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Diss Factsheets
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EC number: 822-536-1 | CAS number: 2180952-76-3
- 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
Dose range finding study in rats - Oral, gavage
OECD 422 in rats - Oral, gavage
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- good
- System:
- hepatobiliary
- Organ:
- liver
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
The purpose of this study was to evaluate the potential effects of C.I. Solvent Red 175 Solid (solvent stripped) on general toxicity, neurological and reproductive function, and prenatal/early neonatal growth and survival of offspring in rats following repeated gavage administration. Groups of 12 male and 12 female Crl:CD(SD) rats were administered C.I. Solvent Red 175 Solid (solvent stripped) daily by gavage at dose levels of 0 (control), 100, 300, or 1000 mg/kg/day. Males were dosed for at least four weeks prior to breeding and continuing throughout breeding for a minimum of 48 days. The females were dosed for four weeks prior to breeding, continuing through breeding (up to two weeks), gestation (three weeks), and lactation (thirteen days). Effects on general systemic toxicity, neurobehavioral activity, clinical chemistry, hematology, coagulation, thyroid hormone levels, urine parameters, gonadal function, estrous cyclicity, mating behavior, conception, development of the conceptus, parturition and early postnatal growth and survival of pps were evaluated. In addition, a gross necropsy of the adults was conducted with extensive histopathologic examination of tissues. Litter size, pup survival, sex, body weight, anogenital distance, nipple retention, and gross external morphological alterations were assessed.
Treatment-related clinical observations consisted of red feces in all treated animals and red discolored fur in several treated animals which were attributed to the dye nature of the test material and considered a biomarker of exposure.
There were no treatment-related effects on body weight, body weight gain, feed consumption, neurological or reproductive function, or prenatal neonatal survival, growth, or development of the offspring in any treated groups compared to controls.
Males given 1000 mg/kg/day had a treatment-related increase in mean prothrombin time and mean urea nitrogen concentration that were interpreted to be non-adverse.
Males and females given 1000 mg/kg/day had treatment-related higher mean absolute and relative liver weights (11.1% and 11.9% higher for males, respectively, and 10.7% and 7.5% higher for females, respectively). No treatment-related change in liver weight was observed in males or females at 100 or 300 mg/kg/day.
Males given 1000 mg/kg/day had treatment-related slight hypertrophy of periportal hepatocytes and slight necrosis (with or without inflammation) of individual hepatocytes. Females given 1000 mg/kg/day had treatment-related very slight hypertrophy of periportal hepatocytes, very slight vacuolization (consistent with fatty change) of periportal hepatocytes, and very slight necrosis (with or without inflammation) of individual hepatocytes. Males given 300 mg/kg/day had treatment-related very slight hypertrophy of periportal hepatocytes and treatment-related slight necrosis, (with or without inflammation), of individual hepatocytes. No treatment-related liver histopathology was observed at 300 mg/kg/day in females or at 100 mg/kg/day in either sex.
Based on the presence of treatment-related very slight or slight necrosis of individual hepatocytes in males given 300 or 1000 mg/kg/day and in females given 1000 mg/kg/day, the no-observed adverse effect level (NOAEL) for general toxicity was 100 mg/kg/day for males and 300 mg/kg/day for females. The NOEL for neurological and reproductive toxicity or for effects on prenatal/neonatal growth, survival, and development was 1000 mg/kg/day, the highest dose tested.
Justification for classification or non-classification
The toxicological effects (hyertrophy of hepatocytes and necrosis of individual hepatocytes) observed in the liver in male and female rats dosed at 1000 mg/kg and in males dose at 300 mg/kg we rated as slight to very slight. They did not appear to impact the functioning of the organ nor the overal wellbeing of the animals. All effects observed at doses greater than 100 mg/kg bw.
It is therefore concluded that classification for repeated dose toxicity is not required.
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.
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