Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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: 221-831-7 | CAS number: 3248-91-7
- 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
Endpoint summary
Administrative data
Description of key information
Repeated dose oral toxicity study was performed to determine the oral toxic nature of Basic Violet 2 upon repeated exposure for 13 weeks to rats (SCCS, 2011). The test chemical dissolved in water as vehicle at dose levels of 3, 10 or 30 mg/kg bw/day was administered by the gavage route to 10 male and 10 female Sprague Dawley Hsd: SD strain rats for 13 weeks. The animals were observed for mortality, clinical signs, ophthalmology, neurotoxicity, body weight and organ weight changes, food intake, hematological and clinical chemistry changes. Staining of the faeces in all test groups. Occasional hunched posture and dyspnoea in a few 30 mg/kg bw/day rats was noted. On day 57, 2 females from the 30 mg/Kg bw/day died due to misdosing. Females of the 30 mg/Kg bw/day showed reduced body weight from day 8 of treatment.With regard to body weight a statistically significant reduction was observed in females at 30 mg/kg/bw and at 10 mg/kg bw/d also a reduction was noted. In males only a slight reduction was observed at 30 mg/kg/bw. This was accompanied by reduced body weight gains in all these groups. In females at 30 mg/kg/bw also food consumption was reduced. Food intake was lowered in the 30 mg/Kg bw/day females in the last week. Dose related effects were noted in the hematological parameters.Haematological observations were reduction in red blood cells counts in both males and females which were statistically significant at 10 and 30 mg/kg bw/d for males and at 30 mg/kg bw/d for females. Furthermore, haematocrit values were slightly reduced in all dose groups in females. Further, the values for mean corpuscular haemoglobin (MCH) and mean corpuscular volume (MCV) were slightly increased in males and females of all dose groups. However, all changes were in the range of the historical controls.Dose related effects were noted in the clinical parameters.Some differences were observed with regard to Na, Ca, K, glucose, cholesterol as well as in the levels of alkaline phosphatase and aspartate aminotransferase. It was argued that all values were well within the range of historical controls. Relative organ weights were statistically significantly increased in x males and females at 30 m/kg bw/d for liver, kidneys and heart, the latter being additionally elevated (statistically significant) in males at 10 mg/kg bw/d. In addition, at 30 mg/kg bw slight increases were observed in relative testes weights in males and relative brain weights in females (both statistically significant). Despite the results of the statistical analyses of differences to controls, the differences were slight and all mean values remained well within the range of historical control data. The only organ in which a histopathological correlate was observed was the liver (centrilobular hepatocytic hypertrophy in five 10 mg/Kg bw/day males and in most high-dose males and females. Hepatocytic necrosis in one 30 mg/Kg bw/day male). Dark and firm areas in the liver in three 30 mg/Kg bw/day males. Centrilobular hepatocytic hypertrophy in five 10 mg/Kg bw/day males and in most 30 mg/Kg bw/day males and females. Hepatocytic necrosis in one 30 mg/Kg bw/day male. Nephropathy (tubular basophilia / dilatation and /or chronic inflammation) in five 10 mg/Kg bw/day males and six 30 mg/kg bw/day males. At the doses 30 and/or 10 mg/kg bw/day histopathological findings in liver and kidney indicate organ toxicity which is supported by changes in body and organ weights as well as in biochemical parameters (cholesterol, aspartate aminotransferase, alkaline phosphatase). Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for the test compound Basic violet 2 is considered to be 3 mg/Kg bw/day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from SCCS report
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Repeated dose oral toxicity study was performed to determine the oral toxic nature of Basic Violet 2 upon repeated exposure for 13 weeks to rats
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material: New Fuchsin
- Molecular formula: C22H23N3ClH
- Molecular weight: 365.906 g/mol
- Substance type: Organic
- Physical state: No data
- Impurities (identity and concentrations): 6% - Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Hsd: SD
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: gavage
- Details on route of administration:
- No data
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The test chemical was dissolved in water to give the appropriate dose range of 0, 3, 10 or 30 mg/kg bw/day
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): Water
- Concentration in vehicle: 0, 3, 10 or 30 mg/kg bw/day
- Amount of vehicle (if gavage): 10 mL/Kg bw/day
- Lot/batch no. (if required): No data
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Once daily
- Remarks:
- 0, 3, 10 or 30 mg/kg bw/day
- No. of animals per sex per dose:
- Total: 40 males and 40 females
0 mg/kg bw: 10 males and 10 females
3 mg/kg bw: 10 males and 10 females
10 mg/kg bw: 10 males and 10 females
30 mg/kg bw: 10 males and 10 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. Mortality
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations: No data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. Hematocrit, RBC, MCH, MCV, hemoglobin
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. NA. Ca, K, Cholesterol, glucose, ASAT and ALP activity
URINALYSIS: No data
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
OTHER: Neurotoxicity was noted - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, relative kidney, heart and liver weight was measured
HISTOPATHOLOGY: Yes, histological examination was performed - Other examinations:
- No data
- Statistics:
- No data
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Staining of the faeces in all test groups. Occasional hunched posture and dyspnoea in a few 30 mg/kg bw/day rats was noted
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- On day 57, 2 females from the 30 mg/Kg bw/day died due to misdosing
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Females of the 30 mg/Kg bw/day showed reduced body weight from day 8 of treatment.
