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EC number: 201-622-7
CAS number: 85-68-7
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.
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.
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.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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