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EC number: 237-600-9 | CAS number: 13863-31-5
- 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
Specific investigations: other studies
Administrative data
- Endpoint:
- methaemoglobinaemia
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 18 to 19, 1981.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Test procedures cannot be subsumed under a testing guideline, nevertheless are well documented and scientifically acceptable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
- GLP compliance:
- no
- Type of method:
- in vivo
- Endpoint addressed:
- acute toxicity: oral
Test material
- Reference substance name:
- Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
- EC Number:
- 237-600-9
- EC Name:
- Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate
- Cas Number:
- 13863-31-5
- Molecular formula:
- C38H40N12Na2O8S2
- IUPAC Name:
- disodium 2,2'-ethene-1,2-diylbis[5-({4-anilino-6-[(2-hydroxyethyl)(methyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAIf
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: test laboratory.
- Age at study initiation: young adult rats, age not specified.
- Weight at study initiation: 180 - 250 g.
- Fasting period before study: overnight.
- Housing: two in Macrolon Cages, Type 3 with wire mesh tops and saw dust bedding (granular form).
- Diet : ad libitum, Rat chow N. 890 (NAFAG, Gossau SG).
- Water: ad libitum.
- Acclimation period: ad least 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 14/10 hrs dark / hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS
The test substance was dissolved in tap water in order to achieve a dosage level of 20 ml/kg body weight.
Prior to the administration the formulation was homogeneously dispersed with an Ultra-Turrax and subsequently placed on a magnetic stirrer.
- Analytical verification of doses or concentrations:
- not specified
- Frequency of treatment:
- Once.
- Post exposure period:
- 24 hours.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 8 animals in control group.
4 animals in the treated group and in the positive control group. - Control animals:
- yes, concurrent vehicle
Examinations
- Examinations:
- CLINICAL SIGNS and MORTALITY
Symptoms and mortality were assessed 1, 2, 4, 6 and 24 hours after the administration.
BLOOD SAMPLING
Blood was collected by puncture of the retroorbital plexus using heparinized micro-haematocrit tubes at the following times:
- prior to the administration (all animals);
- 15, 30, 60, 90 minutes, 2, 4, 6 and 24 hours (each time half group).
The blood samples were immediately cooled and the haematological investigation was performed without delay. - Positive control:
- The identical test was performed with a positive control group which received 40 mg/kg sodium nitrite solved in tap water, administered at a rate of 20 ml/kg.
Results and discussion
- Details on results:
- SYMPTOMS
Sedation, dyspnea, ruffled fur, diarrhea and curved body position were observed.
MORTALITY
No animal died during the test period.
METHAEMOGLOBIN-induction
The individual and mean values of the Methaemoglobin determinations are listed in Table 2 - 4.
Any other information on results incl. tables
Statistical Analysis of Methaemoglobin values
Generally the mean values of the test group are inferior to the ones of the negative control group with the exception of the samples taken after 15 min., 90 min. and 6 hours.
As the overall mean of the negative control group is superior to the one of the test group, no significant increase of Methaemoglobin can be demonstrated.
Table 1A: Symptoms observed in the negative control group
Symptoms | Observation time after administration (hours) | ||||
1 | 2 | 4 | 6 | 24 | |
ruffled fur | + |
Table 1B: Symptoms observed in the test group
Symptoms | Observation time after administration (hours) | ||||
1 | 2 | 4 | 6 | 24 | |
sedation | + | + | + | + | + |
dyspnea | + | + | + | ||
ruffled fur | + | + | + | + | + |
diarrhea | + | + | |||
curved body position | + | + | + | + |
Table 1C: Symptoms observed in the postive control group
Symptoms | Observation time after administration (hours) | ||||
1 | 2 | 4 | 6 | 24 | |
sedation | ++ | ++ | + | + | + |
dyspnea | + | + | + | + | + |
ruffled fur | ++ | ++ | ++ | ++ | ++ |
curved body position | + | + | + | + | + |
key: + = slight, ++ = moderate, +++ = severe
Table 2: Methaemoglobin levels in negative control group:
Time | animals (n) | mean | standard deviation |
pretest | 16 | 0.65 | 0.186 |
15 min | 8 | 0.638 | 0.25 |
30 min | 7 | 0.542 | 0.181 |
60 min | 8 | 0.738 | 0.288 |
90 min | 8 | 0.638 | 0.192 |
2 h | 8 | 0.675 | 0.149 |
4 h | 8 | 1.038 | 0.297 |
6 h | 8 | 0.925 | 0.324 |
24 h | 8 | 1.2 | 0.428 |
Table 3: Methaemoglobin levels in test group:
Time | animals (n) | mean | standard deviation |
pretest | 8 | 0.538 | 0.262 |
15 min | 4 | 0.7 | 0.432 |
30 min | 4 | 0.475 | 0.359 |
60 min | 4 | 0.55 | 0.412 |
90 min | 4 | 1.075 | 0.299 |
2 h | 4 | 0.5 | 0.258 |
4 h | 4 | 0.7 | 0.837 |
6 h | 4 | 1.225 | 0.506 |
24 h | 4 | 0.75 | 0.342 |
Table 4: Methaemoglobin levels in positive control group:
Time | animals (n) | mean | standard deviation |
pretest | 8 | 0.7 | 0.2 |
15 min | 4 | 17.8 | 3.2 |
30 min | 4 | 19.8 | 12.1 |
60 min | 3 | 30.6 | 6.1 |
90 min | 4 | 23.2 | 16.9 |
2 h | 4 | 24.4 | 13.6 |
4 h | 4 | 4.1 | 4.9 |
6 h | 4 | 0.8 | 0.4 |
24 h | 4 | 1 | 0.6 |
Applicant's summary and conclusion
- Conclusions:
- The test substance has been found to be devoid of Methaemoglobin-inducing capacity after single oral administration of 5000 mg/kg in young adult rats.
- Executive summary:
Method
The purpose of the study was evaluate the Methaemoglobin-inducing capacity of the test substance in comparison with a negative control.
Results
The test substance has been found to be devoid of Methaemoglobin-inducing capacity after single oral administration of 5000 mg/kg in young adult rats.
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