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EC number: 241-883-4 | CAS number: 17958-73-5
- 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
Endpoint summary
Administrative data
Description of key information
Rat oral LD50 > 5000 mg/kg bw
Rat inhalation LC50 > 1895 mg/m3
Rat dermal LD50 > 2000 mg/kg bw
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted testing guidelines. Justification for Read Across is detailed in the endpoint summary and in the Category Justification Report attached to the section 13.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- limited data
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Stain: Albino rat, strain not specified.
- Age at study initiation: young - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 3 x sex x dose
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed
- Clinical signs:
- other: Dyspnoea, exophthalmoses, ruffled fur, and curved body position were seen, being common symptoms in acute toxicity testing. The animals recovered within 11 days.
- Gross pathology:
- At autopsy, no deviations from normal morphology were found.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information According to the CLP regulation. Criteria used for interpretation of results: EU
- Conclusions:
- LD50 > 5000 mg/kg bw.
- Executive summary:
Method
The exploratory (approximate) acute oral LD50 for test substance was investigated by administering a single dose of 5000 mg/kg bw by gavage to the young adult albino rats.
Results
LD50 > 5000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Particle size not specified. Justification for Read Across is detailed in the endpoint summary and in the Category Justification Report attached to the section 13.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany.
- Weight at study initiation: 180 - 200 g. - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric with membrane filter.
- Duration of exposure:
- 1 - 4 h
- Concentrations:
- 163.3, 375, 1225 and 1895 mg/m³ air at 4 hour exposure.
1820 mg/m³ air at 1 hour exposure. - No. of animals per sex per dose:
- 10
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days .
- Necropsy of survivors performed: yes.
- Other examinations performed: clinical signs. - Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1 895 mg/m³ air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 1 820 mg/m³ air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Mortality:
- No mortality occuerred.
- Clinical signs:
- other: At concentrations of 1225 and 1895 mg/m³ air at the 4 hour exposure the animals showed a decreased general condition for about 4 - 6 hours.
- Gross pathology:
- No abnormalities detected.
- Interpretation of results:
- other: not applicable.
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- LC50 (4 h): > 1.895 mg/l air
- Executive summary:
Method
Acute inhalation toxicity was assessed following the method described into the OECD guideline 403.
Results
LC50 (4 h): > 1.895 mg/l air
LC50 (1 h): 1.820 mg/l air
Conclusion
According to CLP Regulation (EC 1272/2008), 3.1 Acute toxicity section, substances can be allocated to one of four toxicity categories based on acute toxicity by the oral, dermal or inhalation route according to the numeric criteria. Acute toxicity values are expressed as (approximate) LD50 (oral, dermal) or LC50 (inhalation) values or as acute toxicity estimates (ATE).
The inhalation LD50 value classification limit for dust is 5.0 mg/l (category 4: 1.0 < ATE ≤ 5.0 mg/l). In the current test an LD50 was non identified; considering the fact that no mortality occurred, a classification category can not be assigned. Thus, a classification according to the CLP Regulation (EC 1272/2008) is not applicable.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 1 895 mg/m³ air
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only a summary is available;. Justification for Read Across is detailed in the endpoint summary and in the Category Justification Report attached to the section 13.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- no
- Remarks:
- Pre GLP.
- Test type:
- standard acute method
- Species:
- rabbit
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean 2205 g.
- Housing: one animal per cage.
- Food: Nafag Würfel Nr. 84.
ENVIRONMENTAL CONDITIONS
- Temperature: 23°C ± 2°C
- Humidity: 55 ± 5%
- Photoperiod: 14 hrs light/day. - Type of coverage:
- occlusive
- Vehicle:
- other: fresh suspension with gum arabic 1% / tap water
- Details on dermal exposure:
- APPLICATION
One application to intact skin. Occlusive dressing (Draize method) for 24 hours.
TEST SITE
- Area of exposure: dehairing of the dorsal skin by shearing.
- % coverage: SURFACE OF 200-300 cm2
REMOVAL OF TEST SUBSTANCE
- Washing: washing the application area with lukewarm water and a sponge.
TEST MATERIAL
- Concentration: 80% - Duration of exposure:
- 24 hours
- No. of animals per sex per dose:
- 3 males and 3 females
- Details on study design:
- - Duration of observation period following administration: 8 days.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: No systemic symptoms were recorded.
