Registration Dossier
Registration Dossier
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EC number: 208-408-2 | CAS number: 527-09-3
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Remarks:
- Dermal Toxicokinetic
- Type of information:
- (Q)SAR
- Adequacy of study:
- key study
- Study period:
- 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- results derived from a valid (Q)SAR model and falling into its applicability domain, with adequate and reliable documentation / justification
Data source
Materials and methods
- Objective of study:
- absorption
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 428
- GLP compliance:
- no
Test material
- Reference substance name:
- Copper di-D-gluconate
- EC Number:
- 208-408-2
- EC Name:
- Copper di-D-gluconate
- Cas Number:
- 527-09-3
- Molecular formula:
- C12H22CuO14
- IUPAC Name:
- copper(2+) bis(2,3,4,5,6-pentahydroxyhexanoate)
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- other: Human, Human skin and rats, human skin preparations (surgically removed skin from the abdomen), pig, rabbit, rat.
Administration / exposure
- Route of administration:
- dermal
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Taking into account the OECD 417 and the OECD 428, the values obtained with QSAR Toolbox (QT) are reported as % of absorption.
The calculated value reported is 1.42% of absorption; considering the standards, the model is made of skin from which the substance in question is used from 1 to 5 mg / cm2. This means that, if we assume a scenario where a human being of 80 Kg of weight, with an approximate skin extension of 2m2, and an exposure level of 5mg / cm2 (worse of the scenarios paragraph 15 guide 428); the study subject will have an absorption level of 17.75 mg / Kg.
If we compare this value with the lethal dermal dose (2130 mg/Kg), the dose obtained from the absorption in a total exposure in contact with the skin is not representative of a risk.
Applicant's summary and conclusion
- Conclusions:
- The calculated value reported is 1.42% of absorption; considering the standards, the model is made of skin from which the substance in question is used from 1 to 5 mg / cm2. This means that, if we assume a scenario where a human being of 80 Kg of weight, with an approximate skin extension of 2m2, and an exposure level of 5mg / cm2 (worse of the scenarios paragraph 15 guide 428); the study subject will have an absorption level of 17.75 mg / Kg.
If we compare this value with the lethal dermal dose (2130 mg/Kg), the dose obtained from the absorption in a total exposure in contact with the skin is not representative of a risk.
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