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EC number: 232-088-3
CAS number: 7785-84-4
Acute oral toxicity: Three studies are available for the acute oral toxicity endpoint. All studies indicate that trisodium trimetaphosphate has a low potential for systemic toxicity following acute administration via the oral route. The key study (Bradshaw J, 2010) has been conducted to a current guideline (OECD 420) and according to GLP. The acute oral median dose (LD50) of trisodium trimetaphosphate in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP). This conclusion is supported by the additional data provided for this endpoint.Acute inhalation toxicity: One key study exists. The study (Griffiths D, 2012) is conducted under the conditions of GLP and in accordance with an appropriate guideline (OECD 436). This study has been assigned a Klimisch reliability of 1. The LC50 of trisodium trimetaphosphate in male and female Wistar strain rat was found to be > 5.09 mg/L (maximum attainable concentration) and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP).
Clinical Observations and Mortality Data
Dose Level mg/kg
Animal Number and Sex
Effects Noted After Dosing(Hours)
Effects Noted During Period After Dosing(Days)
Bodyweights and Bodyweight Changes
Bodyweight (g) at Day
Bodyweight Gain (g) During Week
Animal Numberand Sex
Time of Death
Killed Day 14
No abnormalities detected
No signs of systemic toxicity
study was performed to assess the acute oral toxicity of the test
material in the Wistar strain rat. The method was designed to meet the
requirements of the following:
Guidelines for Testing of Chemicals No 420 “Acute Oral Toxicity - Fixed
Dose Method” (adopted 17 December 2001)
B1 bis Acute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008
a sighting test at a dose level of 2000 mg/kg, an additional four fasted
female animals were given a single oral dose of test material, as a
suspension in distilled water, at a dose level of 2000 mg/kg
bodyweight. Clinical signs and bodyweight development were monitored
during the study. All animals were subjected to gross necropsy.
were no deaths.
were no signs of systemic toxicity.
animals showed expected gains in bodyweight.
abnormalities were noted at necropsy.
acute oral median lethal dose (LD50) of the test material in
the female Wistar strain rat was estimated to be greater than 2000 mg/kg
bodyweight (Globally Harmonised Classification System-Unclassified).
It is noted that the mean mass median
aerodynamic diameter (MMAD) exceeds the range given in test guidelines
(1-4 μm). This deviation is due to the physical characteristics of the
test item. During the characterisation phase of the study various
techniques were employed in order to try and reduce the achievable MMAD,
these included grinding the test item in a planetary ball mill and
adding particle separation devices into the generation system in order
to try and remove larger particles. During the characterisation phase of
the study the test atmosphere concentration was reduced to 2 mg/L in an
attempt to achieve a particle size as close to 4 μm as possible. This
did reduce the particle size slightly but it wasn’t considered to be
significant. It was, therefore, preferable to expose the animals to a
higher concentration of test item, even though this also increased the
MMAD, as this resulted in the animals being exposed to the highest
possible concentration of particles.
Acute dermal toxicity: adaptation
accordance with Annex VIII, Section 8.5.3, Column 2 of Regulation (EC)
No. 1907/2006 (REACH) testing by the dermal route is appropriate if :
of the substance is unlikely; and
contact in production and/or use is likely; and
physicochemical and toxicological suggest a potential for a significant
rate of absorption through the skin.
skin contact is likely during production and use of trisodium
trimetaphosphate, inhalation of the substance is also likely and as such
an acute inhalation study is available.
according to Annex VIII, Section 8.5.3, Column 2 of REACH, testing by
the dermal route is not appropriate when the physicochemical and
toxicological properties suggest that the rate of absorption through the
skin will not occur at a significant rate.
molecular weight of the substance is >100, this makes dermal absorption
unlikely *. In addition, the very high water solubility of 265 g/l
suggests that the substance is too hydrophilic to cross the lipid rich
environment of the striatum corneum. Taken together these properties
suggest that dermal uptake will be minimal.
the studies conducted to assess the potential for acute oral and
inhalation toxicity concluded that trisodium trimetaphosphate is not
classified in accordance with Regulation (EC) No. 1272/2008 (EU CLP). As
it is considered likely that absorption via the oral or inhalation
routes will be greater than total systemic absorption via the dermal
route, it can be concluded that trisodium trimetaphosphate will not be
classified for acute dermal toxicity. Further in vivo testing is
therefore considered to be scientifically unjustified.
to the ECHA Guidance on Information Requirements and Chemical Safety
Assessment; Chapter R.7c: Endpoint Specific Guidance.
trimetaphosphate is not considered to be classified for acute toxicity
via any route. The data provided for this endpoint are considered to be
conclusive and no further investigation is 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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