Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vivo
Remarks:
Type of genotoxicity: other: Clastogenicity and aneugenicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 01 March 2011 to 08 March 2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study according to international guideline but not GLP study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: OECD guideline 487 dated 22 July 2010
Qualifier:
according to
Guideline:
other: IWGT recommendations
GLP compliance:
no
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test article identification: CFPPN
Test article batch number: CFPPN 2C4.4
Certificate of analysis: dated 7 October 2010
Conversion factor: No as purity is 95.218% ie, >95%

Administration / exposure

Positive control(s):
Without metabolic activation: Mitomycin C (MITC), 0.01 μg/mL
With metabolic activation: Cyclophosphamide (CP), 1.5 μg/mL

Results and discussion

Test results
Genotoxicity:
negative
Remarks:
No significant increase in the number of micronucleated cells was observed.
Toxicity:
yes
Remarks:
The top concentration retained for scoring 400 μg/mL (49% of cytotoxicity) was considered as corresponding to the required cytotoxicity (50% to 60%) and corresponded to the lowest precipitating concentration in the culture medium.
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion