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EC number: 419-210-2 | CAS number: 178452-71-6 OLIVE-GREEN JB 1170
- 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
NOAEL (oral, 28 d) = 200 mg/kg/day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- System:
- urinary
- Organ:
- kidney
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The repeated dose toxicity of the substance was evaluated in a subacute 28-day toxicity study, according to the OECD Guideline 407 (1981) and the method B.7 of the Directive 92/69/EEC. The substance was administered daily by oral gavage to SPF-bred Wistar rats of both sexes at dose levels of 50, 200 and 1000 mg/kg body weight/day for a period of 28 days. A control group was treated similarly with the vehicle only (bidistilled water). Each dose-group comprised 5 animals per sex which were sacrificed after 28 days of treatment. Additional 5 rats per sex and group were used at 0 and 1000 mg/kg. These animals were treated for 28 days and then observed for further 15-day treatment-free period after which they were sacrificed.
Clinical signs, mortality, food consumption, body weights and ophtalmoscopic examinations were recorded during the treatment and recovery periods.
At the end of the dosing and the treatment-free recovery period, blood samples were withdrawn for haematology and biochemistry analyses. Urine samples were collected for urinalyses.
All animals were killed, necropsied and examined post mortem; histological examinations were performed on organs and tissues.
The treatment with the test substance caused some effects in the kidneys at all dose levels which was indicated by higher kidney weights, some changes in urinalytical parameters (occult blood score, urine discoloration, urine volume) and histopathological findings (tubular degeneration associated with exogenous pigment deposition In kidneys). Regarding the histopathological and urinanalytical findings a dose-relationship was evident.
Based on these results the NOAEL of the substance was established as 200 mg/kg body weight for male and female rats.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), classification in Category 1 for repeated dose toxicity applies to substances that have produced significant toxicity in humans or that, on the basisof evidence from studies in experimental animals, can be presumed to have the potential to produce significant toxicity in humans following repeated exposure. Substances are classified in Category 1 for target organ toxicity (repeat exposure) on the basis of:
— reliable and good quality evidence from human cases or epidemiological studies; or
— observations from appropriate studies in experimental animals in which significant and/or severe
toxic effects, of relevance to human health, were produced at generally low exposure concentrations.
Classification in Category 2 applies to substances that, on the basis of evidence from studies in experimental animals, can be presumed to have the potential to be harmful to human health following repeated exposure. Substances are classified in Category 2 for target organ toxicity (repeat exposure) on the basis of observations from appropriate studies in experimental animals in which significant toxic effects, of relevance to human health, were produced at generally moderate exposure concentrations. If classification is based on results obtained from studies conducted in experimental animals, the dose/concentration guidance values that classify refer to effects seen in a standard 90-day toxicity study conducted in rats. These guidance values are presented in the CLP Regulation (EC 1272/2008) in Annex I, Part 3, Table 3.9.2 for classification in Category 1 and in Annex I, Part 3, Table 3.9.3 for classification in Category 2. For a 28-day study the guidance values is increased by a factor of three: classification in category 1 applies when toxicity by oral route is seen at concentrations below 30 mg/kg/d, while category 2 applies for toxicity at doses between 30 and 300 mg/kg/d.
Based on the results of Repeated Dose 28-Day Oral Toxicity Study OECD 407, the lowest dose of the substance inducing significant/severe target organ toxicity can be established to be 1000 mg/kg b.w./day. Thus, no classification for repeated dose toxicity is warranted under 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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