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. 2020 Mar 9;18(3):e05991. doi: 10.2903/j.efsa.2020.5991

Table 18.

Genotoxicity studies on long‐chain chlorinated paraffins

Compound Type of test Experimental system Exposure conditions Result Comments Reference
C23, 43% chlorination Reverse mutation assay S. TyphimuriumTA 97, TA 98, TA 100, TA 1535 Up to 10,000 μg/plate+/− S9 (rat and hamster liver) Negative
  • –

    20‐minute pre‐incubation period

  • –

    No cytotoxicity observed

  • –

    Precipitation not reported

 NTP (1986b)
Cereclor 42(C20–30, 42% chlorination) Reverse mutation assay S. TyphimuriumTA 98, TA 100, TA 1535, TA 1538 Up to 2,500 μg/plate+/− S9 (rat liver)Neg. control: DMSOPos. control: 1,3‐propanesultone and 2AA Negative
  • –

    No cytotoxicity observed

  • –

    Precipitation not reported

 Birtley et al. (1980)
C23, 43% chlorination Chromosomal aberration test Chinese hamster ovary cells −S9:First experiment: 0, 1,250, 2,500, 5,000 μg/mL Exposure: 8 h, harvesting: 2–2.5 h laterSecond experiment: 0, 3,784, 4,400, 5,000 μg/mL+S9 (rat liver):0, 2.513, 3,750, 5,000 μg/mLExposure: 2 h, harvesting: 8–10 h laterNeg. control: acetonePos. control: −S9: MMC, +S9: cyclophosphamide

−S9:First experiment:Significant increase at 5,000 μg/mL, no concentration response relationshipSecond experiment:Significant increase at 5,000 μg/mL, clear concentration response relationship+S9:No increase CA

Positive without metabolic activation

Cytotoxicity not reported,Oily droplets formed at doses > 157 μg/mL Anderson et al. (1990)
C23, 43% chlorination SCE Chinese hamster ovary cells −S9:First experiment: 0, 0.5, 5.0, 5,000 μg/mL,Second experiment:0, 5.0, 1,700 and 5,000 μg/mL+S9 (rat liver):0, 5.0, 500, 1,700 and 5,000 μg/mL

First experiment:−S9:Significant increase at 5,000 μg/mL, concentration response relationshipSecond experiment:Significant increase at all three concentrations, concentration response relationship+S9:Significant increase at all four concentrations, concentration response relationship up to 500 μg/mL, at the two highest concentrations induction of SCE was lower than at 500 μg/mL

Positive

Cytotoxicity not reported Anderson et al. (1990)
C22–26, 43% chlorination In vivoChromosomal aberrationBone‐marrow cells Male F344 rats 8 animals/groupGavage, daily for 5 days0, 500, 1,500 or 5,000 mg/kg bw per dayNegative control: corn oil. Positive control: cyclophosphamide

No signs of toxicityNo increased frequency of chromosomal aberrations, excluding gaps detected in samples taken at day 6

Negative

  • –

    Incidence of chromosomal gaps not assessed

  • –

    No other sampling times

  • –

    Cytotoxicity not assessed and therefore, no indication of whether or not the test substance reached the bone marrow

 IRDC (1983i)Unpublished study, see Documentation provided to EFSA
C20–30, 70% chlorination In vivo Chromosomal aberration Bone‐marrow cells F344 rats 8 animals/groupGavage, daily for 5 days0, 500, 1,500 or 5,000 mg/kg bw per day

bw gain decreased in high‐dose animalsNo increased frequency of chromosomal aberrations

Negative

Cytotoxicity not reported and therefore, no indication of whether or not the test substance reached the bone marrow IRDC (1983, as cited by WHO/IPCS, 1996)

bw: body weight; SCE: sister chromatid exchange.