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EC number: 219-956-7
CAS number: 2582-30-1
In accordance with point 8.8.1 of column 1 (Standard Information
Required), Annex VIII of REACH (Regulation EC No. 1907/2006), assessment
of the toxicokinetic behaviour of the substance is performed to the
extent that can be derived from the relevant available information. A
toxicokinetic assessment was performed based on the available
physical-chemical data and toxicological information available. Further
testing for the assessment of toxicokinetic behaviour is omitted on this
hydrogen carbonate (CAS 2582 -30 -1) is an organic yellow odourless
experimental studies of the absorption, metabolism, distribution, or
elimination of aminoguanidium hydrogen carbonate (“the substance”) in
mammals are available. Information is utilized from existing toxicology
studies on the substance, or for other very similar materials, and this
data is used to infer, as far as possible, the potential toxicokinetics
of the substance.
availability of the substance depends on its ability to be absorbed
across body surfaces. Factors that affect this process include water
solubility, lipophilicity (measured by the partition coefficient, Kow),
degree of ionization (the dissociation constant, pKa), and molecular
size. Aminoguanidium hydrogen carbonate has a molecular weight of 135
and a water solubility of 5 g/L.
acute oral LD50was greater than 5000 mg/kg bw in an oral
gavage study. All rats dosed with 3100 mg/kg of the test substance
tolerated the treatment without clinical signs or mortality. All rats
dosed with 5000 mg/kg showed sedation and poor general condition within
2 to 6 days after application of the test substance and 4/10 rats died.
OECD 421 reproductive toxicity screening study, treatment with the
substance at dose levels up to 1000 mg/kg was associated with decreased
food consumption, body weights/body weight change and decreased relative
and absolute thymus weights. At
1000 mg/kg bw/day, there was also signs of chronic nephropathy and
hypertrophy of the kidney tubules as well as hepatocellular hypertrophy
in females (NOAEL 300 mg/kg/day in males and 88 mg/kg bw/day in females)
suggesting that some absorption took place.
MW components of the substance are likely more readily absorbed than the
higher MW components.
physical chemical properties do not preclude absorption. In the absence
of quantitative information, 50% bioavailability following oral
administration is assumed for the purposes of human risk assessment.
acute dermal LD50for aminoguanidium hydrogen carbonate was
greater than 50000 mg/kg bw in acute dermal toxicity studies, with no
clinical signs, effects on body weight or gross abnormalities at
necropsy. An in vivo skin irritation study with the substance also
showed no toxicity to the test system; however the substance was a skin
sensitizer in the LLNA. As the substance did not appear to show systemic
effects in the dermal study, it is not likely that dermal absorption was
MW components of the substance are likely be more readily absorbed than
the higher MW components.
the purposes of risk assessment however, estimation of mammalian dermal
absorption is made in accordance with principles adopted by the EFSA
guidance on estimating dermal absorption of pesticide active substances
(EFSA, 2012). On this basis, dermal absorption is estimated at 50% for
undiluted substance, which is considered conservative.
Aminoguanidinium hydrogen carbonate is a solid therefore, absorption
through inhalation is unlikely. However, using the REACH principles,
inhalation absorption was considered 100% for the calculation of DNELs
while oral and dermal absorption were considered 50% each.
Metabolism and Elimination
predictions show that the parent compound is hydrolysed to an
intermediate which is further hydrolized and acetylated to form three
metabolites which are ultimately eliminated by phase two metabolism.
the purposes of human risk assessment oral absorption of the substance
is estimated at 50% and dermal absorption is estimated at 50%.
Inhalation absorption is considered 100%. All DNELs are calculated
using an oral OECD 421 study. Therefore, the DNELs for inhalation and
dermal exposure will be very conservative.
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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