- Interpretation of results:
- not classified
- Remarks:
- Migrated information According to the CLP regulation. Criteria used for interpretation of results: EU
- Conclusions:
- LD50 > 2000 mg/kg bw
- Executive summary:
Method
The acute dermal LD50 of the test item was tested in rabbits administed by dermal occlusive dressing (Draize method) at a single concentration of 2000 mg/kg bw.
Results
No deaths occurred.
LD50 > 2000 mg/kg bw
Reference
Skin reactions recorded
Dose mg/kg | Time point | N. of animals with reactions | Reaction |
2000 | 24 hrs | 6/6 | Erythema |
2 days | 1/6 | Erythema, oedema | |
3 days | 1/6 1/6 |
Erythema Oedema |
|
4 days | 1/6 1/6 |
Erythema Scaling, oedema |
|
5 + 6 days | 1/6 | Scaling, oedema | |
7 + 8 days | 2/6 1/6 |
Scaling Scaling, oedema |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Many summaries of tests performed according to official guidelines are available on the analogous substance CAS 16324-27-9 of the Stilbene Fluorescent Whitening Agents category, assessing a LD50 > 10000 mg/Kg bw. The two substances share the same organic functional group and substitution on the triazino moyety with monohydroxyethylamino. They are therefore very similar both according to the chemical structure (Tanimoto similarities > 90 %) than according to metabolic pathway (OECD Toolbox profiling). The two substances differ in the sulphonation degree: the substance under registration (CAS 17958-73-5) is the disulphonate derivative, while CAS 16324-27-9 is tetrasulphonated. The difference in solubility is of almost one order of magnitude (30.2 g/l vs 140 g/l), but this difference has no impact from a toxicological point of view, because both substances are in any case highly soluble, stable and completely dissociated in water.
Further studies are reported the results for the analogous substance CAS 4193-55-9, which has a LD50 > 5000 mg/Kg bw.
This substance is the analogous disulphonated, dihydroxyethylamino substituted. In this case the suphonation degree is the same as that of CAS 17958-73-5, while the substitution on the triazino ring is different (dihydroxyethyl for CAS 4193-55-9, instead monohydroxyethyl for CAS 17958-73-5). From a metabolic point of view, the two substances can be considered very similar because the monohydroxyl derivative is a metabolite of the dihydroxy derivative. In this respect the water solubilities of CAS 17958-73-5 and CAS 4193-55-9 are more similar (30.2 vs 48.2 g/l, respectively) and the LD value of 5000 g/l assessed for CAS 4193-55-9 can be considered as conservative representative for the substance under registration.
A Klimish 2 study for acute dermal toxicity was performed at 2000 mg/Kg bw with no effect on CAS 16324 -27 -9, for which the same argumentation described for acute oral toxicity are applicable.
Because of the physical state and the trade forms, inhalation is not an appropriate route of exposure. Acute toxicity results for the other two exposure routes indicate no concern therefore no testing was performed.One test is available on an analogous substance, performed at the maximum allowed concentration of 1890 mg/m3: no effects were observed.
Within the whole category eleven over fourteen registered substances were tested for acute oral toxicity and seven for dermal: none of the existing tests arisen any concern at the highest tested doses.
Justification for selection of acute toxicity – oral endpoint
Study conducted according to internationally accepted testing guidelines.
Justification for selection of acute toxicity – dermal endpoint
Study conducted according to internationally accepted testing guidelines, in GLP.
Justification for classification or non-classification
The oral LD50 value was established to be greater than 5000 mg/kg body weight, therefore the test substance is out of any classification limit for acute oral toxicity (oral acute toxicity category 4: 300 < ATE ≤ 2000 mg/kg bw).
The dermal LD50 value was established to exceed 2000 mg/kg body weight, which exceeded the highest CLP classification limit (dermal acute toxicity category 4: 1000 < ATE ≤ 2000 mg/kg bw).
The inhalation LC50 value was established to be greater than 1895 mg/m3. For powder the limit for classification is ATE > 5 mg/l i. e. 5000 mg/m3.
Since no effect was observed at the tested concentration and this was the maximum reachable concentration in the test condition, it is assumed that the substance is not classified for inhalation acute toxicity.
In conclusion, the available experimental data are adequate for classification and labelling and the test substance is non classified for oral and dermal acute toxicity, according to the CLP Regulation (EC 1272/2008).
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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