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EC number: 482-020-3
CAS number: -
The Starting point for the DNEL derivation (long term systemic,
inhalation) is taken as the NOAEL for systemic effects of 50 mg/kg bw
from the 2 - generation reproductive toxicity study.
The critical effects in this study were increases in Kidney weight in
the top dose (150 mg/kg bw) in the parent and F1 parent generations.
Starting NOAEL = 50 mg/kg bw/day. Converted to Dose descriptor starting
point according to ECHA guidance (practical guide 14). 50/0.38 x 0.67 x
0.5 = 44 mg/m3 ; It is assumed that the oral
absorption rate is 50% of that of the inhalation absorption. This is a
conservative assessment since the available TK data demonstrate >90%
absorption via the oral route.
Due to the potential for inhalation exposure (volatility is low, but
uses involve spraying of the substance as part of a 2 component coating
system), DNELs have been derived for local and systemic effects via
inhalation (long term only).
The toxicity of this substance is limited to local effects only
(Specifically irritation to the skin, eyes, respiratory system, and skin
sensitising potential). In repeated dose toxicity studies there were no
treatment related systemic effects (refer to repeated dose and
reproductive toxicity sections). As such, protecting against local
effects will protect against any systemic toxicity.
The local effects DNEL for inhalation (long term) is derived using the
90 -day inhalation study.
The systemic toxicity DNEL for inhalation (long term) is derived using
the 2 -gen oral toxicity study in rats. The 90 -day inhalation study is
not used as the starting point for the DNEL as the top dose was limited
by local effects, and as such, although it was a NOEL for systemic
toxicity, it is likely the actual NOEL for systemic toxicity is higher.
Therefore the systemic toxicity NOAEL from the 2 -gen study is used with
the appropriate assessment factors to account for dose duration.
DNELS for the dermal route of exposure have not been calculated since
this substance is a skin sensitiser. Protection against sensitising
potential will therefore protect against potential local irritation
effects and systemic toxicity. Please refer to Sections 9 and 10 of the
chemical safety report, and section 11 of the IUCLID for the personal
protective equipment recommendations when handling this substance.
There are no consumer uses for this substance
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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