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EC number: 230-303-5 | CAS number: 7023-61-2
- 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
- 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:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Calcium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate
- EC Number:
- 230-303-5
- EC Name:
- Calcium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate
- Cas Number:
- 7023-61-2
- Molecular formula:
- C18H13ClN2O6S.Ca
- IUPAC Name:
- calcium 4-[(5-chloro-4-methyl-2-sulfonatophenyl)diazenyl]-3-hydroxy-2-naphthoate
- Test material form:
- solid: nanoform
- Details on test material:
- - Name of test material (as cited in study report): Pigment Red 48:2
- CAS no. 7023-61-2
- Substance type: pigment
- Physical state: solid
- Analytical purity: 99%
- Impurities: No data
- Lot/batch No.: 061101
- Stability under test conditions: Stable, no change before and after the administration period. (confirmed by IR analysis)
- Storage condition of test material: Stored in a sealed container, at room temperature ( Measured temperature: 16.2-26.4 °C, Acceptance range: 10 -30 oC), in a dark place.
Test materials used in this dossier are all considered to fall under the definition of nano-materials according to the European Commission Recommendation 2011/696/EU as the synthesis and manufacturing of this pigment always yields particulate material with a fine particle size distribution.
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Pigment Red 48:2
- CAS no. 7023-61-2
- Substance type: pigment
- Physical state: solid
- Analytical purity: 99%
- Date received: 2006-11-16
- Lot/batch No.: 061101
- Stability under test conditions: stable
- Storage condition of test material: room temperature
- Other: Identity confirmed by FT-IR
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan (Atsugi Breeding Center)
- Age at study initiation: 8 weeks
- Weight at study initiation: 326 - 376 g and 204 - 236 g
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4 - 23.6°C
- Humidity (%): 49 -65 %
- Air changes (per hr): 6 - 20
- Photoperiod (hrs dark / hrs light): 07:00 - 19:00 light phase
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1% Tween 80 in water
- Details on exposure:
- VEHICLE
- Justification for use and choice of vehicle (if other than water): substance is a poorly soluble pigment
- Amount of vehicle (if gavage): 10 mL/kg - Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- Males : Total of 42 days ( 14 days before mating, 14 days for mating, and 14 days after mating)
Females : Total of 41-50 days (14 days before mating, during mating, pregnancy and up to lactation day 3) - Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 40 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 200 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- - Control: 7 males and 12 females plus each five recovery group animals
- 40 mg/kg bw: 12 males and 12 females
- 200 mg/kg bw: 12 males and 12 females
- 1000 mg/kg bw: 7 males and 12 females plus each 5 recovery group animals - Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Males and Females - on each administration day.
BODY WEIGHT: Yes
- Time schedule for examinations: Males - measured once a week on administration days 0, 7, 14, 21, 28, 35, and 42; Females - measured once a week on administration days 0, 7, 14, and 21, during pregnancy on days 0, 7, 14, and 20, during lactation on day 0 and 4.
FOOD CONSUMPTION AND COMPOUND INTAKE :
- Food consumption for each animal determined: Yes
- Time schedule for examinations : Males - measured once a week on administration days 0, 7, 14, 21, 28, 35, and 42; Females - measured once a week on administration days 0, 7, 14, and 21, during pregnancy on days 0, 7, 14, and 20, during lactation on day 0 and 4.
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Males - day after final administration day
- Anaesthetic used for blood collection: Yes
- Animals fasted: No data
- For parameter see table
- How many animals: five per group
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: day 43 and day 57
- Animals fasted: No data
- How many animals: five per group
- Parameters checked in table
URINALYSIS: Yes
- Time schedule: day 40 and day 54
- How many animals: five males per group
- Parameters: pH, protein, glucose, ketones, bilirubin, occult blood, urobilironen, urine colour
NEUROBEHAVIOURAL EXAMINATION: Function tests and motor activity performed for 5 animals (week 6) - Oestrous cyclicity (parental animals):
- yes
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: not applicable
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
[number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical or behavioural abnormalities, other:]
GROSS EXAMINATION OF DEAD PUPS:
[no / yes, for external and internal abnormalities; possible cause of death was/was not determined for pups born or found dead.] - Postmortem examinations (parental animals):
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
- Organs investigated: heart, Lymph node, mandibular, Lymph node, mesenteric, Thymus, Spleen, Bone marrow, femur, Trachea, lung (and bronchus), Stomach, Small intestine - duodenum, Small intestine - jejunum, Small intestine - ileum, Large intestine - cecum, Large intestine - colon, Large intestine - rectum, Liver, Kidney, Urinary bladder, Testis, Epididymis, Seminal vesicle, Prostate, Coagulating gland, Pituitary, Thyroid, Parathyroid, Adrenal, Brain, Spinal cord, Sciatic nerve, Eyeball, Uterus, Ovary, Vagina
Histopathology evaluation was performed of the control and high dose group for all animals. If findings were observed, then also the slides of the lower dose groups and recovery animals were scored.
