Registration Dossier

Diss Factsheets

Administrative data

Link to relevant study record(s)

Reference
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
Objective of study:
absorption
Qualifier:
according to guideline
Guideline:
OECD Guideline 417 (Toxicokinetics)
Qualifier:
according to guideline
Guideline:
other: OECD 428
GLP compliance:
no
Species:
other: Human, Human skin and rats, human skin preparations (surgically removed skin from the abdomen), pig, rabbit, rat.
Route of administration:
dermal
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.
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.

Description of key information

Dermal Absorption: 1.42 %

Key value for chemical safety assessment

Absorption rate - dermal (%):
1.42

Additional information

Categories Display