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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The test substance showed no genotoxicity in two bacterial gene reverse mutations tests with and without metabolic activation.

Additionally, the results of a chromosomal aberration test using cultured Chinese Hamster Lung (CHL/IU) cells were negative for genotoxicity.

Link to relevant study records

Referenceopen allclose all

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Only 4 strains used. Less positive controls.
Principles of method if other than guideline:
Method according to Ames, B.N. et al.: Mutat. Res. 31, 347-364
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay
Specific details on test material used for the study:
common name: Porofor N, Pt. 23091979
Target gene:
his
Species / strain / cell type:
other: Salmonella typhimurium TA98, TA100, TA1535, TA1537
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver microsomes
Test concentrations with justification for top dose:
20; 100; 500; 2,500; 12,500 ug/plate
Vehicle / solvent:
- DMSO for Porofor N, Trypaflavin and 2-aminoanthracene
- deion. water for Endoxan
Untreated negative controls:
other: vehicle control
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: Endoxan (Cyclophosphamid); Trypaflavin; 2-Aminoanthracene.
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity, but tested up to precipitating concentrations
Remarks:
at 12,500 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Since precipitation of the test substance was observed at 12,500 µg/plate, this dose level could not be evaluated.

Conclusions:
Interpretation of results: negative

Based on the results of this study, the test substance Porofor N does not need to be classified according to EC/1272/2008 and 67/548/EEC.
Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1997
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay
Target gene:
his, trp
Species / strain / cell type:
E. coli WP2 uvr A
Species / strain / cell type:
S. typhimurium TA 97
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Rat liver S9, induced with phenobarbital and 5,6-benzoflavone.
Test concentrations with justification for top dose:
0; 313; 625; 1250; 2500 and 5000 µg/plate.
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Species / strain:
S. typhimurium TA 97
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity

Precipitation observed at 1250 µg/plate (with metabolic activation) and 2,500 µg/plate (without metabolic activation).

Conclusions:
Interpretation of results: negative
Endpoint:
in vitro cytogenicity / chromosome aberration study in mammalian cells
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1997
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Qualifier:
according to
Guideline:
OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
GLP compliance:
yes
Type of assay:
in vitro mammalian chromosome aberration test
Species / strain / cell type:
other: Chinese hamster lung (CHL/IU) cells
Metabolic activation:
with and without
Metabolic activation system:
Rat liver, induced with phenobarbital and 5,6-benzoflavone.
Test concentrations with justification for top dose:
+/- S9 mix (short-term/continous treatment): 0; 0.4; 0.8; 1.6 mg/mL
Species / strain:
other: CHL/IU
Metabolic activation:
with and without
Genotoxicity:
negative

No signs of clastogenicity or polyploidy was found in the chinese hamster lung (CHL/IU) cells with or without metabolic activation.

Conclusions:
Interpretation of results: negative
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

The test substance showed no genotoxicity in a micronucleus test in mice.

Link to relevant study records
Reference
Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
Adequacy of study:
other information
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
secondary literature
Principles of method if other than guideline:
Acredine orange staining
GLP compliance:
not specified
Type of assay:
micronucleus assay
Species:
mouse
Strain:
other: ddY
Sex:
male
Route of administration:
oral: unspecified
Duration of treatment / exposure:
double oral administration
Remarks:
no data
Sex:
male
Genotoxicity:
negative

negative

The mice were given a double oral dose of the test substance. At both 24 and 48 h after treatment, bone marrow
smears were prepared. Administration of the test substance did not result in a significant increase in the frequency of micronucleated polychromatic erythrocytes.

Only abstract available; no further data.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Genetic toxicity in vitro

Ames test with and without metabolic activation with S9 mix prepared from liver homogenate of Aroclor 1254 pretreated male Sprague-Dawley rats was conducted. At the highest dose level, precipitation of the test substance was observed. The results were not assignable. Neither cytotoxicity nor mutagenicity was observed at doses up to 2500 µg/plate. Therefore, the test substance was considered to be not mutagenic in the Ames assay. (BASF, 1980)

Genetic toxicity in vivo

The mice were given a double oral dose of the test substance. At both 24 and 48 h after treatment, bone marrow smears were prepared. Administration of the test substance did not result in a significant increase in the frequency of micronucleated polychromatic erythrocytes. (Takenaka, 1993)

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No adverse findings on genotoxicity was observed in in vitro or in vivo studies. As a result the substance is not considered to be classified for mutagenicity under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EC) No. 2017/776.