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EC number: 279-349-8 | CAS number: 79916-07-7
- 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:
- Organ toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from NTRL
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Initial Submission: Short Term (17-Days) And Sub-Chronic (90-Days) Toxicity Studies with Tinopal CH 3669 in Rats with Cover Letter Dated 100992
- Author:
- Central Inst Nutrit & Food Res
- Year:
- 1 992
- Bibliographic source:
- National Technical Reports Library, OTS0571834,1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Repeated Dose Toxicity Study of Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate (Tinopal CH 3669) in Rats
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate
- Cas Number:
- 41098-56-0
- Molecular formula:
- C40H38N12O18S6.6Na
- IUPAC Name:
- Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate
- Details on test material:
- - Name of test material (as cited in study report): Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate (Tinopal CH 3669)
- Molecular formula (if other than submission substance): C40H38N12O18S6.6Na
- Molecular weight (if other than submission substance): 1305.1422 g/mole
- Substance type: Organic
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate (Tinopal CH 3669)
- Molecular formula (if other than submission substance): C40H38N12O18S6.6Na
- Molecular weight (if other than submission substance): 1305.1422 g/mole
- Substance type: Organic
Test animals
- Species:
- rat
- Strain:
- other: Newly weaned albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Source: CIVO-colony
- Age at study initiation: (P) x wks; (F1) x wks: Newly weaned albino rats
- Weight at study initiation: (P) Males: x-x g; Females: x-x g; (F1) Males: x-x g; Females: x-x g: males (40 – 61 g) and 40 females (37 - 59 g)
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum): The animals were fed on stock diet with Tinopal added at levels of 0, 0.2 and 1.0 %, ad libitum
- Water (e.g. ad libitum): Tap Water, ad libitum
- Acclimation period:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 24°c
Administration / exposure
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- other: stock diet
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The tent compound was thoroughly mixed into stock diet by means of a mechanical blender (type LOdige, Paderborn).
DIET PREPARATION
- Rate of preparation of diet (frequency):once a fortnight
- Mixing appropriate amounts with (Type of food): stock diet
- Storage temperature of food: At room temperature.
VEHICLE
- Justification for use and choice of vehicle (if other than water): stock diet
- Concentration in vehicle: 0, 200, 1000 and 5000 mg/Kg bw
- Amount of vehicle (if gavage):
- Lot/batch no. (if required):
- Purity: - Details on mating procedure:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
- Details on study schedule:
- not specified
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 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)
- Dose / conc.:
- 5 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- Total: 80
0 mg/kg/day: 10 male, 10 female
200 mg/kg/day: 10 male, 10 female
1000 mg/kg/day: 10 male, 10 female
5000 mg/kg/day: 10 male, 10 female - Control animals:
- yes, concurrent vehicle
Examinations
- Parental animals: Observations and examinations:
- Survival, clinical sign, body weight, food consumption and water intake were examined.
- Oestrous cyclicity (parental animals):
- not specified
- Sperm parameters (parental animals):
- not specified
- Litter observations:
- not specified
- Postmortem examinations (parental animals):
- Hematology, clinical chemistry, Organ weight, gross pathology and histopathology were examined.
- Postmortem examinations (offspring):
- not specified
- Statistics:
- not specified
- Reproductive indices:
- not specified
- Offspring viability indices:
- not specified
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 5000 mg/kg bw, all animals looked very sick in the second week of the experiment.
No abnormalities in appearance were observed in 200 and 1000 mg/kg bw treated rats. - Dermal irritation (if dermal study):
- not specified
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- When treated with 5000 mg/kg bw, all animals were died at 5th week of study. Except for one female which succumbed in the 9th week.
No mortality were observed in 200 and 1000 mg/kg bw treated rats. - Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 1000 and 5000 mg/kg bw, Decrease in body weight were observed in treated rats as compared to control.
When treated with 200 mg/kg bw, slight decrease in body weight but not significant as compared to control from week 6 onwards. - Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 5000 mg/kg bw, Decrease in food consumption were observed in treated rats as compared to control.
When treated with 200 and 1000 mg/kg bw, slight decrease in food consumption were observed in treated rats as compared to control. - Food efficiency:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 5000 mg/kg bw, Decrease in food efficiency were observed in treated rats as compared to control.
When treated with 1000 mg/kg bw, slight decrease in food efficiency were observed in treated rats as compared to control.
When treated with 200 mg/kg bw, decrease in food efficiency were observed in treated rats as compared to control. - Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 1000 mg/kg bw, significant increase in percentage of neutrophils and White blood cell counts were observed in treated male and female rats as compared to control.
When treated with 200 mg/kg bw, significant increase in Packed cell volume were observed in male rats but no dose-relationship was observed. - Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- When treated with 1000 mg/kg bw, increase in SGOT activity of females and decreased in SAP activity of males were observed as compared to control.
When treated with 200 mg/kg bw, decreased SGOT activity in males but not observed at 1000 mg/kg bw and is therefore considered incidental.
Slight decrease in G6Pase activity with increasing levels of Tinopal was observed in females only. When the enzyme activity is expressed per unit body weight the figures show a slight tendency to increase with increasing leve1s of Tinopal in males, while in females there are no distinct differences between the groups.
