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EC number: 229-851-8 | CAS number: 6786-83-0
- 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
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- Endpoint summary
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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
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
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- 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

Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Conclusions drawn from a GLP experimental study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
- Principles of method if other than guideline:
- Effects on male and female reproductive organs were studies in the 28 day repeated oral toxicity study
- GLP compliance:
- no
- Remarks:
- Deviation in test compared to the GLP guidelines for reproductive toxicity study
- Limit test:
- no
Test material
- Reference substance name:
- α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol
- EC Number:
- 229-851-8
- EC Name:
- α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol
- Cas Number:
- 6786-83-0
- Molecular formula:
- C33H33N3O
- IUPAC Name:
- (4-anilino-1-naphthyl){bis[4-(dimethylamino)phenyl]}methanol
- Reference substance name:
- Solvent Blue 4 with less than 0.1% Michler's Ketone
- IUPAC Name:
- Solvent Blue 4 with less than 0.1% Michler's Ketone
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- IUPAC name of the chemical: α,α-Bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-methanol (C.I. Solvent Blue 4) [with < 0.1% of Michler's ketone
CAS Name: Solvent Blue 4 with less than 0.1% Michler's Ketone
CAS No: 6786-83-0
Nature of chemical: Organic
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Central Animal Facility (CAF), NIPER, Sector-67, S.A.S. Nagar, 160 062, Punjab, India.
- Age at study initiation: (P) x wks; (F1) x wks:
( P) 7 to 8 weeks old
- Weight at study initiation: (P) Males: x-x g; Females: x-x g: Male 196.26 - 241.83 g,
Female 182.80-213.04 g
(F1) Males: x-x g; Females: x-x g: No data available
- Fasting period before study: A fast of 2h before chemical administered.
- Housing: Animals were housed four rats per sex per cage in sterilized solid bottom polypropylene cages with stainless steel grill tops with facilities for food, water bottles and bedding of clean paddy husk. The cages were suspended on stainless steel racks. Identified by assigned a unique identification (ID) number written on the tail, also specified on individual cage tag.
- Diet (e.g. ad libitum): Standard laboratory sterile extruded pelleted rodent feed, ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 25 ± 5 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark
- Water (e.g. ad libitum): Potable tap water filtered through Reviva Reverse Osmosis
System (water filter cum purifier) of Eureka Forbes was provided in polypropylene bottles with stainless steel sipper tubes, ad libitum.
- Acclimation period: 5 days
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Dose of the test item was freshly prepared prior to dosing on each day. The test item Solvent blue 4 (SBL) was administered to each rat at the dose levels of 50, 150 or 450 mg/kg in the dose volume of 10 ml/kg body weight. The test item was weighed on a weighing balance. Then, it was transferred to calibrated falcon tube. Some quantity of the corn oil was added initially and vortexed. The sufficient quantity of vehicle was added to make up the required volume of dose.
Justification for use and choice of vehicle (if other than water): Corn oil was used as a vehicle for this study as the test item was not soluble in water and to deliver the desired dose levels because it is also recommended in the toxicological evaluation guidelines.
- Concentration in vehicle: 0, 50, 150 or 450 mg/kg body weight /day
Amount of vehicle (if gavage): 10 ml/kg body weight
- Lot/batch no. (if required): No data available
- Purity: No data available - Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentration of the test item was calculated using the absorbance of the standard concentrations of the solvent blue.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 150 or 450 mg/kg/body weight/day
Basis:
nominal conc.
- No. of animals per sex per dose:
- Total : 56
0 mg/kg/body weight/day: 7 male, 7 female
50 mg/kg/body weight/day: 7 male, 7 female
150 mg/kg/body weight/day: 7 male, 7 female
450 mg/kg/body weight/day: 7 male, 7 female - Control animals:
- yes, concurrent no treatment
Examinations
- Parental animals: Observations and examinations:
- Mortality and changes in body weight of the male and female reproductive organs like the testis, epidydimydes, uterus and ovary respectively were noted. In addition, food consumption, water consumption and locomotor activity effects were also recorded.
In male rats, relative organ weight of brain was significantly increased while no changes were observed in female organ weight when treated with 50 mg/kg/body weight/day as compare to control. - Oestrous cyclicity (parental animals):
- No changes detected as compared to control when treated with 50 mg/kg/day.
- Sperm parameters (parental animals):
- No changes detected as compared to control when treated with 50 mg/kg/day.
