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EC number: 202-163-5
CAS number: 92-52-4
This information requirement is waived, on the basis of Column 2 (Annex VII) guidance indicating that testing is not needed where the substance is readily biodegradable and PEC is below the test concentration applied.
Biphenyl was shown to be readily biodegradable, in an OECD 301C study
employing a mixed culture of microorganisms (30 mg/L dry solids) and 100
mg/L biphenyl. As the tested concentration is well above the water
solubility limit (~ 7 mg/L) of the substance, and because the
undissolved test substance occurs as a solid having slightly higher
density than that of water, it can be concluded that the tested
concentration is well above the PEC associated with any wastewater
environment. The PNECstp is derived from the concentration employed in
the OECD 301C test, which according to ECHA Chapter R10 guidance (2008)
is derived from an assessment factor of 10 applied to this tested
concentration. PNECstp is therefore 10 mg/L.
Five studies are provided as weigth-of-evidence to show that NOEC and
effect concentrations are near the solubility limit of the substance.
Since none of these studies has reliability suitable for use in the
chemical safety assessment, none can be used to derive PNECstp.
Rogerson et al. (1983) investigated the survival of the ciliate
Colpidium colpoda after 18 h of exposure in an open test system and of
Tetrahymena elliotti after 24 h of exposure in a closed test system. The
test with C. colpoda was conducted in a covered open test system and
revealed no significant effect at the highest concentration tested,
i.e., 6.3 mg/L. The test with T. elliotti was conducted in a closed test
system without headspace to avoid loss of biphenyl through evaporation
and – similarly – did not reveal significant effects at the highest
concentration tested, i.e., 6.3 mg/L. For Colpidium campylum, a 43-h
LOEC of 5.6 mg/L was determined for biphenyl based on the endpoint
growth (Dive et al., 1980). The test was conducted in an open test
system and some loss of biphenyl may have occurred. Finally, a 40-h
TETRATOX assay with Tetrahymena pyriformis resulted in an EC50 value of
13.7 mg/L (Schultz, 1999). Biphenyl concentrations were not measured but
loss of biphenyl through evaporation may be considered limited because
the test vessels were closed (foam stopcock). The test vessels however
contained a headspace filled with air to which biphenyl may have
evaporated during the test. Schultz (1999) used a carrier solvent and
the EC50 value was above the water solubility of biphenyl. Taking into
consideration all available information, a weight of evidence approach
resulted in a reasonable worst case LOEC of 5.6 mg/L (Dive et al.,
1980). No NOEC was reported by Dive et al. (1980), however, based on the
information in the publication, it can be assumed that the test
concentration series 1.8 – 3.2 – 5.6 – 10.0 mg/L was used and therefore
the NOEC can be assumed to be 3.2 mg/L. Based on the weight of evidence
approach the endpoint requirements can be considered fulfilled in a
reliable way. In case necessary, some further information e.g. from
biodegradability screening tests may be added to the weight of evidence
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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