Very slight decrease in G6PD enzyme activity with increasing levels of Tinopal in females. Here, too, this decrease disappeared when the enzyme activity was expressed per unit body weight - 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, treatment-related
- Description (incidence and severity):
- Necrosis, swelling, irregular vacuolization (Sudan III negative) and granular deterioration (eosinophylic, PAS-negative granules) of tubular epithelial cells in the renal cortex of all male and felllll1e rats at 1000 mg/kg bw.
Sloughed necrotic tubular material was often found in tubular lumens. The nuclei of viable tubular cells varied considerably in size and chromatin content. Dilated tubules lined by flattened epithelium and filled with proteinaceous casts were seen in most animals.
Moderate degree of bilateral testicular atrophy were observed in male rats at 1000 mg/kg bw.
A number of seminiferous tubules only contained Sertoli cells and occasional spermatogonia containing an irregularly vacuolated cytoplasm, Partial inhibition of spermatogenosis occurred in other tubules in which many polynucleated giant cells were seen. Varying numbers of seminiferous tubules still showed a normal development of sperm cells.
In the epididymic tubules cellular debris, scattered spermatozoa and a few giant cells were found. - 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:
- 200 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- food efficiency
- haematology
- clinical biochemistry
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- 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
- 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
Applicant's summary and conclusion
- Conclusions:
- NOAEL was considered to be 200 mg/kg/day for P generation when Newly weaned albino male and female rats treated with Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate (Tinopal CH 3669) orally by feed for 90 days.
- Executive summary:
In a Repeated Dose Toxicity Study, Newly weaned albino male and female rats treated with Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate (Tinopal CH 3669) in the concentration of 0, 200, 1000 and 2000 mg/kg/day orally in feed for 90 days. All animals were died at 5th week of study at 5000 mg/kg bw. Except for one female which succumbed in the 9th week. No mortality was observed in 200 and 1000 mg/kg bw treated rats. All animals looked very sick in the second week of the experiment at 5000 mg/kg bw. No abnormalities in appearance were observed in 200 and 1000 mg/kg bw treated rats. Decrease in body weight were observed in treated rats at 1000 and 5000 mg/kg bw as compared to control. Slight decrease in body weight but not significant as compared to control from week 6 onwards at 200 mg/kg bw. Decrease in food consumption were observed in treated rats at 5000 mg/kg bw and slight decrease in food consumption were observed in treated rats at 200 and 1000 mg/kg bw as compared to control. Decrease in food efficiency were observed in treated rats at 5000 mg/kg bw and slight decrease in food efficiency were observed in treated rats at 1000 mg/kg bw as compared to control. Decrease in food efficiency were observed in treated rats at 200 mg/kg bw as compared to control. Similarly, significant increase in percentage of neutrophils and White blood cell counts were observed in treated male and female rats at 1000 mg/kg bw and significant increase in Packed cell volume were observed in male rats at 200 mg/kg bw but no dose-relationship was observed. Increase in SGOT activity of females and decreased in SAP activity of males were observed at 1000 mg/kg bw, decreased SGOT activity in males at 200 mg/kg bw but not observed at 1000 mg/kg bw and is therefore considered incidental. Slight decrease in G6Pase activity with increasing levels of Tinopal was observed in females only. When the enzyme activity is expressed per unit body weight the figures show a slight tendency to increase with increasing levels of Tinopal in males, while in females there are no distinct differences between the groups. Very slight decrease in G6PD enzyme activity with increasing levels of Tinopal in females. Here, too, this decrease disappeared when the enzyme activity was expressed per unit body weight. In addition, increase in relative weights of the kidney, liver and the brain and decrease in testis and ovary weight were observed at 1000 mg/kg bw as compared to control. No effect on reproductive organ weight of 200 mg/kg bw treated male and female rats were observed as compared to control. Large, pale kidneys in all male and female rats at 1000 mg/kg bw. Most of the male rats in this group had strikingly small testicles, other les ions noted at autopsy, such as unilateral hydronephrocis, eurly signs of murine pneuronia, and proteinaceous plugs in urinary bladder, are frequently encountered in the strain of used rats. They may therefore, not be related to the ingestion of the test compound. Necrosis, swelling, irregular vacuolization (Sudan III negative) and granular deterioration (eosinophylic, PAS-negative granules) of tubular epithelial cells in the renal cortex of all male and felllll1e rats at 1000 mg/kg bw. Sloughed necrotic tubular material was often found in tubular lumens. The nuclei of viable tubulur cells varied considerably in size and chromatin content. Dilated tubules lined by flattened epithelium and filled with proteinaceous casts were seen in most animals. Moderate degree of bilateral testicular atrophy were observed in male rats at 1000 mg/kg bw. A number of seminiferous tubules only contained Sertoli cells and occasional spermatogonia containing an irregularly vacuolated cytoplasm, Partial inhibition of spermatogenosis occurred in other tubules in which many polynucleated giant cells were seen. Varying numbers of seminiferous tubules still showed a normal development of sperm cells. In the epididymic tubules cellular debris, scattered spermatozoa and a few giant cells were found. Therefore, NOAEL was considered to be 200 mg/kg/day for P generation when Newly weaned albino male and female rats treated with Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate (Tinopal CH 3669) orally by feed for 90 days.
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