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Reaction mass of 4,4'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino[6-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bisarenoate sodium salt and 2-[[4-[bis(2-hydroxyethyl)amino]-6-[[4-[2-[4-[[4-[bis(2-hydroxyethyl)amino]-6-[arenoylamino]-1,3,5-triazin-2-yl]amino]-2-sulfophenyl]ethenyl]-3-sulfophenyl]amino]-1,3,5-triazin-2-yl]amino]arenoate sodium salt and 2,2'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino[6-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bisarenoate sodium salt
EC number: - | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- chronic toxicity: oral
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Deviations:
- yes
- Remarks:
- (limited parameters examined)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Details on test material:
- - Name of test substance (as cited in study report): Blankophor P (acidic sodiumsalt)
- Analytical purity: 81%
- Physical state: solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: 28 - 32 days old
- Weight at study initiation: mean: 48 g
- Housing: single
- Diet: Altromin R-Pulverfutter (Altromin GmbH, Lage/Lippe, Germany), ad libitum
- Water: tap water; ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24 ± 1
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 24 months
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
males: 5.23, 52.29, and 520.78 mg/kg bw/day; females: 7.02, 69.33, and 709.25 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
100, 1000 and 10000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- - test groups: 50
- control group: 100 - Control animals:
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: first 6 months weekly, after that every two weeks
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at 1, 3, 6, 12 and 24 months
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: 10/sex at 24 months otherwise 5/sex
- Parameters checked: haemoglobin, haematocrit, erythrocytes, leucocytes, MCV, MCH, reticulocyte, thromocytes
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at 1, 3, 6, 12 and 24 months
- Animals fasted: No data
- How many animals: 10/sex at 24 months otherwise 5/sex
- Parameters checked: ALP, GOT, GTP, bilirubin, protein, blood glucose, cholesterol
URINALYSIS: Yes
- Time schedule for collection of urine: at 1, 3, 6, 12 and 24 months (urine from 16 o'clock)
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked: glucose, protein, blood, pH, ketone bodies, bile pigments, sediments, urea, creatinine
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes (aorta, eyes, duodenum, jejunum, urinary bladder, heart, testes, pituitary, liver, lung, lymph nodes, stomach, spleen, epididymis, adrenals, kidneys, os femoris, oesophagus, ovaries, pancreas, prostate, seminal vesicle, thymus, skeletal muscle, sternum, trachea, and uterus) - Statistics:
- U-test (Mann); Whitney wilcoxon
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY: No differences compared to negative controls were observed.
- after one year: 2 male and 0 female of 100 animals died in the control group; at 100 ppm 1/50 males and 1/50 females died; at 1000ppm 3/50 males and 0/50 females and at 10000ppm 0/50 males and 0/50 females died
- after two years: in the control group 37/100 males and 25/100 females died; at 100 ppm 23/50 males and 17/50 females died; at 1000ppm 25/50 males and 14/50 females died and at 10000ppm 16/50 males and 17/50 females died
BODY WEIGHT AND WEIGHT GAIN: comparable in all groups
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): normal in all groups
HAEMATOLOGY: No substance-related changes in any parameter were observed.
CLINICAL CHEMISTRY: after 1 month: increase in GOT and GPT at 10000 ppm (males), increase in GPT at 1000 and 10000 ppm (females); no dose-dependent changes in any parameter after 3, 6, 12 and 24 months treatment.
URINALYSIS: normal in all groups
ORGAN WEIGHTS: significant increase of kidey weight in males and females at 10000 ppm, as the difference is < 10%, it is not considered toxicologically relevant; the other changes in organ weight (liver, lung, heart, and testes) were considered not to be treatment-related as no dose-relationship was observed.
GROSS PATHOLOGY: no abnormalities detected
HISTOPATHOLOGY: no abnormalities detected; only findings that are age-related and common for this strain were observed
OTHER: From type, localisation and frequency of observed tumors there is no indication for cancerogenic effect of the test substance
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 10 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: overall effects, highest dose tested
- Dose descriptor:
- NOAEL
- Effect level:
- 709 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: overall effects, highest dose tested
- Dose descriptor:
- NOAEL
- Effect level:
- 521 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: overall effects, highest dose tested
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Food and active ingredient intake:
Dosis [ppm] |
mean food intake |
mean active ingredient intake |
||
|
kg/animal |
g/animal/day |
g/kg bw |
mg/kg bw /day |
|
male |
|||
0 |
16.48 |
22.43 |
- |
- |
100 |
16.49 |
22.44 |
3.84 |
5.23 |
1000 |
16.44 |
22.36 |
38.4 |
52.24 |
10000 |
16.61 |
22.6 |
382.77 |
520.78 |
|
female |
|||
0 |
12.5 |
17.01 |
- |
- |
100 |
12.54 |
17.06 |
5.16 |
7.02 |
1000 |
12.79 |
17.4 |
50.96 |
69.33 |
10000 |
12.86 |
17.52 |
521.3 |
709.25 |
Mean absolute organ weights (mg) |
|||||||||
Dosis (ppm) |
Body weight (g) |
Thymus |
Heart |
Lungs |
Liver |
Spleen |
Kidneys |
Adrenals |
Testes/ ovary |
Males |
|||||||||
0 |
396 |
25 |
1246 |
2036 |
14364 |
742 |
2792 |
54 |
3331 |
100 |
372 |
26 |
1303 |
2716** |
13036 |
665 |
2782 |
57 |
2908* |
1000 |
368* |
23 |
1184 |
2235 |
12755** |
697 |
2740 |
51 |
3171 |
10000 |
390 |
27 |
1353** |
1809 |
15524 |
790 |
3037** |
55 |
3554 |
Females |
|||||||||
0 |
264 |
21 |
959 |
1529 |
9507 |
530 |
1978 |
72 |
114 |
100 |
244* |
19 |
947 |
1508 |
8854 |
551 |
1921 |
71 |
117 |
1000 |
267 |
19 |
971 |
1436 |
9600 |
608 |
2009 |
69 |
106 |
10000 |
265 |
20 |
973 |
1210* |
9938 |
595 |
2108** |
70 |
114 |
* significant different from control; p < 0.05
** significant different from control; p < 0.01
Applicant's summary and conclusion
- Conclusions:
- In this Combined Chronic Toxicity / Carcinogenicity Studies performed to a protocol similar to the OECD Guideline 453 no specific adverse effect was observed by treatment of rats with the test substance 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.
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