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EC number: 277-459-0 | CAS number: 73398-89-7
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Remarks:
- Subchronic reproductive study
- 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 from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Subchronic reproductive study of test material was conducted on female rats for 36 days
- Author:
- Maryanti et al
- Year:
- 2 014
- Bibliographic source:
- Cukurova Medical Journal 2014
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Subchronic reproductive study of test material was conducted on female rats for 36 days
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
Test material
- Reference substance name:
- 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride
- EC Number:
- 201-383-9
- EC Name:
- 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride
- Cas Number:
- 81-88-9
- Molecular formula:
- C28H31N2O3.Cl
- IUPAC Name:
- 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthenium chloride
- Details on test material:
- - Name of test material (as cited in study report): Rhodamine B
- Molecular formula : C28H31N2O3Cl
- Molecular weight : 479.017 g/mole
- Substance type: Organic
- Physical state: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- No data available
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Laboratory Pharmacology Brawijaya University.
- Weight at study initiation: (P) -150-200 g
- Diet : ad libitum
- Water: ad libitum
- Temperature (°C):22’C
- Photoperiod (hrs dark / hrs light): 12-h light/dark
Administration / exposure
- Route of administration:
- other: orally using probe.
- Vehicle:
- other: double distilled water
- Details on exposure:
- Test material was dissolved with double distilled water and administered orally using probe.
- Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 36 days
- Frequency of treatment:
- No details
- Details on study schedule:
- No data available
Doses / concentrations
- Remarks:
- 4.5, 9 ,and 18 mg/200gm body weight=22.5,45, 90 mg/kg
- No. of animals per sex per dose:
- 28 rats
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data available
- Positive control:
- No data available
Examinations
- Parental animals: Observations and examinations:
- OTHER: Cycle determination was started at the end of
the treatment. The cycle of each female rat was determined by observation of vaginal smears, which were taken using a plastic tip. - Oestrous cyclicity (parental animals):
- Estrous cyclicity was observed
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- No data available
- Postmortem examinations (offspring):
- No data available
- Statistics:
- Data are presented as mean ± SD and differences between groups were analyzed using 1-way ANOVA with SPSS 19.0 statistical package. Post Hoc test was used if the ANOVA was significant. p < 0.05 was considered statistically significant.
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- The test material reduces thickness of endometrium significantly compared to the control (P < 0.05). The 22.5,45 mg/kg doses did not generate significant difference in the thickness of endometrium (P> 0.05)
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- effects observed, treatment-related
- Description (incidence and severity):
- In the 90mg/kg dose group increase ovarian MDA levels significantly than the control (P < 0.05). There was no significant difference in the
In 22.5 and 45 mg/kg dose group compared to the third dose (P > 0.05).Administration of test material in 45 and 90mg/kg dose group in female rats can reduce thenumber of primary, secondary, and De Graaf follicles significantly compared to the control (P < 0.05). For primary follicles, there were no significant differences among the three doses group(P> 0.05) Administration of test material in 45 and 90mg/kg dose group in female rats can reduce 17β-estradiol level significantly compared to the control (P < 0.05). - Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 22.5 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- histopathology: non-neoplastic
- reproductive function (oestrous cycle)
- Remarks on result:
- other: overall no effects on estrous cycle
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Other effects:
- not examined
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not examined
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not examined
Effect levels (F1)
- Dose descriptor:
- other: not specified
- Generation:
- F1
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- not measured/tested
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Treatment related:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Relation to other toxic effects:
- not specified
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 22.5 mg/kg base on ovarian toxicity through oxidative stress, a decrease in the number of follicles, and decreased level of 17β-estradiol which ultimately lowered the thickness of endometrium, When female rats were treated with test chemical.
- Executive summary:
The subchronic reproductive study conducted on Wister female rats for 36 days. The test material wasdissolved with double distilled water and administeredat concentrations of 22.5 ,45 and 90mg/kg bw orally using probe.28Female rats were randomly divided into the following four groups: the control group and three treatment group Malondialdehyde level in ovary was measured thiobarbituric acid method using TBARS Assay Kit (R&D system, Catalog Series KGE013, USA). The numbers of primary, secondary, tertiary and de Graaf follicles were calculated from the right ovary cut transversely and then preparation was made and stained histologically with HE and the follicles were calculated using Dotslide Olympus Camera XC 10. The entire cross-section was analyzed and further identified with magnification of 100 X. The cycle of each female rat was determined by observation of vaginal smears, which were taken using a plastic tip. Saline was placed on the vaginal opening, aspirated, and then placed on a microscopic slide.After the sample had dried, it was stained with hematoxylin-eosin. When the dye was removed, the slide was washed in de-ionized water and examined under a binocular microscope. Animals in the diestrus phase were used. The remainder of the animals continued to have their estrous cycles checked daily, being sacrificed always when in diestrus.
The test material reduces thickness of endometrium significantly compared to the control (P < 0.05). The22.5,45 mg/kgdoses did not generate significant difference in the thickness of endometrium (P> 0.05).In the 90mg/kg dose group increase ovarian MDA levels significantly than the control (P < 0.05). There was no significant difference in the 22.5 and 45 mg/kg dose group compared to the 90mg/kg dose group(P > 0.05).Administration of test material in 45 and 90mg/kg dose group in female rats can reduce thenumber of primary, secondary, and De Graaf follicles significantly compared to the control (P < 0.05). For primary follicles, there were no significant differences among the three doses group(P> 0.05) Administration of test material in 45 and 90mg/kg dose group in female rats can reduce 17β-estradiol level significantly compared to the control (P < 0.05).Hence NOAEL was considered to be 22.5 mg/kg based onovarian toxicity through oxidative stress, a decrease in the number of follicles, and decreased level of 17β-estradiol which ultimately lowered the thickness of endometrium, When female rats were treated with test material orally.
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