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EC number: 232-227-8
CAS number: 7790-86-5
Acute / short-term exposure (systemic and local effects)
- No acute data were available for the inhalation route of exposure. In
accordance with REACH Annex VIII, this study does not need to be
conducted as exposure via inhalation is a less likely than via the
dermal route due to the fact that the substance forms clumps and is
produced as a solution. In addition, an acute inhalation study does not
need to be conducted as the substance is classified as corrosive to the
skin (according to REACH Annex VIII section 8.5, column 2).
- No acute data were available for the dermal route of exposure. No
further testing is required as the substance is classified as corrosive
to skin (category 1C, H314) and corrosive to eyes (Category 1, H318)
according to CLP criteria. According to ECHA's Guidance on Information
Requirements and Chemical Safety Assessment, Part E, Table E.3-1 the
substance should be considered to cause moderate hazard.
Long-term exposure (systemic effects)
- Dermal: No long-term dermal toxicity studies are available for cerium
trichloride. Furthermore, as the substance is classified as corrosive to
the skin, serious local effects may be expected after repeated dermal
exposure to the diluted test item and, for reasons of animal welfare,
the test should be avoided. An oral combined repeated dose toxicity
study with reproduction/developmental toxicity screening has been
performed with the read-across substance cerium trinitrate (Braun,
2013). The No Observed Adverse Effect Level (NOAEL) for systemic effects
(parental animals) was considered to be 330 mg/kg bw/day. However this
value can not be considered relevant for systemic toxicity after
repeated oral exposure as this value was based on local effects rather
than systemic effects: the morphological changes in the stomachs were
reported to be local effects (irritation after repeated oral gavage)
rather than systemic toxicity and the differences in the food
consumption/body weight were considered secondary to the changes in the
stomach. In addition, it is reported that two animals treated at
1000mg/kg bw/day died as a result of the stomach findings. Thus, no
systemic effects related to the repeated oral exposure to the test item
were really identified.
In the same study some changes in some reproduction/developmental
parameters were also observed at the highest dose of 1000 mg/kg bw/day
and the NOEL for reproduction/developmental toxicity was considered to
be 330 mg/kg bw/day. However, clear conclusion could not be drawn on
this study regarding the possible causes of these changes: a secondary
effect resulting from the chemical stress observed in males and pregnant
females due to high local irritation observed in the stomach after
repeated oral gavage of the compound or a primary effect of the
substance). Therefore, these effects could be considered as local
effects rather than true systemic effects.
Overall, as only local effects were observed, there are no adequate data
for route-to-route extrapolation. Thus, a worker-DNEL long-term for
dermal route-systemic effects can not be derived.
No long-term inhalation toxicity studies are available for cerium
trichloride but an oral combined repeated dose toxicity study with
reproduction/developmental toxicity screening (Braun, 2013) exists. As
described here above for the DNEL long-term for dermal route-systemic
effects, these data are not adequate for route-to-route extrapolation.
Therefore a long-term DNEL for workers for inhalation route-systemic
effects can not be derived based on this information. Furthermore, as
the substance is classified as corrosive to the skin, serious local
effects may be expected after repeated inhalation exposure to the
diluted test item and, for reasons of animal welfare, further testing
should be avoided. In addition, the substance appears as a clump and is
produced as a solution. Therefore formation of respirable suspended
particulate matter is unlikely.
Long-term exposure (local
- No reliable repeated dose
toxicity study was available for this substance via the dermal and
inhalation route of exposure. Therefore, a DNEL long-term exposure,
local effects cannot be derived for the dermal and inhalation route.
Furthermore, and due to the
properties of the substance, cerium trichloride appears as a clump and
it is produced as a solution. Therefore formation of and exposure to
respirable suspended particulate matter is unlikely.
Regarding DNEL long-term local
effect, dermal exposure, although no DNEL can be derived, the substance
is corrosive to the skin. Therefore as no reliable dose descriptor can
be set for the irritation/corrosion endpoint, a qualitative assessment
of the potency of the substance is performed according to ECHA's
Guidance on Information Requirements and Chemical Safety Assessment Part
E (2012). This assessment indicates that cerium trichloride is of
moderate hazard. This hazard band will be used for the development of
exposure scenarios with risk management measures and operational
conditions for controlling exposures and thereby risks.
No consumer use is expected. Therefore, no DNEL is derived.
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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