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EC number: 201-622-7 | CAS number: 85-68-7
- 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
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
A two-generation toxicity test on Pimephales promelas found showed no effects relevant for risk assessment for benzyl butyl phthalate at any of the test concentrations (up to 64.6 — 67.5 µg/L). The NOEC from this study is therefore taken to be 64.6 µg/L.This result is the most sensitive chronic NOEC reported for benzyl butyl phthalate for fish, invertebrates and algae. However, it has not been used for the derivation of the PNEC as the study was designed to investigate endocrine disrupting effects and therefore the exposure concentrations were very low. No effects were observed in the test so the NOEC is unbounded. Instead the NOEC of 75µg/L for Mysidopsis bahia has been used to derive the aquatic PNEC. The PNEC derived is therefore consistent with the PNEC derived in the EU RAR for benzyl butyl phthalate.
Key value for chemical safety assessment
Additional information
Rhodes et al. (1995) performed a chronic toxicity test on the freshwater fish Oncorhynchus mykiss. This was a GLP test and was equivalent/similar to the guidelines EPA 797.1600 (U.S. EPA Toxic Substances Control Act 40 CFR, Part 797.1600 [as modified in Testing Consent Agreement 40 CFR, Part 799], and the ASTM Standard Guide for Conducting Early Life-Stage Toxicity Tests with Fishes). The test showed no effects on hatchability, survival, or growth for benzyl butyl phthalate at any of the test concentrations (up to 0.20 mg/L). This study is used as a key study to fulfil this endpoint.
Hicks (2008) performed a two-generation reproduction and early-life stages test upon the freshwater fish Pimephales promelas in accordance with GLP and based upon multiple guidelines. Endpoints that were examined quantitatively included F0/F1 survival, body length of males and females, body weight of males and females, cumulative F0 fecundity, number of spawns, percent fertility, percent hatchability, and plasma vitellogenin in F1 males and females. No statistically significant effects were observed for any endpoint. In addition, gonadal histopathology was examined qualitatively. The qualitative assessment of gonadal tissues suggested the presence of increases in the incidence and severity of spermatogonia in testes of males in both treatment groups, increased incidence of oocyte atresia in females in both treatment groups, and altered gonadal stage scores in both males and females at the high concentration. These diagnoses were characterized by visual impression of relative changes in the numbers of various cell types. No statistics were carried out to identify if the differences observed were significant or not. They are therefore not relevant for REACH.
Gledhill et al. (1980) performed a 14 day flow-through test with the freshwater fish Pimephales promelas. The 14 -day LC50 was 2.25 mg/L. This study is from a review article and limited information on test methods is available, however it can be used as a supporting study to fulfil this endpoint.
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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