Registration Dossier
Registration Dossier
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EC number: 402-770-7 | CAS number: 92585-24-5 PAMPLEFLEUR
Additional toxicological data
Administrative data
- Endpoint:
- additional toxicological information
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- APRIL 13, 1988
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: this data is from a study which does not give sufficient experimental details and which are only listed in short abstracts
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- no guideline required
- Guideline:
- other: The method of analysis was an Enzyme Linked Immunoassay (ELISA) developed by Dr. Alan Paine of St. Bartholomew's Hospital Medical College.
- Deviations:
- no
- Principles of method if other than guideline:
- The kidney tissues from rats exposed to the subject materials in the 28 day Subacute Toxicity study were analyzed for a-2 µ -Globulin to confirm the species and sex specific toxicological phenomena associated with hyaline droplet nephropathy.
- GLP compliance:
- no
Test material
- Reference substance name:
- PAMPLEFLEUR
- IUPAC Name:
- PAMPLEFLEUR
- Test material form:
- other: clear liquid
Constituent 1
Results and discussion
Any other information on results incl. tables
The quantities of a-2µ-Globulin in the kidney tissues ranged from 45 to 695µg/gm tissue (VIOLIFF low dose animal and PAMPLEFLEUR high dose animal, respectively). These values would fall within the normal range of the protein in kidneys. However, Dr. Paine noted significant differences in the amounts assayed from fresh tissues versus formalin fixed tissues Some indication of a dose-response effect may be observed for the and PAMPLEFLEUR tissues, but are clearly insufficient to be usable.
Applicant's summary and conclusion
- Conclusions:
- The results of the study are insufficient to determine if the subject material caused hyaline droplet nephropathy.
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