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EC number: 263-319-6 | CAS number: 61916-41-4
- 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
Endpoint summary
Administrative data
Description of key information
Oral LD50 rat > 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From December 20th, 2001 to 29th January, 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted according to internationally accepted testing guidelines. Some details about testing procedures and test conditions are missing.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 22 March 1996
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- GLP compliance:
- not specified
- Test type:
- acute toxic class method
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Sprague-Dawley Crl:CD (SD) IGS BR rat (SPL Standard Test Method 512.08).
Fasted before treatment. - Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on oral exposure:
- The test material was administered orally as a suspension in distilled water.
- Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- Three fasted females followed by a group of three fasted males.
- Details on study design:
- Clinical signs and bodyweight development were monitored during the study.
All animals were subjected to gross necropsy. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: Red coloured staining of the faeces and urine was noted in all animals during the day of dosing and one day after dosing. No other signs of systemic toxicity were noted.
- Gross pathology:
- No abnormalities detected.
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- LD50 rat > 2000 mg/kg bw
- Executive summary:
The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley. The method followed the OECD Guidelines for the Testing of Chemicals No. 423 "Acute Oral Toxicity - Acute Toxic Class Method" (adopted 22 March 1996), EU Commission Directive 96/54/EEC Method B1 tris Acute Oral Toxicity (Oral - Acute Toxic Class Method).
A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a group of three fasted animals of the other sex at the same dose level. The test material was administered orally as a suspension in distilled water. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
There were no deaths. Red coloured staining of the faeces and urine was noted in all animals during the day of dosing and one day after dosing. No other signs of systemic toxicity were noted. Necropsy did not reveal any abnormalities.
Conclusion
LD50 rat > 2000 mg/kg bw
Reference
Individual Bodyweights and weekly Bodyweight changes
Animal Number and Sex | Bodyweight (g) at Day | Bodyweight Gain (g) During Week | |||
0 | 7 | 14 | 1 | 2 | |
1-0 Female | 218 | 250 | 265 | 32 | 15 |
1-1 Female | 241 | 275 | 302 | 34 | 27 |
1-2 Female | 212 | 230 | 235 | 18 | 5 |
2-0 Male | 239 | 312 | 363 | 73 | 51 |
2-1 Male | 224 | 301 | 350 | 77 | 49 |
2-2 Male | 221 | 291 | 344 | 70 | 53 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
ORAL ACUTE TOXICITY
The acute oral toxicity of Acid Violet 090 (AV090) potential was investigated in Sprague-Dawley rats. The experiment was conducted according to the OECD guidelines 423 (Acute Toxic Class Method). The animals were treated with a single dose of 2000 mg/kg bw. No deaths were recorded at the end of the study; red coloured staining of the faeces and urine was noted in all animals during the day of dosing and one day after dosing. No other signs of systemic toxicity were noted. Necropsy did not reveal any abnormalities (Clariant SE, 2002).
Furthermore, a summary reporting some toxicological characteristics of AV090 (85 %; remaining composition sodium chloride and sodium sulfate) is available; unfortunately the original study reports are not more available. The available information included in the toxicological characteristics sheet indicate an LD50 p.o. for rats of ca 9000 mg. Dyspnea, apathie, slowed movement sequences, systemic redness, diarrhea, dehydration were reported as clinical observations (BASF SE, 1976).
ACUTE TOXICITY - DERMAL ROUTE
The 15th Meeting of Competent Authorities for REACH and CLP (CARACAL, 2014) concluded acute dermal toxicity is not necessary for substances that have shown no toxicity in acute oral toxicity test up to the limit dose of 2000 mg/kg bw. Furthermore, the Commission services agree that information on acute toxicity via the dermal route should indeed be provided in cases where indications for systemic toxicity in other studies with dermal application (skin irritation or sensitisation studies) has been observed (with the exception of cases where the substance has been shown to be corrosive to skin). The acute oral toxicity test perfomed on DBl221 did not show systemic toxicity (SCAS Europe S.A./N.V., 1997).
Curerntly, only a summary reporting some toxicological characteristics of AV090 (85 %; remaining composition sodium chloride and sodium sulfate) is available, which includes information on acute dermal toxicity. Unfortunately the original study reports are not more available. The information included in the toxicological characteristics sheet indicate an LD50 dermal for rats higher than 2500 mg (BASF, 1976).
REFERENCE
CARACAL, 2014. 15th Meeting of Competent Authorities for REACH and CLP (CARACAL), 8 – 9 July 2014. Charlemagne building, Brussels, Belgium. Brussels, 26 July 2014. Doc. CA/61/2014. Stakeholder proposal to modify REACH standard information
BASF SE. 1976. Ergrbnis der gewerbetoxikologischen vorprüfung. Testing laboratory: BASF AG. Date: 1976-11-26
Justification for classification or non-classification
According to the 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 oral LD50 value was established to be higher than 2000 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).
There are no experimental data for dermal, however, based on the physicochemical properties and based on the acute oral toxicity study outcomes, no adverse effects are expected for this exposure route.
In conclusion, the test substance is non classified for oral acute toxicity, according to the CLP Regulation (EC 1272/2008).
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