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reaction mass of: tetrasodium 7-(4-(4-fluoro-6-(4-(2-sulfonatoethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate;tetrasodium 7-(4-(4-hydroxy-6-(4-(2-sulfonatoethylsulfonyl)phenylamino)-1,3,5-triazin-2-ylamino)-2-ureidophenylazo)naphthalene-1,3,6-trisulfonate
EC number: 427-650-1 | 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
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- GLP study conducted in accordance with OECD guideline therefore Klimisch 1 study.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
This study is read across to a structural analogue (SA03), which is considered structurally equivalent to the substance to be registered. Justification is attached below under "attached background material".
In the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in rats (Kubaszky, 2011), the test item administered daily by oral gavage to Wistar rats did not result in test item related mortality or systemic adverse effects.
There were no statistically significant differences between the Control and test item-treated groups with regard to reproductive ability or in the mating or gestation indices, or effects considered adverse or toxicologically significant in correlation with the test item administration. Test item administration was considered to have no impact on the duration of the mating period. Successful coitus (sperm positive vaginal smears and/or vaginal plugs) generally occurred within up to 6 days of pairing (cohabitation). No test item effect on the duration of pregnancy or abnormalities in the gestation outcome ascribed to the treatment were observed. No external abnormalities ascribed to treatment were detected at the clinical or external macroscopic examinations of the pups.
In this study, at the 1000 mg/kg bw/day dose level, the intrauterine mortality, post-natal mortality and subsequently the total mortality were higher than control. However, only the post-natal mortality attained statistical significance. These effects were considered to be possibly related to the test item administration although a role of the individual variability could not be excluded.
At 1000 mg/kg bw/day, the mean number of viable pups was -26.1% lower than control on PND0 and -30.4% lower on PND4, attaining statistical significance when evaluated for the total number of pups. These results correlated with the higher post-natal and total mortality observed in the High dose dams.
There were no effects considered adverse on the offspring weight or weight gain at up to and including 250 mg/kg bw/day. At 1000 mg/kg bw/day, when evaluated per litter basis, there were no statistically significant differences to control, however, the mean litter weights were lower than control on both PND0 and PND4. When evaluated for all pups, the mean body weights were statistically significant, slightly lower up to -7% than control: on PND0, 6.39 g vs. 6.88 g, and on PND4, 10.36 g vs. 11.03 g. As the differences were minor and the dose response was not clear, a test item related adverse effect on the offspring development following administration of 1000 mg/kg bw/day to the parental generation in the conditions of this study could not be ascertained, although it could not be excluded.
Under the conditions of this study, based on histopathological changes in the kidney and stomach, the no observed adverse effect level (NOAEL) for the test item for parental toxicity effects is considered to be 62.5 mg/kg bw/day. For reproductive toxicity, the no observed effect level (NOEL) for parental/adult effects is considered to be 1000 mg/kg bw/day for the males and 250 mg/kg bw/day for the females, due to the higher intrauterine, postnatal and total foetal mortality at 1000 mg/kg bw/day, correlated with a NOEL of 250 mg/kg bw/day for F1 offspring, based on a possible test item-related slight effect on pup-survival and birth weight at 1000 mg/kg bw/day.
Short description of key information:
This study is read across to a structural analogue, which is considered structurally equivalent to the substance to be registered.
Justification for selection of Effect on fertility via oral route:
Only 1 study is available (conducted according to OECD Guideline 422).
Justification for selection of Effect on fertility via inhalation route:
Oral route is considered the most appropriate route of exposure.
Justification for selection of Effect on fertility via dermal route:
Oral route is considered the most appropriate route of exposure.
Justification for classification or non-classification
Additional information
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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