Registration Dossier
Registration Dossier
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EC number: 240-106-6 | CAS number: 15968-01-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
- Genetic toxicity in vitro: Bacterial reverse mutation assay:
1.- Key study: Read-across from experimental data on the analogue phthalic acid. Test method equivalent to OECD guideline 471. No data on GLP.
The test substance was found to be negative in this Ames assay (Salmonella typhimurium strains TA100, TA1535, TA97 and TA98 with and without metabolic activation).
2.- Key study: Read-across from experimental data on the analogue phthalic acid. Test method equivalent to OECD guideline 471. No data on GLP.
The test substance was found to be negative in this Ames assay (Salmonella typhimurium strains TA100, TA102, TA1535, TA1537 and TA98 with and without metabolic activation).
3.- Key study: Read-across from experimental data on the analogue phthalic anhydride. Test method equivalent to OECD guideline 471. No data on GLP.
The test substance was not mutagenic in the absence and presence of S-9 extracts (Salmonella typhimurium strains TA1537, TA1535, TA97 and TA98 with and without metabolic activation).
4.- Key study: Read-across from experimental data on the analogue phthalic anhydride. OECD guideline 471. GLP study.
The test substance did not induce mutations in the bacterial mutation test, neither in the absence, nor in the presence of metabolic activation (Salmonella typhimurium TA100, TA1535, TA98, TA1537 and E. coli WP2uvrA with and without metabolic activation).
- Genetic toxicity in vitro: Chromosomal aberrations in mammalian cells:
1.- Key study: Read-across from experimental data on the analogue phthalic acid. Test method equivalent to OECD guideline 473. No data on GLP.
The test substance did not produce chromosome aberrations in CHO cells and was not cytotoxic under the experimental conditions (with and without metabolic activation).
2.- Weight of evidence: Read-across from experimental data on the analogue phthalic anhydride. Test method equivalent to OECD guideline 473. No data on GLP.
Effects were observed only at the highest compound concentration which was "very toxic" (remaining cell counts 29%) and gave precipitate. Only a small, not statistically significant, increase in aberration was observed at a slightly lower concentration.
3.- Weight of evidence: Read-across from experimental data on the analogue phthalic anhydride. Test method equivalent to OECD guideline 473. No data on GLP.
The test substance did not produce chromosome aberrations in CHO cells at any dose tested (with and without metabolic activation).
4.- Key study: Experimental results obtained with the substance disodium phthalate. Test method equivalent to OECD guideline 473. No data on GLP.
The test substance showed no genotoxicity in this chromosomal aberration test in CHO cells.
- Genetic toxicity in vitro: Gene mutation in mammalian cells:
1.- Key study: Experimental results obtained with the substance disodium phthalate.
OECD guideline 476 and EU method B.17. GLP study.
The test item did not induce any toxicologically significant increases in the mutant frequency at the TK +/- locus in L5178Y cells and is therefore considered to be non-mutagenic under the conditions of the test (with and without metabolic activation).
- Genetic toxicity in vivo: Mammalian erythrocyte Micronucleus test:
1.- Key study: Read-across from experimental data on the analogue phthalic acid. Test method equivalent to OECD guideline 474. No data on GLP.
In general, MNPCE% was higher for mouse bone-marrow cells treated with the test agent, but no concentration-response relationship was observed. PCE/(PCE+NCE) values were also elevated in cells treated with the test agents, but no concentration-response relationship was found.
Justification for selection of genetic toxicity endpoint
No study was selected, since the results obtained in the in vitro studies (Ames test, chromosome aberrations test and mammalian cell gene mutation assay) and the results obtained in the in vivo studies (chromosome aberrations test) were negative.
Short description of key information:
- Genetic toxicity in vitro: Bacterial reverse mutation assay:
Read-across from experimental data on the analogues phthalic acid and phthalic anhydride.
Negative.
- Genetic toxicity in vitro: Chromosomal aberrations in mammalian cells:
Read-across from experimental data on the analogues phthalic acid and phthalic anhydride and experimental results obtained with the substance disodium phthalate.
Negative.
- Genetic toxicity in vitro: Gene mutation in mammalian cells:
Experimental results obtained with the substance disodium phthalate.
Negative.
- Genetic toxicity in vivo: Mammalian erythrocyte Micronucleus test:
Read-across from experimental data on the analogue phthalic acid.
Negative.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on the negative results obtained from the in vitro studies and the in vivo genetic toxicity studies, the substance is not classified for mutagenicity.
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