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- Testes, ovaries and uterus were pathologically examined after termination. Examinations also included weight of brain, epididymides, and ovaries (incl. paired ovaries and uterus, including cervix).
- Postmortem examinations (offspring):
- No data available
- Statistics:
- Statistical analysis was carried out by using Microsoft Excel and IBM SPSS statistics version- 20.0. All analyses and comparisons were evaluated at the 5 % level, statistically significant differences (p ≤ 0.05) indicated by appropriate notation. The focus was to examine the mean differences and their significance in control vs low-dose group only as there was total mortality observed in mid and high-dose groups in both the sexes. The statistical decision was taken by preparing the univariant GLM MODEL to check the significance between above mentioned groups. For multiple comparisons Turkey’s HSD test was applied.
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 450 mg/kg/body weight/day, all the male and female were dead on day 5 as compare to control. When treated with 150 mg/kg/body weight/day, all the male and female were dead on day 11 as compare to control.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 50 mg/kg/body weight/day significant decrease in body weight was observed in treated male and female rat as compare to control.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 50 mg/kg/body weight/day significant decrease in body weight was observed in treated male and female rat as compare to control.
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- No significant changes were observed in the reproductive organs of 50 mg/kg/body weight/day treated male and female rat as compared to control.
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- effects observed, treatment-related
- Description (incidence and severity):
- No changes detected as compared to control when treated with 50 mg/kg/day.
- Reproductive function: sperm measures:
- effects observed, treatment-related
- Description (incidence and severity):
- No changes detected as compared to control when treated with 50 mg/kg/day.
- Reproductive performance:
- not specified
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: based on observations of reproductive organs like testes, ovaries and uterus that were pathologically examined after termination
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not specified
- Mortality / viability:
- not specified
- Body weight and weight changes:
- not specified
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
Details on results (F1)
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
Summary of Reproductive Organ Weights (Male Rats)
Group/Dose |
|
Testes |
Epididymides |
1/0 mg/kg bw |
Mean |
0.9930 |
0.4157 |
SD |
0.1199 |
0.0675 |
|
SEM |
0.0453 |
0.0255 |
|
2/50 mg/kg bw |
Mean |
1.0826 |
0.4780 |
SD |
0.1111 |
0.0530 |
|
SEM |
0.0420 |
0.0200 |
No significance attributed to the body weight changes in comparison to control groups
Summary of Reproductive Organ Weights (Female Rats)
Group/Dose |
|
Uterus |
Ovaries |
5/0 mg/kg bw |
Mean |
0.2915 |
0.0441 |
SD |
0.0519 |
0.0188 |
|
SEM |
0.0196 |
0.0071 |
|
6/50 mg/kg bw |
Mean |
0.2346 |
0.0412 |
SD |
0.0701 |
0.0155 |
|
SEM |
0.0265 |
0.0059 |
No significance attributed to the body weight changes in comparison to control groups
Applicant's summary and conclusion
- Conclusions:
- Male and female rats dosed with 50 mg/kg bw of Solvent blue 4 did not show appreciable difference in the weight of testes & epidydimides and uterus and ovaries respectively, as compared to the control. No significance attributed to the reproductive organ body weight changes in comparison to control groups.
Hence the no observed adverse effect level (NOAEL) for the parents has been concluded to be 50 mg/kg bw - Executive summary:
In a 28 days repeated dose toxicity study, the effect on the reproductive organs of Solvent blue 4 (containing less than 0.1% Michler's Ketone) was evaluated in male and female Sprague Dawley rats. The test chemical was administered by oral gavage in the concentration of 0,50, 150 or 450 mg/kg body weight/day. The results showed that Solvent blue 4in treated rats had nasal discharge, red crust around nostrils and soft feces and vocalization on handling, and decreased body weight were also observed as compare to control. In male rat, there were increased levels of RBC, monocytes, potassium and total protein, while female rats showed decreased level of total bile acid as compare to control.
Histopathology showed no significant changes at treatment with 50 mg/kg/body weight/day as compare to control. In addition, male and female rats dosed with 50 mg/kg body weight of Solvent blue 4 did not show appreciable difference in the weight of testes and epidydimides or in uterus and ovaries as compared to the control. Therefore, NOAEL is considered to be 50 mg/kg/day when male and female Sprague Dawley rats were exposed daily toSolvent blue 4 by oral route for 28 days.
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