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EC number: 202-163-5
CAS number: 92-52-4
Acute toxicity oral:The reliability of all available studies was not assignable (Klimisch 4). A weight of evidence approach is followed using all these studies. The rat LD50 for biphenyl ranged between 2180 mg/kg bw and 5040 mg/kg bw.Acute toxicity inhalation:The reliability of all available studies was not assignable (Klimisch 4). Acute inhalation studies of Haley et al. (1959), Birch (1976), Younger (1959) and Shewbart (1974) were used in a weight of evidence approach. Only unbounded effect concentrations were available. The highest LC50 value in rats was > 3.47 mg/L (1 hour of exposure).Acute dermal toxicity:Here also, the reliability of all available studies was not assignable (Klimisch 4). The two available studies (Birch, 1976; Rampy et al., 1974) were used in a weight of evidence approach. Only unbounded effect concentrations were available. The highest LD50 value (for New Zealand White rabbit) was > 5010 mg/kg bw.
Acute oral toxicity:
Only Klimisch 4 studies were identified. A weight of evidence approach
is followed using all available studies. The rat LD50 for biphenyl
ranged between 2180 mg/kg bw and 5040 mg/kg bw.
Acute inhalation toxicity:
Biphenyl is a solid, with a melting point of 69 degrees celcius and a
vapour pressure of approximately 1 Pa at 25 degrees celcius. Based on
these properties, and the fact that the particle size is >100
micrometers and therefore the possibility for an acute inhalation
exposure to a vapour or aerosol (liquid or solid) is minimal. As such
data on acute inhalation toxicity are not required according to Annex
VIII, Column 2 of the REACH text.
Irrespective of its physical chemical properties there are inhalation
toxicity studies available for biphenyl. The studies are minimally
reported and involved the exposure of test animals to a vapour created
by heating the test material. As such the reliability of all available
studies was not assignable (Klimisch 4). Acute inhalation studies of
Haley (1959), Birch (1976), Younger (1959) and Shewbart (1974) could be
used to determine unbounded LC50 values and were used in a weight of
evidence approach as only limited information on methods and results
were reported. The highest LC50 value in rats was > 3.47 mg/L (1 hour of
exposure) as reported by Haley (1959). No higher concentrations of
biphenyl were tested. The remaining studies did not specify test
concentrations and are used as supporting evidence.
Based on the available data and the fact that biphenyl is a solid,
additional studies to characterise the acute inhalation toxicity are not
Acute dermal toxicity:
The two Klimisch 4 studies are used in a weight of evidence approach.
Rampy et al (1974) reported a 24 hours LD50 value for biphenyl, tested
on New Zealand White rabbit, which is > 3980 mg/kg bw. The only signs of
toxicity noted were topical effects which included slight to moderate
erythema and slight edema at the site of application. Birch (1976)
reported a 24 hours LD50 value of > 5010 mg/kg bw for the same rabbit
- Based on the available information the LD50 for acute oral toxicity is
higher than 2000 mg/kg bw and consequently no classification for acute
oral toxicity is warranted according to the CLP criteria.
- Based on the physical properties of the substance and the available
inhalation toxicity information (K4 studies) demonstrating a low order
of toxicity at the highest vapour concentrations assessed,
classification for inhalation toxicity is not required
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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