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Diss Factsheets
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EC number: 229-388-1 | CAS number: 6505-28-8
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
An oral LD50 of greater than 2000 mg/kg bw was determined and no
mortality was observed in an acute oral toxicity study in rats (GLP,
OECD 423, 2000).
A dermal LD50 of greater than 2000 mg/kg bw was determined and no
mortality was observed in an acute dermal toxicity study with rats (GLP,
OECD 402, 2012).
No mortality was observed after a 4h-exposure (including a 14 -day recovery period) to a dust aerosol (4250 mg/m3) of a related pigment (similar to OECD 403, performed in 1978).
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Well documented study report.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 4 250 mg/m³ air
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
Additional information
Acute oral toxicity
In an acute oral toxicity study according to OECD guideline 401, groups (5/sex) of Sprague Dawley rats (5 weeks old) were given a single oral dose of the test item in corn oil at doses of 0 and 2000 mg/kg bw. Animals were then observed for 14 days.
No mortality was observed. Animals did not exhibit any signs of systemic toxicity and showed expected gains in body weight over the study period. No gross internal lesions were detected during necropsy. Discharge of feces in the same orange color as the test substance was observed approximately 5 hours after administration for 1 male and on day 2 of observation for all males and females. However, no noteworthy changes were found in general condition of the animals.
The acute dermal median lethal dose (LD50) of the test item in the Sprague-Dawley rat was found to be greater than 2000 mg/kg bodyweight.
Acute dermal toxicity
In an acute dermal toxicity study according to OECD guideline 402, a group of ten animals (five males and five females) was given a single, 24 hour, semi-occluded dermal application of the test item to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
No mortality was observed. Animals did not exhibit any signs of systemic toxicity and showed expected gains in body weight over the study period. No gross internal lesions were detected during necropsy.
The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.
Acute inhalation toxicity
Male and female rats were exposed for 4h to a dust aerosol in a nose-only setting to a related pigment (Pigment Yellow 13). After the exposure, rats were observed for 14 days and then subjected to necropsy. The study was performed in 178, but is well reported and the procedure is the one later described in OECD TG 403. In the study report, the particle size was not reported; it is however reported in the follow-up 3 -week-inhalation study. 70 -80% of the particles had a diameter of less than 7 micrometer. No mortality was observed.
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No mortality was observed at the limit dose of 2000 mg/kg bw for both the oral and the dermal route. No mortality was observed for a related substance at the limit dose of 4250 mg/m3. As a result the substance does not need to be classified and labelled for acute toxicity (oral, dermal, inhalation) under Regulation (EC) No 1272/2008, as amended for the seventh time in Regulation (EC) No 1221/2015.
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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