Registration Dossier

Administrative data

Endpoint:
dermal absorption in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was well documented and meets generally accepted scientific principles, but was not conducted in compliance with GLP. The study is read across from the ATMP acid.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1983

Materials and methods

Principles of method if other than guideline:
Application of radiolabelled substance and observation of absorption and excretion in urine.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The substance used was a neutralised solution of ATMP.
Radiolabelling:
yes

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Vehicle:
water
Duration of exposure:
24 h
Doses:
200 µl of a 1% aqueous solution was applied to 10 cm² area of shaved skin.
No. of animals per group:
2 male, 2 female

Results and discussion

Any other information on results incl. tables

absorption: 0.603% (male); 0.94% (female)

excretion: the majority of the absorbed radiolabelled ATMP was excreted in the urine within 24 hours of treatment.

Applicant's summary and conclusion

Conclusions:
A neutralised solution of ATMP was tested for dermal absorption. It was concluded that absorption was very low (<1%) and that most of the absorbed substance was excreted in the urine.