Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 229-851-8 | CAS number: 6786-83-0 with ≥ 0.1% of Michler's ketone (EC No. 202-027-5) or Michler's base (EC No. 202-959-2)
- 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
- 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
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
Materials and methods
Test guideline
- Qualifier:
- according to
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- The aim of this study was to assess the toxicity potential of α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol (containing less than 0.1% Michler’s Ketone) Synonym Solvent Blue 4 (CAS No. – 6786-83-0) after single oral administration in rats and an observation period of 14 days.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report):α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol (containing less than 0.1% Michler’s Ketone) Synonym Solvent Blue 4
- Substance type:Organic
-Purity:99.02%
- Storage condition of test material:Stored in cool, dry place. Kept in closed container when not in use.
- Other:
Handling and Disposal
Safety precautions: Avoided eye and skin contact. Avoided inhalation and spilling. Aprons, caps, mask, gloves and goggles were used to ensure the health and safety of the personnel.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation:8- 10 weeks at the time of dosing.
- Health Status :Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Weight at study initiation:Minimum: 131 g Maximum: 160 g (Individual body weights were within ± 7% prior to treatment after overnight fasting)
- Fasting period:were fasted for 16 to 18 hours, prior to dosing .
- Housing:The animals were housed individually in polycarbonate cages.
- Bedding:All cages were provided with corn cobs (Sparconn Life Sciences Bangalore) Batch No.: SPAR – 25/2014.
- Room Sanitation:The experimental room floor and work tops were swept and mopped with disinfectant solution every day.
- Cages and water bottle:All the cages and water bottles were changed at least twice every week.
- Diet (e.g. ad libitum):All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune) ad libitum. Batch No 400004..
- Water (e.g. ad libitum):Aqua guard filtered tap water was provided ad libitum via drinking bottles
- Acclimation period:Animal nos. 1-3 were acclimatized for 5 days and 4-6 for 11 days prior to administration of the test item..
ENVIRONMENTAL CONDITIONS
-Temperature : Minimum: 19.80°C Maximum: 23.20°C
-Relative humidity:Minimum: 48.70 % Maximum: 69.20 %
-Light-dark-rhythm:12:12
-Air Changes : More than 12 changes per hour
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: distilled water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage):10 ml
- Justification for choice of vehicle:N/A
- Lot/batch no. (if required):N/A
- Purity:N/A
MAXIMUM DOSE VOLUME APPLIED:10 ml/kg body weight. - Doses:
- G1 = 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 female rats
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Daily
- Necropsy of survivors performed: yes
AAt the end of 14 day observation period, all surviving rats were euthanised by overdose of CO2 for external and internal observations.
- Other examinations performed:
Clinical Observation
After test item administration, individual animals were frequently observed at 30 minutes, 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all the six animals were observed once a day during the 14 day observation period.
Mortality
All the animals were observed twice daily (morning and evening) for morbidity and mortality, throughout the acclimatization and study period.
Body weight
All the rats were weighed on days 0 (prior to dosing), 7 and 14. Animals were weighed immediately after found dead.
