Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 939-867-3 | CAS number: -
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption
- Type of information:
- other: statement
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: An extended assessment of the toxicokinetic behaviour of Mn(2Na)IDHA was performed, taking into account the chemical structure, the available physico-chemical-data and the available toxicity data.
Data source
Reference
- Reference Type:
- other: Statement
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: TGD, Part I, Annex IV, 2003); ECHA guidance R7c., 2008
- Deviations:
- no
- Principles of method if other than guideline:
- An assessment of dermal absorption potential of Mn(2Na)IDHA is based on its physico-chemical properties and on the results of available toxicity data data.
- GLP compliance:
- no
Test material
- Reference substance name:
- Reaction mass of disodium [2,2'-(imino-kappaN)dibutanedioato-kappa2O1,O4(4-)]manganese(2-) and sodium sulphate
- EC Number:
- 939-867-3
- Cas Number:
- 666748-58-9
- Molecular formula:
- MnC8H7NO8Na2
- IUPAC Name:
- Reaction mass of disodium [2,2'-(imino-kappaN)dibutanedioato-kappa2O1,O4(4-)]manganese(2-) and sodium sulphate
- Reference substance name:
- Manganese chelate of sodium salt N-[1,2 dicarboxyethyl] D,L aspartic acid
- IUPAC Name:
- Manganese chelate of sodium salt N-[1,2 dicarboxyethyl] D,L aspartic acid
- Reference substance name:
- Mn(2Na)IDHA
- IUPAC Name:
- Mn(2Na)IDHA
- Test material form:
- other: microgranulated
Constituent 1
Constituent 2
Constituent 3
Results and discussion
Percutaneous absorption
- Parameter:
- percentage
- Absorption:
- ca. 10 %
- Remarks on result:
- other: due to the logPow of -2.69 and high water solubility (491 g/L).
Applicant's summary and conclusion
- Conclusions:
- No significant dermal absorption is expected for the target substance.
- Executive summary:
Based on physico-chemical properties of Mn(2Na)IDHA, the substance is not likely to penetrate skin to a large extent due to negative logPow: -2.69 and a very high water solubility: 491 g/L. Water solubility above 10.000 mg/L combined with a log P value below 0 indicate that the substance may be too hydrophilic to cross the lipid rich environment of the stratum corneum. Dermal uptake for these substances will be low. The molecular weight of 346.08 g/mol indicates theoretically a certain potential to penetrate the skin (< 500) but in case of such a hydrophilic substance it is rather unlikely. This is supported by the findings of acute dermal toxicity studies of the target substance Mn(2Na)IDHA and free IDHA where no systemic toxicity after exposure via the skin was noted (LD50 > 2000 mg/kg bw; Kropidło, 2010, Report No. DER -11/13; Stropp, 1997, Report No. T3061600). Moreover, an acute dermal irritation / corrosion study in the rabbit (according to OECD 404) for Mn(2Na)IDHA did not demonstrate any irritation after 14 days (Sornat, 2013, Report No. DDR 15/13). This information indicates that Mn(2Na)IDHA is unlikely to penetrate the skin. In a human study, EDTA-CaNa2 did not penetrate the skin, only 0.001% was absorbed within 24 hours of administration (RAR, 2004). In case of dissociated complexes, manganese ions uptake across intact skin would be expected to be extremely limited (ATSDR, 2012). Low absorption potential through the skin would also apply to free IDHA chelating agent due to its high hydrophilicity (water solubility 564 g/L; data for Baypure CX 100 (Bayer)).
Based on very low logPow values, high water solubility and absence of toxicity effects in animal studies conducted with different aminopolycarboxylate chelates: free IDHA, Mn(2Na)IDHA, Mn (2Na) EDTA and Ca (2Na) EDTA, a similar behaviour regarding absorption through the skin is expected. Dermal absorption is considered to be negligible and equal to 10 % (worst-case) as established for substances which meet criteria of low dermal absorption potential mentioned in ECHA guidance R7c. (the value used for hazard assessment: DNEL derivation).
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.
