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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 229-313-2 | CAS number: 6471-49-4
- 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:
- Toxicology and Carcinogenesis Study
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from NTP
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicology and Carcinogenesis Studies of C.I. Pigment Red 23 (CAS No. 6471-49-4) in F344 Rats and B6C3F1 Mice (Feed Studies)
- Author:
- U.S. DEPARTMENT OFCOMMERCE National Technical Information Service
- Year:
- 1 992
- Bibliographic source:
- NATIONAL TOXICOLOGY PROGRAM. Technical Report Series. No.411, PB93-228435
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Toxicology and Carcinogenesis Study of C.1. Pigment Red 23 (CAS No. 6471-49-4) in F344 Rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
- EC Number:
- 229-313-2
- EC Name:
- 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
- Cas Number:
- 6471-49-4
- Molecular formula:
- C24H17N5O7
- IUPAC Name:
- 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
- Details on test material:
- Name: 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
SMILES:COc1ccc(N(=O)=O)cc1N=Nc1c2ccccc2cc(C(=O)Nc2cccc(N(=O)=O)c2)c1O
InChI:1S/C24H17N5O7/c1-36-21-10-9-17(29(34)35)13-20(21)26-27-22-18-8-3-2-5-14(18)11-19(23(22)30)24(31)25-15-6-4-7-16(12-15)28(32)33/h2-13,30H,1H3,(H,25,31)/b27-26+
Molecular Formula: C24H17N5O7
Molecular Weight: 487.4263 g/mole
Constituent 1
- Specific details on test material used for the study:
- Name: 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide
SMILES:COc1ccc(N(=O)=O)cc1N=Nc1c2ccccc2cc(C(=O)Nc2cccc(N(=O)=O)c2)c1O
InChI:1S/C24H17N5O7/c1-36-21-10-9-17(29(34)35)13-20(21)26-27-22-18-8-3-2-5-14(18)11-19(23(22)30)24(31)25-15-6-4-7-16(12-15)28(32)33/h2-13,30H,1H3,(H,25,31)/b27-26+
Molecular Formula: C24H17N5O7
Molecular Weight: 487.4263 g/mole
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: Frederick Cancer Research Center (Frederick, MD)
- Age at study initiation: 56 days old
- Weight at study initiation: No data available
- Fasting period before study: No data available
- Housing: Rats were housed five per cage. Cages were rotated vertically once every two weeks.
- Diet (e.g. ad libitum):NIH-07 Rat, meal (Zeigler Bros., Inc., Gardners, PA), ad libitum
- Water (e.g. ad libitum):Tap water (Birmingham Water Works) in glass water bottles with stainless steel sippers (Edstrom Automatic Watering Systems, Waterford, WI), ad libitum
- Acclimation period:20 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):17.8° C-25.6° C
- Humidity (%):15%-85%
- Air changes (per hr): minimum 15 changes/hour
- Photoperiod (hrs dark / hrs light):12 hours/day
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: NIH-07 Rat, meal
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: of NIH-07 Rat as meal premix with the appropriate amount of C.I. Pigment Red 23.
DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): NIH-07 Rat as meal, - Storage temperature of food:2 weeks for 45 °C
VEHICLE
- Justification for use and choice of vehicle (if other than water):No data
- Concentration in vehicle: No data
- Amount of vehicle (if gavage): No data
- Lot/batch no. (if required): No data
- Purity: No data - Details on mating procedure:
- Not specified
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not specified
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- Daily
- Details on study schedule:
- Not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Dose / conc.:
- 425 mg/kg bw/day
- Remarks:
- for male
- Dose / conc.:
- 1 100 mg/kg bw/day
- Remarks:
- for male
- Dose / conc.:
- 2 100 mg/kg bw/day
- Remarks:
- for male
- Dose / conc.:
- 500 mg/kg bw/day
- Remarks:
- for female
- Dose / conc.:
- 1 300 mg/kg bw/day
- Remarks:
- for female
- Dose / conc.:
- 2 600 mg/kg bw/day
- Remarks:
- for female
- No. of animals per sex per dose:
- Total: 480
0 mg/kg/day: 60 male
425 mg/kg/day: 60 male
1100 mg/kg/day: 60 male
2100 mg/kg/day: 60 male
500 mg/kg/day: 60 female
1300 mg/kg/day: 60 female
2600 mg/kg/day: 60 female - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:Because levels of C.I. Pigment Red 23 as high as 2500 or 50,000 mg/kg in the feed did not adversely affect survival and mean body weights in the 17-day and 13-week studies, nor cause any chemical-related lesions, doses of 0, 425, 1100 and 2100 mg/kg bw for male and 500, 1300 and 2600 mg/kg/day for female were selected for the 2-year studies.
- Positive control:
- Not specified
Examinations
- Parental animals: Observations and examinations:
- Mortality, clinical sign, body weight and feed Consumption were examined.
- Oestrous cyclicity (parental animals):
- Not specified
- Sperm parameters (parental animals):
- Not specified
- Litter observations:
- Not specified
- Postmortem examinations (offspring):
- Not specified
- Statistics:
- Probability of survival was estimated by the product-limit procedure of Kaplan and Meier; Neoplasm Incidences were analyzed by adjusting for intercurrent mortality is the prevalence Dinse and Lagakos. alternative methods of statistical analysis were used for rapidly lethal neoplasms, and the Fisher exact test and the Cochran-Armitage trend test. Nonneoplastic Lesion Incidences were analyzed by the Fisher exact test was used, a procedure based on the overall proportion of affected animals. Organ and body weight data analyzed using parametric multiple comparison procedures of Dunnett and Williams. Hematology and clinical chemistry data were analyzed using nonparametric multiple comparison methods of Dunn and Shirley. Jonckheere's test was used to assess the significance of dose-response trends and to determine whether a trend-sensitive test (Williams' or Shirley's test) was more appropriate for pairwise comparisons than a test that does not assume a monotonic dose-response trend (Dunnett's or Dunn's test). Average nephropathy severity values were analyzed for significance using the Mann-Whitney U test.
- Reproductive indices:
- Not specified
- Offspring viability indices:
- Not specified
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinical sign were considered to be treatment related.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- When treated with 2100 and 2600 mg/kg bw, Significant increase in survival of treated male and female rats were observed as compared to control.
When treated with 1100 mg/kg bw, Significant increase in survival of treated male rats were observed as compared to control.
The greater survival of the exposed groups was due principally to the chemically related decreased incidence of mononuclear cell leukemia. - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 1300 and 2600 mg/kg bw, Significant decrase in body weights of treated female rats were observed as compared to control.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No effect on food consumption of treated male and female rats was observed as compared to control.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- When treated with 2600 mg/kg bw in female, significant decrase in Hematocrit values, hemoglobin concentration, and erythrocyte counts were observed as compared to control. Which indicat mild anemia.
No effect in mlae rats were observed as compared to control. - Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- When treated with 2600 mg/kg bw in female, Significant increase in Serum total bilirubin were observed as compared to control.
This finding coupled with the mild anemia suggests a mild hemolytic process.
No effect in mlae rats were observed as compared to control. - Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- When treated with 2100 mg/kg bw in male rats, Four renal tubule cell adenomas or carcinomas, renal tubule focal hyperplasia and renal tubule
adenomas were observed.
When treated with 1100 and 2100 mg/kg bw in male rats, Four renal tubule cell adenomas or carcinomas were observed.
When treated with 2500 mg/kg bw in female rats, one renal tubule adenoma was observed.
Although the trend for these renal neoplasms is significant, the incidences are low and do not exceed the historical control range of 0% to 6% in male rats.
When treated with 2100 and 2600 mg/kg bw in male and 1300 and 2600 mg/kg bw in female, significant dose-related decrease in the incidence of mononuclear cell leukemia was observed as compared to control.
