Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According Guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch No GSF 4-20079

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
petrolatum
Concentration / amount:
intradermal concentrations were 10%, 1%, 0.1% and 0.01% in physiological saline
epicutaneous exposure with concentrations of 40%, 10%, 2.5% and 0.5% test substance in white petrolatum.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
intradermal concentrations were 10%, 1%, 0.1% and 0.01% in physiological saline
epicutaneous exposure with concentrations of 40%, 10%, 2.5% and 0.5% test substance in white petrolatum.

Results and discussion

Any other information on results incl. tables

No adverse skin reactions were noted on the control sites treated with the vehicle, neither in the conrtol group nor in the test substance grpup. The test substance treated sites were stained orange-red. This probably obscured the reading of very slight to well defined erythema. Therefore a histopathological examination of theses aereas were perfomed.Results of visual and histopathological examinations were combiened to assess the sensitising potential of the test substance.

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
based on the outcome of this study the test substance "DA 010894" Pyrazole DHE should classified as "May cause sensitisation by skin contact".


Executive summary:

The maximisation test according to the EEC guideline B6 was perfomed to reveal a possible sensitising potential of "DA 10894" Pyrazole DHE. 10 female guinea pigs were used as a test substance grooup and another 5 females were used as a negative contraol group.There were two induction exposes (intradermally and epicutaneously) and one epicoutaneous challange expoure.

Test substance concentrations were

  • 1% in physiological saline for the intradermal induction
  • 40% in white petrolatum for the epicutaneous induction and
  • 40% in white petrolatum for the challenge exposure

results:

All animals survived.

No adverse skin reactions were noted on the control sites treated with the vehicle, neither in the conrtol group nor in the test substance grpup. The test substance treated sites were stained orange-red. This probably obscured the reading of very slight to well defined erythema. Therefore a histopathological examination of theses aereas were perfomed.Results of visual and histopathological examinations were combiened to assess the sensitising potential of the test substance.

In the test substance group, 10/10 animals , i.e. 100% of the animals , were regarded as sensitised. As no animal of the negative control group had a positive skin reaction, this was also in the net rate of the sensitised animals in the test substance group.

Therefore, based on the outcome of this study the test substance "DA 010894" Pyrazole DHE should classified as "May cause sensitisation by skin contact".