Registration Dossier
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Diss Factsheets
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EC number: 479-410-0 | CAS number: -
- 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
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- Auto flammability
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- 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
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- Nanomaterial aspect ratio / shape
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- Nanomaterial surface chemistry
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- Endpoint summary
- Stability
- Biodegradation
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- 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
Additional information
Absence of adverse effects in male and female reproductive organs after microscopic examination in two 28-day studies via dermal and inhalation exposure are described in the repeated dose toxicity section. In the 28-day inhalation study statistically significant increases in bodyweight-relative testes weights were recorded but microscopic examination found no evident structural change. Ovaries and uteri were examined with no adverse effects recorded. Spermatogenesis was recorded in both high dose and control animals in the 28-day dermal (rabbit) study, suggesting no effects on male fertility; no adverse effects on female reproductive organs were noted in this study. The conduct of a new study of Renewable Diesel reproductive toxicity is not justified since it is expected that test data for a close structural analogue will become available: it is known to this registrant that a testing proposal for a rat 2-generation reproduction study of straight run gas oils has been submitted within the Lead Registrant registration dossier for that substance.
Short description of key information:
Information from repeated dose studies where reproductive organs were microscopically examined and no adverse effects were recorded.
Effects on developmental toxicity
Description of key information
Equivalent EC method study assessing teratogenicity using diesel fuel via inhalation route. Good quality study useful for assessment of this endpoint.
Additional information
In a teratology study conducted with Diesel Fuel, pregnant female rats were exposed the test substance via whole-body inhalation on days 6 to 15 of gestation. Decreased food consumption was seen in the high dose group, however, no treatment-related effects were observed in the test substance groups compared to the controls. There was no evidence of inhibition of foetal growth and development or variation in sex ratio in the group exposured to the test substance. The NOAEC for teratogenicity and maternal toxicity is 401.5 ppm.
Justification for classification or non-classification
Based on available developmental/teratology data on diesel fuel, no classification for effects on development is proposed for Renewable Diesel. No two-generation reproductive toxicity data are available for Renewable Diesel or structural analogues: however such a study has been proposed for the anaalogue straight run gas oils. At present there is insufficient data to assess classification as toxic for reproduction under 67/548/EEC and CLP regulation (1272/2008/EC), with particular reference to effect on fertility. Available analogue test data for developmental toxicity indicate no selective foetotoxicity or teratogenic activity. Renewable Diesel is not classified for reproductive toxicity.
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.
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