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Diss Factsheets

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

Constituent 1
Chemical structure
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

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.