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EC number: 281-589-3 | CAS number: 83969-12-4
- 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
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- 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
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
- Biodegradation
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- 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:
- 02 Nov -13 Dec 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium methyl sulphate
- EC Number:
- 281-589-3
- EC Name:
- 5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium methyl sulphate
- Cas Number:
- 83969-12-4
- Molecular formula:
- C17H27N6S.CH3O4S
- IUPAC Name:
- 4-{2-[(2E)-5-[bis(propan-2-yl)amino]-3-methyl-2,3-dihydro-1,3,4-thiadiazol-2-ylidene]hydrazin-1-ylidene}-N,N-dimethylcyclohexa-2,5-dien-1-iminium methyl sulfate
- Test material form:
- liquid
- Details on test material:
- Basic Blue 159 methyl sulfate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 9 wks (male), 14 wks (female)
- Weight at study initiation: mean 181 g (male), 176 g (female)
- Fasting period before study: 16 h
- Housing: Makrolon Type III cages (group of 5 animals)
- Diet (e.g. ad libitum): ad lib.
- Water (e.g. ad libitum): ad lib.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 40 - 60 rh
- Light/darkness (h): 12/12
- Acclimation period: min. 5 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Application volume: 10 mL/kg bw
- Doses:
- males: 50, 100, 200, 250, 500, 800 mg/kg bw
females: 50, 100, 200, 250, 310 mg/kg bw - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily
- Other examinations performed: clinical signs, body weight, gross pathology - Statistics:
- Probit analysis
Results and discussion
- Preliminary study:
- Probit analysis
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 216 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 172 - 272
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 124 mg/kg bw
- Based on:
- act. ingr.
- 95% CL:
- 99 - 156
- Mortality:
- 50 mg/kg bw: no mortality
100 mg/kg bw: 0-20%
200 mg/kg bw: 20%
250 mg/kg bw: 80%
310 (female) & 800 (male) mg/kg bw: 100%
Mortality occurred between 1h - 1d after application - Clinical signs:
- 50 mg/kg bw: no symptoms
100 - 800 mg/kg bw: bad general condition, sedation, prone or later position, bristled fur
200 -800 mg/kg bw: algospams
310 / 800 mg/kg bw: gasping
All symptoms occurred ca. 30 min after application and disappeared until day 2. - Body weight:
- Males: no influence
Females: slight growth inhibition from 200 mg/kg bw - Gross pathology:
- 100 - 800 mg/kg bw: stomach mucosa elapsed, stomach/gut contents reddened and bloated
250 - 800 mg/kg bw: lungs reddened
All survivors from 50 - 500 mg/kg bw were pathologically w/o finding
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The LD50 (oral, gavage) in male and female rats was determined to be 124 mg/kg bw. The substance is classified as Category 3.
- Executive summary:
An acute oral toxicity study was carried out with the test item in male and female rats. Five rats/sex/dose groups received a single gavage of the test item dissolved in distilled water at dose levels of 50, 100, 200, 250, 500, 800 mg/kg bw for males and 50, 100, 200, 250, 310 mg/kg bw for females. The animals were observed for signs of toxicity for 14 days thereafter.
Clinical signs observed in animals after a single administration of 100 to 800 mg/kg bw Basic Blue 159 were poor general condition, piloerection, sedation and prone or lateral position. Occasionally, tonic-clonic convulsions, laboured respiration and stilted gait occurred. A slight delay in body weight development was observed in females at a dose of 200 mg/kg bw in the first week of the study. In the pathological-anatomical examination of the deceased male and female rats at doses of 100 to 800 mg/kg bw, non-specific damage to the gastrointestinal tract and in part reddening of the lungs were observed. A dose of 50 mg/kg was tolerated without any clinical signs.
The following deaths were observed during the post-treatment phase:
Dose [mg/kg bw]
No of deaths
Time of death
Mortality rate [%]
males
50
0
-
0
100
0
-
0
200
1
4 h
20
250
4
4-8 h
80
500
4
1 h
80
800
5
2-4 h
100
females
50
0
-
0
100
1
1 h
20
200
1
1 d
20
250
4
4-8 h
80
310
5
4-8 h
100
The resulting oral LD50 for males and females together was calculated to be 216 mg/kg bw (CI 172 to 272 mg/kg bw) based on test material. This calculated to 124 mg/kg bw for the active ingredient.
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