Registration Dossier
Registration Dossier
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EC number: 429-300-3 | CAS number: 155601-30-2 PYRAZOL P5; PYRAZOLE DHE
Skin sensitisation
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:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 1-(2-hydroxyethyl)-1H-pyrazol-4,5-diyldiammoniumsulfate
- EC Number:
- 429-300-3
- EC Name:
- 1-(2-hydroxyethyl)-1H-pyrazol-4,5-diyldiammoniumsulfate
- Cas Number:
- 155601-30-2
- Molecular formula:
- C5H12N4O5S
- IUPAC Name:
- 2-(4,5-diamino-1H-pyrazol-1-yl)ethan-1-ol; sulfuric acid
- Details on test material:
- Batch No GSF 4-20079
Constituent 1
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".
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