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Diss Factsheets
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EC number: 269-128-4 | CAS number: 68187-84-8
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Two reliable reproscreening studies with rats according to OECD 422 and under GLP conditions are available, resulting in sufficient quality to assess this endpoint.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Two key studies with regard to repeated dose toxicity are available, based on read across to Blown linseed oil and Blown rapeseed oil. Both studies were performed according to the OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), and validated with reliability 1. In both studies rats were exposed to 0, 150, 450 and 1000 mg/kg bw/day of the test substance, which had a viscosity of 1 (Blown linseed oil) and 18 Poise (Blown rapeseed oil). The tests revealed no parental toxicity up to 1000 mg/kg bw/day for both substances. Furthermore, no reproduction and developmental toxicity was observed for treatment up to 1000 mg/kg bw/day. The parental NOAEL is > 1000 mg/kg bw and the NOAEL (reproduction) and NOAEL (developmental) is >1000 mg/kg/day.
The results of Blown linseed oil and Blown rapeseed oil are read across to Blown castor oil. This is considered justified because 1) they share a similar composition of saturated (0 double bond) fatty acids chains, mono-unsaturated (1 double bond) and poly-unsaturated (>1 double bond) fatty acids chains. 2) The variation in chain length is not believed to affect in any way the reactivity of the raw material oil or of the finished product and by extension the toxicological behaviour of the blown oils, 3) Due to higher level of polyunsaturated fatty acid chains, Blown linseed oil presents the worst case scenario in terms of toxicology (See Category justification in Read Across document for extended explanation), 4) similar oral, dermal and inhalation absorption rates were estimated for these substances and 5) the similar physico-chemical properties. Furthermore, similar toxicity of the oils in this category was observed in the acute oral toxicity test (both LD50 > 2 mg/kg). Thus, for Blown castor oil a NOAEL of > 1000 mg/kg bw is expected for toxicity to reproduction and developmental toxicity.
Short description of key information:
Two studies with read across substances Blown linseed oil and Blown rapeseed oil, in accordance with OECD 422, showing no evidence of toxicity (NOAELparental, NOAELreproduction and NOAELdevelopmental: >1000 mg/kg bw/day).
Justification for selection of Effect on fertility via oral route:
No specific study is selected as two key studies are available from read across substance Blown linseed oil and Blown rapeseed oil.
Effects on developmental toxicity
Description of key information
Two studies with read across substances Blown linseed oil and Blown rapeseed oil, in accordance with OECD 422, showing no evidence of toxicity (NOAELparental, NOAELreproduction and NOAELdevelopmental: >1000 mg/kg bw/day).
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- Two reliable reproscreening studies with rats according to OECD 422 and under GLP conditions are available, resulting in sufficient quality to assess this endpoint.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
A summary of the OECD 422 studies with Blown linseed oil and Blown rapeseed oil, which is applicable to both toxicity to reproduction and developmental toxicity, is presented above (effects on fertility).
Justification for selection of Effect on developmental toxicity: via oral route:
No specific study is selected as two key studies are available from read across substance Blown linseed oil and Blown rapeseed oil, both summarized under toxicity to reproduction.
Justification for classification or non-classification
Based on the available information, Blown castor oil does not have to be classified for toxicity to reproduction or developemtal toxicity in accordance with the criteria outlined in Annex VI of 67/548/EEC and Annex I of 1272/2008/EC.
Additional information
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.