No significant histopathological changes were observed in reproductive organ such as testes and mammory gland of treated male and female rats as compared to control. - Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- not specified
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 2 100 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- haematology
- clinical biochemistry
- organ weights and organ / body weight ratios
- histopathology: non-neoplastic
- other: No effect observed
- Remarks on result:
- other: No effect observed
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 specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- other: not specified
- Generation:
- other: not specified
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
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
Any other information on results incl. tables
Summary of the Incidence of Neoplasms in Male Rats in the 2-Year Feed Study of C.I. Pigment Red 23
|
0 ppm |
10000 ppm |
25000 ppm |
50000 ppm |
Genital System |
||||
Epididymis |
(50) |
(2) |
|
(48) |
Fibrous histiocytoma |
1 (2%) |
|
|
|
Preputial gland |
(49) |
(9) |
(8) |
(49) |
Adenoma |
3 (6%) |
5 (56%) |
8 (100%) |
7 (14%) |
Carcinoma |
2 (4%) |
|
|
1 (2%) |
Prostate |
(50) |
(3) |
(2) |
(49) |
Carcinoma, metastatic, stomach |
|
|
|
1 (2%) |
Fibrous histiocytoma |
1 (2%) |
|
|
|
Seminal vesicle |
(50) |
(2) |
|
(49) |
Carcinoma, metastatic, stomach |
|
|
|
1 (2%) |
Fibrous histiocytoma |
1 (2%) |
|
|
|
Testes |
(50) |
(44) |
(44) |
(49) |
Bilateral, interstitial cell, adenoma |
42 (84%) |
43 (98%) |
41 (93%) |
44 (90%) |
Interstitial cell, adenoma |
6 (12%) |
1 (2%) |
3 (7%) |
2 (4%) |
Integumentary System |
||||
Mammary gland |
(49) |
(46) |
(44) |
(43) |
Fibroadenoma |
2 (4%) |
2 (4%) |
2 (5%) |
3 (7%) |
Fibroma |
|
|
|
2 (5%) |
Summary of the Incidence of Nonneoplastic Lesions in Male Rats in the 2·Year Feed Study of C.I. Pigment Red 23
|
0 ppm |
10000 ppm |
25000 ppm |
50000 ppm |
Genital System |
||||
Testes |
(50) |
(44) |
(44) |
(49) |
Atrophy |
1 (2%) |
|
2 (5%) |
|
Hemorrhage |
1 (2%) |
|
|
|
Bilateral, interstitial cell, hyperplasia |
2 (4%) |
|
|
1 (2%) |
Interstitial cell, hyperplasia |
|
1 (2%) |
|
1 (2%) |
Integumentary System |
||||
Mammary gland |
(49) |
(46) |
(44) |
(43) |
Cyst |
|
1 (2%) |
|
|
Galactocele |
1 (2%) |
1 (2%) |
|
|
Hemorrhage |
|
|
1 (2%) |
|
Hyperplasia |
4 (8%) |
7 (15%) |
9 (20%) |
6 (14%) |
Inflammation, chronic |
1 (2%) |
1 (2%) |
|
|
Duct, ectasia |
3 (6%) |
12 (26%) |
7 (16%) |
5 (12%) |
Summary of the Incidence of Neoplasms in Female Rats in the 2-Year Feed Study of C.I. Pigment Red 23
|
0 ppm |
10000 ppm |
25000 ppm |
50000 ppm |
Genital System |
||||
Clitoral gland |
(47) |
(48) |
(47) |
(49) |
Adenoma Carcinoma |
5 (11%) 3 (6%) |
4 (8%)
|
3 (6%) 1 (2%) |
2 (4%)
|
Ovary
|
(50) |
(4) |
(1) |
(50) |
Carcinoma |
|
|
1 (100%) |
|
Granulosa cell tumor NOS |
|
1 (25%) |
|
|
Granulosa cell tumor benign |
|
|
|
1 (2%) |
Thecoma NOS |
|
2 (50%) |
|
|
Uterus |
(50) |
(50) |
(50) |
(50) |
Carcinoma, metastatic, ovary |
|
|
1 (2%) |
|
Fibrosarcoma |
|
|
1 (2%) |
|
Leiomyoma |
|
|
1 (2%) |
|
Cervix, sarcoma stromal |
|
1 (2%) |
|
|
Endometrium, polyp stromal |
7 (14%) |
4 (8%) |
7 (14%) |
13 (26%) |
Endometrium, sarcoma stromal |
1 (2%) |
1 (2%) |
1 (2%) |
|
Vagina |
(8) |
|
(1) |
(4) |
Fibrosarcoma |
1 (13%) |
|
|
|
Leiomyosarcoma |
1 (13%) |
|
|
|
Sarcoma |
|
|
|
1 (100%) |
Schwannoma malignant |
1 (13%) |
|
|
|
Integumentary System |
|
|
|
|
Mammary gland |
(50) |
(38) |
(32) |
(50) |
Adenoma |
|
2 (5%) |
2 (6%) |
1 (2%) |
Carcinoma |
1 (2%) |
2 (5%) |
|
|
Fibroadenoma |
23 (46%) |
24 (63%) |
14 (44%) |
19 (38%) |
Summary of the Incidence of Nonneoplastic Lesions in Female Rats in the 2·Year Feed Study of C.I. Pigment Red 23a
|
0 ppm |
10000 ppm |
25000 ppm |
50000 ppm |
Genital System |
||||
Clitoral gland
|
(47) |
(48) |
(47) |
(49) |
Atrophy |
|
|
1 (2%) |
|
Hyperplasia |
5 (11%) |
3 (6%) |
1 (2%) |
1 (2%) |
Inflammation, acute |
5 (11%) |
1 (2%) |
5 (11%) |
3 (6%) |
Inflammation, chronic |
3 (6%) |
3 (6%) |
2 (4%) |
7 (14%) |
Duct, cyst |
|
|
|
1 (2%) |
Duct, dilatation |
|
1 (2%) |
|
|
Duct, ectasia |
1 (2%) |
|
1 (2%) |
|
Ovary |
(50) |
(4) |
(1) |
(50) |
