Registration Dossier

Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study according Guideline; GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD 402
Deviations:
yes
Remarks:
Additional determination of dermal absorption of the test item (DOTL)
Principles of method if other than guideline:
Additional determination of dermal absorption of the test item (DOTL), via Sn in plasma
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid; as such
Radiolabelling:
no

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24h
Doses:
2000 mg/kg bw
No. of animals per group:
5 female, 5 male
Control animals:
no

Results and discussion

Signs and symptoms of toxicity:
no effects
Dermal irritation:
no effects
Percutaneous absorptionopen allclose all
Dose:
2000 mg/kg
Parameter:
percentage
Absorption:
0 %
Remarks on result:
other: 3 hours after dosing
Dose:
2000 mg/kg
Parameter:
percentage
Absorption:
0 %
Remarks on result:
other: 24 hours after dosing
Conversion factor human vs. animal skin:
Not relevant, since no absorption was detected

Applicant's summary and conclusion

Conclusions:
The study proves, that no Dioctyltin dilaurate has been absorbed via the dermal route.