Distillates (Fischer-Tropsch), 210-360 degree Celcius, hydrotreated, isoalkanes, cyclics, <0.1% aromatics

Carcinogenicity

Description of key information

Based on all available data, there is no evidence of a carcinogenic potential for Distillates (Fischer-Tropsch), 210-360 degree Celsius, hydrotreated, isoalkanes, cyclics, <0.1% aromatics. Further testing is not required under Regulation (EC) 1907/2006, Annex XI, section 1.2.

Justification for classification or non-classification

Based on all available data, no carcinogenic potential is expected. The available data do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and therefore are conclusive but not sufficient for classification.

Additional information

There are no standard animal data available on carcinogenicity or on chronic toxicity of Distillates (Fischer-Tropsch), 210-360 degree Celsius, hydrotreated, isoalkanes, cyclics, <0.1% aromatics.

However, it can be assumed that Distillates (Fischer-Tropsch), 210-360 degree Celsius, hydrotreated, isoalkanes, cyclics, <0.1% aromatics have no carcinogenic potential based on the fact that surrogate substances were not shown to be mutagenic or clastogenic in the available genetic toxicity studies and bears no structural similarity to known carcinogens. Furthermore, Distillates (Fischer-Tropsch), 210-360 degree Celsius, hydrotreated, isoalkanes, cyclics, <0.1% aromatics did not produce any evidence of neoplasia in the available repeated dose toxicity studies. Moreover, all surrogates are poorly absorbed if ingested. They undergo metabolism, rapid excretion and low deposition; bioaccumulation of the test substance in the tissues is not likely to occur. Therefore, it is concluded that Distillates (Fischer-Tropsch), 210-360 degree Celsius, hydrotreated, isoalkanes, cyclics, <0.1% aromatics does not have a carcinogenic potential.

There are reliable data available for hydrocarbons, C10-C12, isoalkanes, < 2% aromatics (Stoddard solvent IIC) in female F344/N rats or in B6C3F1 male mice exposed to 2200 mg/m3. The NTP concluded there was equivocal evidence of carcinogenic activity of the test substance in female B6C3F1 mice based on increased incidences of hepatocellular adenoma. The NOAEC for male rats was determined to be 138 mg/m3. The incidences of benign pheochromocytoma in 550 and 1100 mg/m3 male rats and benign or malignant pheochromocytoma exceeded the historical chamber control ranges, suggesting that exposure to the test substance caused the increased incidences of these adrenal medulla neoplasms. The incidence of malignant pheochromocytoma was noted as 1 malignant tumor in control animals and 2 malignant tumors in 1100 mg/m3 male rats. However, the adrenal pheochromocytoma are not considered relevant to humans. The relevance of the pheochromocytoma in humans is equivocal at best. The increased incidences of adrenal pheochromocytoma that occurred in male rats are rarely observed in humans and other animals (Nyska, 1999; Hartwig, 2009). Pheochromocytomas that occur in animals by secondary mechanisms are not considered to be relevant to humans or should be used as a basis for classification (Hartwig, 2009). 

Similar findings were noted in the tests of normal paraffins. The tumor promotion activity was greatest in the treated groups displaying the highest degree of dermal irritation, i.e. 100% v/v normal paraffin test material. A low tumor incidence occurred in the groups receiving 50% or 28.6% /v normal paraffin test material (not statistically different from the control group), which correlated to low degrees of dermal irritation. The skin tumor promoting properties of these substances are considered related to repeated dermal irritation (Nessel, 1999).

 

Taking into account all available data, Distillates (Fischer-Tropsch), 210-360 degree Celsius, hydrotreated, isoalkanes, cyclics, <0.1% aromatics are not expected to be carcinogenic.

 

Literature not cited in the IUCLID:

Hartwig A, Reuter U, Richter-Reichhelm HB ,Thielmann HW.Chemically induced pheochromocytomas in rats: mechanisms and relevance for human risk assessment. Crit Rev Toxicol 2009; 39(8):695-718.

Nessel, Craig S, Freeman JJ, Forgash RC, and McKee RH. The Role of Dermal Irritation in the Skin Tumor Promoting Activity of Petroleum Middle Distillates. Toxicological Sciences 1999, 49, 48-55.

Nyska, A., Haseman, JK, Hailey JR, Smetana S, Maronpot RR. The association between severe nephropathy and pheochromocytoma in the male F344 rat - the National Toxicology Program experience. Toxicol. Pathol. 1999, 27, 456-462.