Housing: Groups of five in Makrolon type-4 cages with standard softwood bedding ("LignocelN, Schill AG, CH-4132 Muttenz).
- Diet (e.g. ad libitum): Pelleted standard Kliba 343, Batch no. 78/96 rat maintenance diet (Kliba MOhlen AG, CH-4303 Kaiseraugst) available ad libitum (except for the overnight fasting period prior to application). Results of analyses for contaminants are included in the report.
- Water (e.g. ad libitum):Community tap water from Itingen, available ad libitum. Results of bacteriological, chemical and contaminant analyses are included in the report.
- Acclimation period:One week under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): between 40-70% (values above 70% during cleaning process possible)
- Air changes (per hr): Air-conditioned with 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark, music during the light period
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- bi-distilled water
- Details on oral exposure:
- VEHICLE: bi-distilled water
- Concentration in vehicle: 0.2g test item/ml vehicle
- Amount of vehicle (if gavage): 10 ml vehicle/kg bw
- Justification for choice of vehicle: not detailed
- Lot/batch no. (if required): not detailed
- Purity: not detailed
MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg body weight
DOSAGE PREPARATION (if unusual):
The test article was placed into a glass beaker on a tared Mettler PM 460 balance and the vehicle (bi-distilled water) was added. A weight by volume dilution was prepared using a glass rod and a magnetic stirrer (Janke & Kunkel,
0-79219 Staufen) as homogenizers. Homogeneity of the test article in the vehicle was maintained during treatment using the same magnetic stirrer (Janke & Kunkel, 0-79219 Staufen). The preparation was made shortly before dosing.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: limit concentration of 2000 mg/kg bw
TREATMENT
The animals received a single dose of the test article on a mg/kg body weight basis by oral gavage following fasting for approximately 18 hours, but with free access to water. Food was provided again approximately 3 hours after dosing. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
MORTALITY/VIABILITY: four times during test day 1 and once daily for surviving animals during days 2-15.
CLINICAL SIGNS: each animal was examined for changes in appearance and behaviour four times during day l, and once daily for surviving animals during days 2-15. All abnormalities were recorded.
BODY WEIGHTS: on test day 1 (pre-administration), 8 and 15 for surviving animals.
- Necropsy of survivors performed: yes
Necropsies were performed by experienced prosectors. At the end of the observation period all animals were sacrificed by intraperitoneal injection of NARCOREN (Rhone Merieux GmbH, D-88471 Laupheim) at a dose of at least 2.0 ml/kg body weight (equivalent to at least 320 mg sodium pentobarbitone/kg body weight). The animals were examined macroscopically. Thereafter, they were discarded.
- Other examinations performed: - - Statistics:
- The LOGIT-Model could not be used as no deaths occured.
Results and discussion
- Preliminary study:
- Not performed.
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- No clinical signs of toxicity were observed during the study period.
- Body weight:
- The body weight of the animals was within the range of physiological variability known for rats of this strain and age.
- Gross pathology:
- No macroscopic findings were observed at necropsy.
Any other information on results incl. tables
Evolution of body weight (in grams):
Sex/dose |
Animal No. |
Day 1 (= day of treatment) |
Day 8 |
Day 15 |
Male / 2000 mg/kg |
1 |
204.6 |
272.1 |
305.3 |
2 |
207.0 |
265.1 |
278.6 |
|
3 |
201.9 |
253.3 |
277.0 |
|
4 |
199.8 |
260.7 |
286.1 |
|
5 |
200.2 |
253.9 |
286.1 |
|
Female/ 2000 mg/kg |
6 |
193.1 |
221.1 |
232.2 |
7 |
189.5 |
209.4 |
215.4 |
|
8 |
169.8 |
192.5 |
209.2 |
|
9 |
186.6 |
215.4 |
222.8 |
|
10 |
193.3 |
232.9 |
238.7 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The mean lethal dose of SCARLET RN 1165 after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated because LD50: greater than 2000 mg/kg.
- Executive summary:
A group of five male and 5 female Han!bm:WIST (SPF) rats was treated with SCARLET RN 1165 at 2000 mg/kg by oral gavage. The test article was suspended in vehicle (bi-distilled water) at a concentration of 0.2 g/ml and administered at a volume of 10 ml/kg. Four times during day 1 and once daily during days 2-15 the animals were examined for clinical signs. Mortality/viability were recorded together with clinical signs at the same time intervals. Body weights were recorded on day 1 before administration and on days 8 and 15. All animals were necropsied and examined macroscopically.
No deaths occurred during the study.
No clinical signs of toxicity were observed during the observation period.
The body weight of the animals was within the range of physiological variability known for rats of this strain and age.
No macroscopic findings were observed at necropsy.
CONCLUSION
The mean lethal dose of SCARLET RN 1165 after single oral administration to rats of both sexes, observed over a period of 14 days, could not be estimated, because LD50: greater than 2000 mg/kg
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