ORGAN WEIGHTS
Determination of organ weights (day 43 and day 57) Organ Weights: Thymus, Liver, Kidney, Testicles, Epididymis, Ovaries , Uterus, Brain, Heart - Postmortem examinations (offspring):
- GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations including the cervical, thoracic, and abdominal viscera. - Statistics:
- Multiple comparisons tests were performed with measured values : distribution uniformity was tested by Bartlett’s test , subsequently, one-way variance analysis was performed when the distribution was uniform, and Kruskal-Wallis’s test was performed when the homoscedastic was not recognized. Where significant differences were observed, Duneett’s test or Dunett’s type - multiple comparison tests were conducted.
- Reproductive indices:
- Copulation index, fertility index, implantation index, delivery index, gestation index
- Offspring viability indices:
- Litter size and viability index
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- There were no changes attributed to the test substance
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- There were no changes attributed to the test substance
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- There were no changes attributed to the test substance
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- There were no changes attributed to the test substance
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Urine showed red coloration in some animals of the highest dose group on day 40, but not on day 54
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- There were no changes attributed to the test substance
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- - In the histological examination of animals sacrificed after the dosing period, degeneration/necrosis of the proximal tubular epithelium in the kidney was noted in males of the 1000 mg/kg group and females of the 40 mg/kg group and higher. Moreover, degeneration/necrosis of the papillary ductal epithelium in females of the 1000 mg/kg group and mild basophilic tubule in males of the 1000 mg/kg group and females of the 200 and 1000 mg/kg groups were noted.
- No abnormal changes in the digestive system or other organs/tissues in the histological examination were noted. - Other effects:
- effects observed, treatment-related
- Description (incidence and severity):
- Test substance-colored stool (red) was observed in all animals of the 40 mg/kg group and higher.
Reproductive function / performance (P0)
- Reproductive performance:
- no effects observed
Details on results (P0)
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOEL
- Remarks:
- fertility
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects on fertility observed
- Dose descriptor:
- LOEL
- Remarks:
- systemic toxicity
- Effect level:
- 40 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- histopathology: non-neoplastic
- Dose descriptor:
- NOEL
- Remarks:
- systemic toxicity
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- histopathology: non-neoplastic
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- Lowest effective dose / conc.:
- 40 mg/kg bw/day (actual dose received)
- System:
- urinary
- Organ:
- kidney
Results: F1 generation
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOEL
- Remarks:
- developmental toxicity
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse developmental effects observed
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
Table 1: Histopathology findings in kidney - females (n = 5)
dose (mg/kg bw); R = recovery | 0 | 40 | 200 | 1000 | R0 | R1000 |
Basophilic tubule grade 1 | 1 | 1 | 2 | 0 | 0 | 0 |
Basophilic tubule grade 2 | 0 | 0 | 1 | 1 | 0 | 0 |
Cell infiltration, inflammatory, focal, grade 1 | 1 | 0 | 0 | 0 | 0 | 0 |
Cell infiltration, inflammatory, pelvis, grade 1 | 0 | 0 | 0 | 0 | 1 | 0 |
Cyst | 0 | 1 | 0 | 0 | 0 | 0 |
Degeneration/necrosis, papillary ductal epithelium, grade 1 | 0 | 0 | 0 | 1 | 0 | 0 |
Degeneration/necrosis, tubular epithelium, grade 1 | 0 | 1 | 1 | 0 | 0 | 0 |
Degeneration/necrosis, tubular epithelium, grade 2 | 0 | 0 | 2 | 2 | 0 | 0 |
Mineralization, medulla | 0 | 0 | 0 | 0 | 2 | 1 |
Grade: 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe
Table 2: Histopathology findings in kidney - males (n = 5)
dose (mg/kg bw); R = recovery | 0 | 40 | 200 | 1000 | R0 | R1000 |
Basophilic tubule grade 1 | 1 | 1 | 1 | 0 | 2 | 2 |
Basophilic tubule grade 2 | 0 | 0 | 0 | 4 | 0 | 0 |
Cell infiltration, inflammatory, focal, grade 1 | 0 | 0 | 0 | 1 | 0 | 0 |
Cyst | 0 | 1 | 0 | 0 | 0 | 0 |
Degeneration/necrosis, tubular epithelium, grade 2 | 0 | 0 | 0 | 1 | 0 | 0 |
Dilatation, pelvis | 0 | 1 | 0 | 0 | 0 | 0 |
Mineralization, medulla, grade 1 | 0 | 0 | 0 | 1 | 0 | 0 |
Mineralization, cortex, grade 1 | 0 | 1 | 1 | 1 | 0 | 0 |
Hyaline droplet, tubular epithelium, grade 1 | 0 | 0 | 0 | 0 | 0 | 1 |
Grade: 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe
Applicant's summary and conclusion
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.