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EC number: 241-806-4 | CAS number: 17852-98-1
- 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
Reference
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- combined repeated dose and reproduction / developmental screening
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007 - 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Deviations:
- yes
- Remarks:
- A 14 day recovery element was added.
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
- 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%
- 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. - 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 - Route of administration:
- oral: gavage
- Vehicle:
- other: 1% Tween 80 in water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
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
- Remarks:
- Doses / Concentrations:
0, 40, 200 and 1000 mg/kg bw
Basis:
actual ingested - No. of animals per sex per dose:
- control: seven 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
- Details on study design:
- Standard protocol for OECD 422 testing guideline
- Positive control:
- not applicable
- Observations and examinations performed and frequency:
- 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) - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes (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. - Other examinations:
- determination of organ weights (day 43 and day 57) Organ Weights: Thymus, Liver, Kidney, Testicles, Epididymis, Ovaries , Uterus, Brain, Heart
- 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 Duneett’s type - multiple comparison tests were conducted.
- Details on results:
- 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. Increased kidney weight was noted in males of the 1000 mg/kg group. These changes disappeared after a 2-week recovery period. Test substance-colored stool (red) was observed in all animals of the 40 mg/kg group and higher. Abnormal contents (test substance-colored reddish contents) the digestive organs such as cecum and colon and reddish urine in males were also noted. However, there
were no abnormal changes in the digestive system or other organs/tissues in the histological examination. In other parameters, there were no changes attributed to the test substance on behavior test, body weight, food consumption, hematology, or blood chemistry. Urine showed red coloration in some animals of the highest dose group on day 40, but not on day 54 - Dose descriptor:
- LOEL
- Effect level:
- 40 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Reversible degeneration/necrosis of the proximal tubular epithelium in the kidney.
- Dose descriptor:
- NOEL
- Effect level:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Reversible degeneration/necrosis of the proximal tubular epithelium in the kidney.
- Critical effects observed:
- not specified
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
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
- 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%
- 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
Constituent 1
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:
- see repeated-dose toxicity section
- 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 / concentrations
- Remarks:
- Doses / Concentrations:
0, 40, 200 and 1000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- control: seven 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:
- Seee entry for repeated-dose toxicity
Determination of organ weights (day 43 and day 57) Organ Weights: Thymus, Liver, Kidney, Testicles, Epididymis, Ovaries , Uterus, Brain, Heart - 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 (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. - 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)
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: Kidney: Degeneration/necrosis in proximal tubular epithelium
- Dose descriptor:
- LOEL
- Remarks:
- systemic toxicity
- Effect level:
- ca. 40 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: Kidney: Degeneration/necrosis in proximal tubular epithelium
- Dose descriptor:
- NOEL
- Remarks:
- systemic toxicity
- Effect level:
- ca. 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Kidney: Degeneration/necrosis in proximal tubular epithelium
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: There was no increase in the number of offspring with external anomalies or anury.
Overall reproductive toxicity
- Reproductive effects observed:
- no
Any other information on results incl. tables
The test substance had no effects on the reproductive parameters such as estrous cycle, mating index, fertility index, delivery index, gestation length, number of corpora lutea or implantations, implantation index, gestation index, or parturition or maternal behavior. On the examination of neonates, there were no significant differences in the number of offspring or live offspring, sex ratio, live birth index, or viability index on day 4. No abnormal findings attributed to the test substance were found in external features, clinical signs, body weights, or necropsy of the offspring.
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.
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