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EC number: 232-092-5
CAS number: 7786-17-6
2,2'-methylenebis(6-nonyl-p-cresol) is not classified for skin/eye
irritation or skin sensitisation and is not expected to show any local
effects; DNELs for acute exposure and local effects were therefore not
calculated. The substance does not possess any genotoxic potential.
The most sensitive endpoint was the NOAEL (158 mg/kg bw/day) obtained in
an acceptable 90-day feeding study in rats. The study was performed in
line with good scientific principles and reported to a high standard. In
accordance with Klimisch (1997) the study was assigned a reliability
score of 1. This NOAEL was used as the starting point for the
calculation of systemic DNELs. The reproductive and developmental
toxicity was investigated in a study performed in accordance with
standardised guidelines OECD 421 and EPA OPPTS 870.3550 using an
appropriate test material suitable for read-across to support
2,2'-methylene-bis(6-nonyl-p-cresol); this study showed no effect at the
highest dose tested. Also by read-across, no evidence of carcinogenicity
was seen in acceptable studies; however the highest doses tested for
carcinogenicity by read-across were of the same magnitude as the key
90-day NOAEL of the test material. An additional factor of 2 for
completeness of the database is therefore applied.
For the purposes of human risk assessment there is sufficient
information to consider that 2,2'-methylene-bis(6-nonyl-p-cresol) would
be partially absorbed (50%) by the oral route, and slowly metabolised
and excreted. The consequences of slow metabolism and excretion are
however adequately addressed within the NOAEL of a 90-day study. Human
dermal absorption may be considered to be 10%; inhalation absorption is
assumed to be complete.
The same endpoint used for workers was selected for setting the
long-term DNELs for the general population. The larger assessment factor
for intraspecies sensitivity was considered adequately protective for
the more sensitive population.
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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