With regard to body weight a statistically significant reduction was observed in females at 30 mg/kg/bw and at 10 mg/kg bw/d also a reduction was noted. In males only a slight reduction was observed at 30 mg/kg/bw. This was accompanied by reduced body weight gains in all these groups. - Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- Food intake was lowered in the 30 mg/Kg bw/day females in the last week.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Dose related effects were noted in the hematological parameters.
Haematological observations were reduction in red blood cells counts in both males and females which were statistically significant at 10 and 30 mg/kg bw/d for males and at 30 mg/kg bw/d for females. Furthermore, haematocrit values were slightly reduced in all dose groups in females. Further, the values for mean corpuscular haemoglobin (MCH) and mean corpuscular volume (MCV) were slightly increased in males and females of all dose groups. However, all changes were in the range of the historical controls - Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Dose related effects were noted in the clinical parameters.
Some differences were observed with regard to Na, Ca, K, glucose, cholesterol as well as in the levels of alkaline phosphatase and aspartate aminotransferase. It was argued that all values were well within the range of historical controls. - Urinalysis findings:
- not specified
- Behaviour (functional findings):
- effects observed, treatment-related
- Description (incidence and severity):
- Motility impairment in a few 30 mg/Kg/day rats
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Relative organ weights were statistically significantly increased in xmales and females at 30 m/kg bw/d for liver, kidneys and heart, the latter being additionally elevated (statistically significant) in males at 10 mg/kg bw/d. In addition, at 30 mg/kg bw slight increases were observed in relative testes weights in males and relative brain weights in females (both statistically significant). Despite the results of the statistical analyses of differences to controls, the differences were slight and all mean values remained well within the range of historical control data. The only organ in which a histopathological correlate was observed was the liver (centrilobular hepatocytic hypertrophy in 5 10 mg/Kg bw/day males and in most high-dose males and females. Hepatocytic necrosis in one 30 mg/Kg bw/day male).
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Dark and firm areas in the liver in three 30 mg/Kg bw/day males.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Centrilobular hepatocytic hypertrophy in five 10 mg/Kg bw/day males and in most 30 mg/Kg bw/day males and females. Hepatocytic necrosis in one 30 mg/Kg bw/day male. Nephropathy (tubular basophilia / dilatation and /or chronic inflammation) in five 10 mg/Kg bw/day males and six 30 mg/kg bw/day males.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 3 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- organ weights and organ / body weight ratios
- other: Significant changes were noted at doses above 3 mg/Kg bw/day
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 10 mg/kg bw/day (nominal)
- System:
- other: Hepatic and renal system
- Organ:
- kidney
- liver
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
- Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for the test compound Basic violet 2 is considered to be 3 mg/Kg bw/day.
