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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No OECD guideline or GLP defined

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
The Ames Salmonella mutation test was used according to the plate incorporation procedure described by Maron and Ames (1983). Five Salmonella typhimurium strains were used: TA98, TA100, TA102; TA1535, and TA1537. This assay was performed with/without metabolic activation as an S9 mixture (Aroclor-1254 -induced rat liver homogenate). Negative and positive controls were used for each strain.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Phthalic acid
EC Number:
201-873-2
EC Name:
Phthalic acid
Cas Number:
88-99-3
Molecular formula:
C8H6O4
IUPAC Name:
benzene-1,2-dicarboxylic acid
Details on test material:
Phthalic acid [C6H4-1,2-(COOH)2; Cas number 88-99-3]; no details about purity given.
Specific details on test material used for the study:
Supplier: Sigma, thus, commercial grade is suggested

Method

Target gene:
Ames Assay
Species / strain
Species / strain / cell type:
other: TA98, TA100, TA102, TA1535, TA 1537
Metabolic activation:
with and without
Metabolic activation system:
S9 (Aroclor-1254 induced rat liver homogenate)
Test concentrations with justification for top dose:
0; 20; 100; 500; 2500; 12500 µM
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
not specified
True negative controls:
yes
Positive controls:
yes
Positive control substance:
other: Without metabolical activation: 2-nitrofluorene (1µg per plate) for TA98, sodium azide (1.5 µg per plate) for TA100 and TA1535, mitomycin (1 µg per plate] for TA102, and acridine mutagen (1 µg per plate) for TA1537. With metabolical activation: 2-aminoant

Results and discussion

Test results
Species / strain:
other: TA98, TA100, TA102, TA1535, TA1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Reverse Mutation Test Results for Phthalic Acid in Salmonella typhimurium:

 Compound  Concentration (µM)  S9  TA98  TA100  TA102  TA1535  TA1537
 Control   0  +  26.8 +1.6  101.2 +10.6  261.3 +14.3  8 +0.6  4 +0.5
   20  +  36.2 +1.8  158.6 +11.6  296.7 +15.4  13.6 +1.6  11.3 +1.6
   100  +  32.4 +1.5  148.6 +12.3  302.2 +16.8  16.2 +1.9  14.3 +1.4
   500  +  36.4 +2.1  152.9 +11.6  295.3 +12.5  14.4 +1.1  14.9 +1.1
   2500  +  29.7 +1.8  139.7 +10.3  297.6 +11.8  14.9 +1.1  13.7 +1.2
   12500  +  32.9 +1.5  154.2 +11.2  296.3 +10.8  15.3 +1.2  14.1 +0.9
 2 -AAa  1.0 µg/plate  +  402.3 +14.2  1278.5 +9.7  1358.2 +55.7  97.8 +2.8  75.5 +2.1
 Control  0  -  22.6 +2.5  114.3 +10.2  257.6 +9.8  9.2 +0.6  5.2 +0.6
   20  -  29.3 +0.9  162.3 +14.3  286.3 +10.8  16.8 +1.2  13.5 +1.2
   100  -  35.2 +2.4  156.8 +11.6  294.5 +9.3  18.5 +2.1  16.2 +2.1
   500  -  31.8 +1.5  165.4 +13.6  300.5 +11.7  17.4 +1.5  15.8 +1.4
   2500  -  29.8 +2.4  159.6 +9.7  298.8 +10.6  17.6 +1.8  15.2 +1.6
   12500  -  33.5 +1.9  160.8 +10.2  297.6 +12.1  15.9 +1.3  13.4 +1.6
 SAb  1.5 µg/plate  -    1172 +52.3    103.5 +11  
 MMCc  1.0 µg/plate  -      1256.9 +75.4  0  
ICR-191  1.0 µg/plate  -          88.5 +3.2
 2 -NFe  1.0 µg/plate  -  386.7 +15.9        

a2 -Aminoanthracene (2 -AA); bSodium azide (SA); cMitomycin C (MMC); dAcridine (ICR-191); e2 -Nitrofluorene (2 -NF).

Applicant's summary and conclusion

Executive summary:

The Ames Salmonella mutation test was used according to the plate incorporation procedure described by Maron and Ames (1983). Five Salmonella typhimurium strains were used: TA98, TA100, TA102; TA1535, and TA1537. This assay was performed with/without metabolic activation as an S9 mixture (Aroclor-1254 -induced rat liver homogenate). Negative and positive controls were used for each strain. The positive controls used in the tests performed without metabolic activation were as follows: 2 -nitrofluorene (1µg/plate) for TA98, sodium azide (1.5 µg/plate) for TA100 and TA1535, mitomycin (1µg/plate) for TA102, and acridine mutagen (1µg per plate) for TA 1537. The positive control used in the test performed with metabolic activation was 2 -aminoanthracene (1 µg per plate) for all strains. Five concentrations of the test substance were examined: 0; 20; 100; 500; 2500; 12500 µM using five bacterial strains and triplicate plates per dose. A significant increase in the number of revertants was observed in the presence of the positive control compounds. Negative and strain-specific positive control values were within historical lab range, demonstrating that the test conditions were effective and that the metabolic activation system functioned properly. The test substance did not produce mutagenic activity in any of the five bacterial strains tested under any of the activation conditions examined.