Pathology
At the end of 14 day observation period, all surviving rats were euthanised by overdose of CO2 for external and internal observations
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed througout the experimentation period
- Clinical signs:
- At 2000mg/kg, animal no. 1 and 4 were observed with mild lethargy at 30 minutes, 1, 2, 3, 4 hours and on day 1 post dosing while additionally, animal no. 1 was observed with mild lethargy on day 2 and animal no. 4 was observed with mild diarrhea at 1 and 2 hours, followed by normal clinical signs till day 14. Animal no. 2 was observed with normal clinical signs at 30 minutes, mild lethargy at 1, 2, 3 and 4 hours and mild diarrhoea at 1 and 2 hours, followed by normal clinical signs till day 14. Animal no. 3 was observed with mild lethargy at 30 minutes, 1, 2, 3, 4 hours, day 1, 2 and 3 and mild diarrhoea at 2 hours, followed by normal clinical signs till day 14. Animal no. 5 was observed with mild lethargy at 30 minutes, 1, 2, 3 and 4 hours and mild diarrhoea at 1, 2, 3 and 4 hours, followed by normal clinical signs till day 14. Animal no. 6 was observed normal clinical signs at 30 minutes, 1, 2, 3 and 4 hours and mild lethargy on day 1 and 2, followed by normal clinical signs till day 14
- Body weight:
- Mean body weight of animals treated with 2000 mg/kg body weight was observed with gain on day 7 and 14, as compared to day 0
- Gross pathology:
- No external and internal gross pathological examination were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice
Any other information on results incl. tables
Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)
Sex:Female
Animal No. | Group/ Dose (mg/kg) | Body Weight (gram) | Body Weight Change (%) | |||
Day 0 | Day 7 | Day 14 | Day 0-7 | Day 0-14 | ||
1 | G1/ 2000 | 135 | 160 | 177 | 18.52 | 31.11 |
2 | 146 | 180 | 199 | 23.29 | 36.30 | |
3 | 137 | 143 | 172 | 4.38 | 25.55 | |
4 | 147 | 166 | 182 | 12.93 | 23.81 | |
5 | 160 | 190 | 206 | 18.75 | 28.75 | |
6 | 131 | 161 | 183 | 22.90 | 39.69 |
Key:- = Not Applicable
Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)
Sex:Female
Group/ Dose (mg/kg) | Rats Body Weight (g) | Body Weight Changes (%) | ||||
Day 0 | Day 7 | Day 14 | 0-7 | 0-14 | ||
G1/ 2000 | Mean | 142.67 | 166.67 | 186.50 | 16.79 | 30.87 |
SD | 10.56 | 16.49 | 13.19 | 7.15 | 6.17 | |
n | 6 | 6 | 6 | 6 | 6 |
Keys:- = Not applicable, 1 = Normal, 2 = Found dead, 4 = Abdominal breathing, 145 = Salivation, 155 = Sternal recumbency, 166 = Tremors, + = Mild, ++ = Moderate
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 (cut-off value) of Solvent blue 4 (CAS No. – 6786-83-0) was greater than 2000 mg/kg body weight.Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that Solvent blue 4 (CAS No.- 6786-83-0) does not exhibits acute oral toxicity in as per CLP criteria of classification
- Executive summary:
Acute Oral Toxicity Study ofSolvent blue 4 (CAS No. – 6786-83-0)in Rats, This study was performed as per OECD No. 423.
Six female Wistar rats were selected for acute oral toxicity study. The animals were fasted for minimum 16-18 hours prior to dosing and for 4 hours post dosing, with food withheld but drinking water providedad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs. Three rats of group G1 were dosed with starting dose of 2000 mg/kg body weight and the animals showed no mortality post dosing, so another three rats of the same group were dosed with 2000 mg/kg weight and no mortality was observed. Hence, further dosing was stopped. Body weights were recorded on day 0 (prior to dosing) 7 and 14. Mean body weight of all six animals was observed with gain on day 7 and 14, as compared to day 0. At 2000mg/kg, animal no. 1 and 4 were observed with mild lethargy at 30 minutes, 1, 2, 3, 4 hours and on day 1 post dosing while additionally, animal no. 1 was observed with mild lethargy on day 2 and animal no. 4 was observed with mild diarrhea at 1 and 2 hours, followed by normal clinical signs till day 14. Animal no. 2 was observed with normal clinical signs at 30 minutes, mild lethargy at 1, 2, 3 and 4 hours and mild diarrhoea at 1 and 2 hours, followed by normal clinical signs till day 14. Animal no. 3 was observed with mild lethargy at 30 minutes, 1, 2, 3, 4 hours, day 1, 2 and 3 and mild diarrhoea at 2 hours, followed by normal clinical signs till day 14. Animal no. 5 was observed with mild lethargy at 30 minutes, 1, 2, 3 and 4 hours and mild diarrhoea at 1, 2, 3 and 4 hours, followed by normal clinical signs till day 14. Animal no. 6 was observed normal clinical signs at 30 minutes, 1, 2, 3 and 4 hours and mild lethargy on day 1 and 2, followed by normal clinical signs till day 14
No external and internal gross pathological examination were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifceUnder the conditions of this; acute oral toxicity study of Solvent blue 4 (CAS No. – 6786-83-0) in female rats is as given below:The acute oralLD50(Cut-off value) of Solvent blue 4 (CAS No. – 6786-83-0)was greater than 2000 mg/kgbody weight
Solvent blue 4 (CAS No. – 6786-83-0) isbeing not classified as per CLP regulation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

Route: .live2