- Executive summary:
Repeated dose oral toxicity study was performed to determine the oral toxic nature ofBasic Violet 2upon repeated exposure for 13 weeks to rats. The test chemical dissolved in water as vehicle at dose levels of 3, 10 or 30 mg/kg bw/day was administered by the gavage route to 10 male and 10 female Sprague Dawley Hsd: SD strain rats for 13 weeks. The animals were observed for mortality, clinical signs, ophthalmology, neurotoxicity, body weight and organ weight changes, food intake, hematological and clinical chemistry changes. Staining of the faeces in all test groups. Occasional hunched posture and dyspnoea in a few 30 mg/kg bw/day rats was noted. On day 57, 2 females from the 30 mg/Kg bw/day died due to misdosing. Females of the 30 mg/Kg bw/day showed reduced body weight from day 8 of treatment.With regard to body weight a statistically significant reduction was observed in females at 30 mg/kg/bw and at 10 mg/kg bw/d also a reduction was noted. In males only a slight reduction was observed at 30 mg/kg/bw. This was accompanied by reduced body weight gains in all these groups. In females at 30 mg/kg/bw also food consumption was reduced. Food intake was lowered in the 30 mg/Kg bw/day females in the last week. Dose related effects were noted in the hematological parameters.Haematological observations were reduction in red blood cells counts in both males and females which were statistically significant at 10 and 30 mg/kg bw/d for males and at 30 mg/kg bw/d for females. Furthermore, haematocrit values were slightly reduced in all dose groups in females. Further, the values for mean corpuscular haemoglobin (MCH) and mean corpuscular volume (MCV) were slightly increased in males and females of all dose groups. However, all changes were in the range of the historical controls.Dose related effects were noted in the clinical parameters.Some differences were observed with regard to Na, Ca, K, glucose, cholesterol as well as in the levels of alkaline phosphatase and aspartate aminotransferase. It was argued that all values were well within the range of historical controls. Relative organ weights were statistically significantly increased in xmales and females at 30 m/kg bw/d for liver, kidneys and heart, the latter being additionally elevated (statistically significant) in males at 10 mg/kg bw/d. In addition, at 30 mg/kg bw slight increases were observed in relative testes weights in males and relative brain weights in females (both statistically significant). Despite the results of the statistical analyses of differences to controls, the differences were slight and all mean values remained well within the range of historical control data. The only organ in which a histopathological correlate was observed was the liver (centrilobular hepatocytic hypertrophy in five 10 mg/Kg bw/day males and in most high-dose males and females. Hepatocytic necrosis in one 30 mg/Kg bw/day male).Dark and firm areas in the liver in three 30 mg/Kg bw/day males. Centrilobular hepatocytic hypertrophy in five 10 mg/Kg bw/day males and in most 30 mg/Kg bw/day males and females. Hepatocytic necrosis in one 30 mg/Kg bw/day male. Nephropathy (tubular basophilia / dilatation and /or chronic inflammation) in five 10 mg/Kg bw/day males and six 30 mg/kg bw/day males.
At the doses 30 and/or 10 mg/kg bw/day histopathological findings in liver and kidney indicate organ toxicity which is supported by changes in body and organ weights as well as in biochemical parameters (cholesterol, aspartate aminotransferase, alkaline phosphatase). Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for the test compound Basic violet 2 is considered to be 3 mg/Kg bw/day
Reference
Table: Details on hematological and clinical chemistry parameters
Dose (mg/Kg bw/day) |
3 |
10 |
30 |
Dose related |
|||
Male |
Female |
Male |
Female |
Male |
Female |
||
Hematology |
|
|
|
|
|
|
|
Hematocrit |
Dc |
- |
Dc |
- |
Dc |
- |
yes |
RBC count |
D |
D |
Dc |
D |
Dc |
Dc |
Yes |
Hemoglobin |
- |
- |
- |
Dc |
- |
Dc |
Yes |
MCH |
- |
- |
Ic |
- |
Ic |
- |
Yes |
MCV |
- |
- |
- |
- |
Ic |
- |
|
|
|
|
|
|
|
|
|
Clinical chemistry |
|
|
|
|
|
|
|
Na |
I |
Ic |
Ic |
Ic |
Ic |
Ic |
Yes (males) |
Ca |
Ic |
Ic |
Ic |
Ic |
Ic |
Ic |
Yes (males) |
K |
Ic |
- |
Ic |
- |
Ic |
- |
|
Cholesterol |
- |
- |
- |
- |
Ic |
Ic |
|
Glucose |
- |
Ic |
- |
I |
- |
Ic |
|
ASAT activity |
- |
- |
- |
Dc |
Dc |
Dc |
Yes |
ALP activity |
- |
- |
- |
Dc |
- |
Dc |
Yes |
|
|
|
|
|
|
|
|
Organ weight |
|
|
|
|
|
|
|
Relative liver |
- |
- |
- |
- |
Ic |
Ic |
|
Relative kidney |
- |
- |
- |
- |
Ic |
Ic |
|
Relative Heart |
- |
- |
Ic |
- |
Ic |
Ic |
|
Dc/Ic: Statistically significant decreased/increased compared to the controls
D/I: Decreased/increased, but not statistically significantly compared to the controls
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 3 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Data is from peer reviewed publication
- Organ:
- uterus
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose toxicity: Oral
Data available for the target chemical was reviewed to determine the toxic nature of Basic violet 2. The summary is as mentioned below:
Repeated dose oral toxicity study was performed to determine the oral toxic nature of Basic Violet 2 upon repeated exposure for 13 weeks to rats (SCCS, 2011). The test chemical dissolved in water as vehicle at dose levels of 3, 10 or 30 mg/kg bw/day was administered by the gavage route to 10 male and 10 female Sprague Dawley Hsd: SD strain rats for 13 weeks. The animals were observed for mortality, clinical signs, ophthalmology, neurotoxicity, body weight and organ weight changes, food intake, hematological and clinical chemistry changes. Staining of the faeces in all test groups. Occasional hunched posture and dyspnoea in a few 30 mg/kg bw/day rats was noted. On day 57, 2 females from the 30 mg/Kg bw/day died due to misdosing. Females of the 30 mg/Kg bw/day showed reduced body weight from day 8 of treatment.With regard to body weight a statistically significant reduction was observed in females at 30 mg/kg/bw and at 10 mg/kg bw/d also a reduction was noted. In males only a slight reduction was observed at 30 mg/kg/bw. This was accompanied by reduced body weight gains in all these groups. In females at 30 mg/kg/bw also food consumption was reduced. Food intake was lowered in the 30 mg/Kg bw/day females in the last week. Dose related effects were noted in the hematological parameters.Haematological observations were reduction in red blood cells counts in both males and females which were statistically significant at 10 and 30 mg/kg bw/d for males and at 30 mg/kg bw/d for females. Furthermore, haematocrit values were slightly reduced in all dose groups in females. Further, the values for mean corpuscular haemoglobin (MCH) and mean corpuscular volume (MCV) were slightly increased in males and females of all dose groups. However, all changes were in the range of the historical controls.Dose related effects were noted in the clinical parameters.Some differences were observed with regard to Na, Ca, K, glucose, cholesterol as well as in the levels of alkaline phosphatase and aspartate aminotransferase. It was argued that all values were well within the range of historical controls. Relative organ weights were statistically significantly increased in xmales and females at 30 m/kg bw/d for liver, kidneys and heart, the latter being additionally elevated (statistically significant) in males at 10 mg/kg bw/d. In addition, at 30 mg/kg bw slight increases were observed in relative testes weights in males and relative brain weights in females (both statistically significant). Despite the results of the statistical analyses of differences to controls, the differences were slight and all mean values remained well within the range of historical control data. The only organ in which a histopathological correlate was observed was the liver (centrilobular hepatocytic hypertrophy in five 10 mg/Kg bw/day males and in most high-dose males and females. Hepatocytic necrosis in one 30 mg/Kg bw/day male).Dark and firm areas in the liver in three 30 mg/Kg bw/day males. Centrilobular hepatocytic hypertrophy in five 10 mg/Kg bw/day males and in most 30 mg/Kg bw/day males and females. Hepatocytic necrosis in one 30 mg/Kg bw/day male. Nephropathy (tubular basophilia / dilatation and /or chronic inflammation) in five 10 mg/Kg bw/day males and six 30 mg/kg bw/day males. At the doses 30 and/or 10 mg/kg bw/day histopathological findings in liver and kidney indicate organ toxicity which is supported by changes in body and organ weights as well as in biochemical parameters (cholesterol, aspartate aminotransferase, alkaline phosphatase). Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for the test compound Basic violet 2 is considered to be 3 mg/Kg bw/day
Repeated dose oral toxicity study was also performed by Ohta et al (The Journal Of Toxicological Sciences, 2012) to determine the oral toxic nature of New Fuchsin (CAS no 3248 -91 -7) upon repeated exposure for 7 days to mice. 6 week old C57BL/6J ovariectomized mice were checked for vaginal smears 4 days before the start of the test. The animals were acclimatized for a period of 2 weeks. At 8 weeks of age, non-estrus mice were selected and the test material dissolved in distilled water for given by oral gavage route of exposure at 24 hrs interval for 7 consecutive days. 300 mg/Kg/day was selected as the highest dose for the study based on the dose range finding study performed. 17α-ethynyl estradiol was used as the reference control and solvent control was also included in the study. The amount administered was adjusted to body weight on the day of treatment. The dosing volume was 5Ml/Kg for oral gavage route. The animals were observed daily for clinical signs with the body weight recorded.24 hrs after the last treatment, the animals were euthanized by cervical dislocation. The uterus was carefully dissected at the level of the vaginal fornix, trimmed of fascia and fat under a stereomicroscope and weighed including the luminal fluid (wet weight), then pierced, gently blotted on moistened filter [a[er and weighed again for blot weight.Significant change in uterine weight was noted. Based on the observations made, the Low Observed Effect Level (LOEL) for the test compound New Fuchsin is considered to be 300 mg/Kg/day.
Based on the available data for the target chemical, Basic violet 2 is likely to be toxic upon repeated exposure by oral route of administration.
Justification for classification or non-classification
Based on the available data for the target chemical, Basic violet 2 (CAS no 3248 -91 -7) is likely to be toxic upon repeated exposure by oral route of administration.
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.