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EC number: 284-748-5 | CAS number: 84962-50-5
- 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
Oral LD50 (female) > 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 05 to 24 September, 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The complete study report is not available, thus some details about test conditions are missing.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17 December 2001
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 189 - 255 g
- Fasting period before study: fasted females were used; no details about the fasting period. - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- A group of three fasted females was treated with the test materia; this was followed by a further group of three fasted female animals at the same dose level.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6 females (three animals per step)
- Details on study design:
- Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths or signs of systemic toxicity.
- Gross pathology:
- No abnormalities detected.
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC) No 1272/2008
- Conclusions:
- LD50 (female) > 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 Crl:CD(R) (SD) IGS BR rat. The method followed the OECD Guidelines No. 423.
A group of three fasted females was treated with the test material at a dose level of 2000 m/kg bw. This was followed by a further group of three fasted female animals 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 or signs of systemic toxicity. The acute oral median lethal dose (LD50) of the test material, in the rat, was estimated as being greater than 2000 mg/kg bodyweight.
Conclusion
LD50 (female) > 2000 mg/kg bw
Reference
Individual Bodyweights and Weekly Bodyweight Changes
Dose Level mg/kg | Animal N. and Sex | Bodyweight (g) at Day | Bodyweight Gain (g) During Week | |||
0 | 7 | 14 | 1 | 2 | ||
2000 | 1-0 Female | 220 | 241 | 258 | 21 | 17 |
1-1 Female | 255 | 299 | 314 | 44 | 15 | |
1-2 Female | 192 | 216 | 242 | 24 | 26 | |
2-0 Female | 206 | 230 | 246 | 24 | 16 | |
2-1 Female | 199 | 228 | 236 | 29 | 8 | |
2-2 Female | 189 | 220 | 230 | 31 | 10 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
ACUTE TOXICITY - ORAL ROUTE
The study was performed to assess the acute oral toxicity of the test material following a single oral administration in female rats. The method followed the OECD Guidelines No. 423. No deaths or signs of systemic toxicity were recorded during the exposure and observation periods. The acute oral median lethal dose (LD50) of the test material was estimated as being greater than 2000 mg/kg bodyweight.
ACUTE TOXICITY - INHALATION ROUTE
No acute toxicity studies by inhalation route are available on Acid Yellow 236.
Nevertheless, because of the physical state of the substance inhalation is not an appropriate route of exposure. Particle size distribution showed that the ca 99 % of particles has a diameter greather than 100 µm. Thus, most of the Acid Yellow 236 particles are expected to remain in the upper respiratory tract, which is characterized by efficacious defence mechanisms able to remove them; therefore, respirable particles, able to enter the deepest part of the lung, the non-ciliated alveoli (i.e. D50 of 4 µm), can be considered a minimal portion. This consideration, together with the consideration that the substance is manufactured and handled with suitable risk management measures and with the suitable personal protective equipments, lets to consider the possible absorption of the substance by inhalation route as negligible.
ACUTE TOXICITY - DERMAL ROUTE
According to the Commission Regulation (EU) No 2016/863, amending Annexes VII and VIII to REACH Regulation (EC) No 1907/2006, testing by the dermal route does not need to be conducted if no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation). Recent scientific analysis of available data from in vivo acute toxicity studies have shown that substances that are not toxic via the oral route may be expected with high certainty to be also non-toxic via the dermal route. Therefore, testing those substances via the dermal route does not provide essential information for their safety assessment.
The amendment is the consequence of studies and scientific debates. In particular, the 15th Meeting of Competent Authorities for REACH and CLP (CARACAL, 2014) concluded that an adaptation of point 8.5.3 of Annex VIII to REACH is justified in order to not require information on acute dermal toxicity for substances that have shown no toxicity in acute oral toxicity test up to the limit dose of 2000 mg/kg bw.
In the oral acute toxicity test, no signs of systemic toxicity were recorded.
Justification for classification or non-classification
According to the CLP Regulation (EC) No 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 greater than 2000 mg/kg body weight (based on active ingredient), 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).
Dermal and inhalation route toxicities are not expected; however, no specific acute toxicity investigations are available and none is required.
In conclusion, the test substance is non classified for oral acute toxicity, according to the CLP Regulation (EC) No 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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