Follicle, cyst |
2 (4%) |
1 (25%) |
|
|
Uterus
|
(50) |
(50) |
(50) |
(50) |
Cyst |
|
2 (4%) |
1 (2%) |
|
Dilatation |
4 (8%) |
3 (6%) |
2 (4%) |
4 (8%) |
Hemorrhage |
|
1 (2%) |
|
|
Inflammation, acute |
1 (2%) |
|
|
|
Necrosis |
1 (2%) |
|
|
|
Celvix, cyst |
|
2 (4%) |
|
|
Celvix, inflammation, acute |
1 (2%) |
|
|
|
Endometrium, hyperplasia, cystic |
1 (2%) |
|
|
|
Vagina |
(8) |
|
(1) |
(4) |
Inflammation, acute |
1 (13%) |
|
|
|
Inflammation, chronic |
|
|
|
1 (25%) |
Integumentary System Mammary gland
|
(50) |
(38) |
(32) |
(50) |
Galactocele |
1 (2%) |
|
|
|
Hyperplasia |
4 (8%) |
4 (11%) |
5 (16%) |
4 (8%) |
Inflammation, acute |
|
1 (3%) |
|
|
Duct, ectasia |
30 (60%) |
20 (53%) |
22 (69%) |
18 (36%) |
Duct, hyperplasia |
|
1 (3%) |
|
|
Skin |
(50) |
(8) |
(2) |
(49) |
Acanthosis |
|
2 (25%) |
|
|
Hyperkeratosis |
|
2 (25%) |
|
|
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 2100 mg/kg/day for male and 2600 mg/kg bw for female P generation when F344 male and female rats treated with C.1. Pigment Red (3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide) orally in diet for 2 years.
- Executive summary:
In a Toxicology and Carcinogenesis Study, F344 male and female rat were treated with C.1. Pigment Red (3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide) in the concentration of 0,425, 1100 and 2100 mg/kg bw for male and 0, 500, 1300 and 2600 mg/kg/day for female orally in diet for 2 years. The average daily ingestion of C.1. Pigment Red 23 was approximately 425, 1,100, or 2,100 mg/kg body weight per day for male rats and 500, 1,300, or 2,600 mg/kg for females. Significant increase in survival of treated male and female rats were observed at 2100 and 2600 mg/kg bw as compared to control. Significant increase in survival of treated male rats were observed at 1100 mg/kg bw as compared to control. The greater survival of the exposed groups was due principally to the chemically related decreased incidence of mononuclear cell leukemia. No clinical sign were considered to be treatment related. Significant decrease in body weights of female rats were observed at 1300 and 2600 mg/kg bw as compared to control.No effect on food consumption of treated male and female rats was observed as compared to control.In female, significant decrease in Hematocrit values, hemoglobin concentration, and erythrocyte counts at 2600 mg/kg bw as compared to control. Which indicate mild anemia. No effect in male rats was observed as compared to control. Significant increase in Serum total bilirubin were observed in female rats at 2600 mg/kg bw as compared to control. This finding coupled with the mild anemia suggests a mild hemolytic process. No effect in male rats was observed as compared to control. Similarly, at 1300 and 2600 mg/kg bw in female rats, significant increase in relative kidney and brain weight were observed. In addition, at 2100 mg/kg bw in male rats, Four renal tubule cell adenomas or carcinomas, renal tubule focal hyperplasia and renal tubule adenomas were observed. At 1100 and 2100 mg/kg bw in male rats, Four renal tubule cell adenomas or carcinomas were observed. At 2500 mg/kg bw in female rats, one renal tubule adenoma was observed. Although the trend for these renal neoplasms is significant, the incidences are low and do not exceed the historical control range of 0% to 6% in male rats. At 2100 and 2600 mg/kg bw in male and 1300 and 2600 mg/kg bw in female,significant dose-related decrease in the incidence of mononuclear cell leukemia was observed as compared to control.No significant histopathological changes were observed in reproductive organ such as testes and mammary gland of treated male and female rats as compared to control.Therefore, NOAEL was considered to be 500 mg/kg/day for P and F1 generation whenWistarmale and female rats treated withIndigo Carmineorally in dietfor 2 years. Therefore,NOAEL was considered to be 2100 mg/kg/day for male and 2600 mg/kg bw for female P generation whenF344male and female rats treated withC.1. Pigment Red (3-hydroxy-4-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(3-nitrophenyl)naphthalene-2-carboxamide) orally in diet for 2 years.
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.