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

Endpoint summary

Description of key information

Oral (OECD 401), rat: LD50 > 5000 mg/kg bw
Inhalation (OECD 403), rat: LC50 > 4951 mg/m3 
Dermal (OECD 402), rat, rabbits: LD50 > 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

There are no data available on acute toxicity (oral, inhalation and dermal) of Distillates (Fischer-Tropsch), 210-360 degree Celsius, hydrotreated, isoalkanes, cyclics, <0.1% aromatics.

Distillates (Fischer-Tropsch), 210-360 degree Celsius, hydrotreated, isoalkanes, cyclics, <0.1% aromatics consist of hydrocarbon solvents with predominant carbon numbers in the range of C11 to C19. The constituents of this solvent are single isomers as well as mixed solvents of which the primary constituents are branched chain (iso-), and cyclic aliphatic hydrocarbons. Aromatic constituents, if present, represent less than 0.1% of the total volume.

N-paraffins are only present in very low concentrations (<1%).

The carbon numbers in the range of C11 to C19 and initial distillation points (IBP) characterize the source substances. The distillation range of the source substances ranges from 220°C to 350 degree Celsius although some solvents may contain higher boiling material. The benzene and sulphur contents of source substances are low, benzene levels for example are typically <3 ppm.

The toxicology and environmental fate and effects data show that source substances have a similar order of (eco-)toxicological and environmental fate properties as the target substance. Therefore, read-across is performed based on an analogue approach (for details please refer to the analogue justification which is attached in section 13 of the technical dossier).

 

Oral:

Conducted similar to OECD 401, acute oral toxicity of hydrocarbons, C11-C14, isoalkanes, cyclics, < 2% aromatics was evaluated in rats via gavage at 5000 mg/kg bw (ExxonMobil, 1989). All animals survived the end of the study period, but showed piloerection within 5 min of dosing. Recovery of clinical signs was completed by day 2. At autopsy, no abnormalities were found. The LD50 was determined to be > 5000 mg/kg bw. In another oral acute toxicity study, hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, < 2% aromatics were administered to rats up to 15000 mg/kg bw (Exxon Mobil, 1977). No mortality occurred, but during the first 24 h after dosing, hyperactivity to noise, dilated pupils, and slight lethargy were observed. Chromorhinorrhea was noted in 4 males and 1 female on day 1 after exposure and slight alopecia in the anogenital area was observed in 9/10 animals after exposure. At necropsy, darkened ovaries and some darkened parts of the uterus were found. The oral LD50 was > 15000 mg/kg.

Hydrocarbons, C14-C16 (n-Paraffins) were tested for acute oral toxicity in rats (Moulton, 1982). Animals were fasted overnight prior to treatment. The test substance was administered with doses of 4750 mg/kg bw or 5250 mg/kg bw. One male died at the lowest test substance dose while no mortality was observed at the highest dose. Hypoactivity of the animals was observed within 24 h post-treatment but not thereafter. Diarrhea, diuresis, wet skin and fur of anogenital region and general weakness were also noted at both doses within one to three days post-treatment. At necropsy, macroscopic examination of main organs showed no abnormalities. Under the test conditions, the acute oral LD50 was found > 5250 mg/kg bw.

Hydrocarbons, C14-C17, n-alkanes, < 2% aromatics were tested for acute oral toxicity in rats (Kynoch, 1984). The assay was conducted with a dose of 5000 mg/kg bw administered by gavage. No deaths occurred. Piloerection was observed in all animals shortly after dosing but not at 72-hour observation period. At necropsy, macroscopic examination of main organs showed no abnormalities. The acute oral LD50 was determined to be > 5000 mg/kg bw.

Also Paraffin (normal, C5-C20) was tested for acute oral toxicity in rats (ExxonMobil, 1983). The animals were administered with 5000 mg/kg bw. No deaths were noted during the study. A/G staining was noted in 9/10 animals at the 4 h observation and in all animals at the 6 h observation. Unkempt coat was observed in 2 males and 4 females on the day 1 observation. At necropsy, macroscopic examination of main organs showed lung discoloration in 7 animals. The acute oral LD50 was found to be > 5000 mg/kg bw.

In conclusion, there are four studies available for acute oral toxicity, dealing with the toxicity of hydrocarbons, C11-C14, C14-C16 and C14-C17. All studies were conducted similar to OECD 401 with or without GLP compliance and indicated a LD50 value of > 5000 mg/kg bw in rats.

 

Inhalation:

To assess acute inhalation toxicity, rats were exposed to hydrocarbons, C11-C13, isoalkanes, < 2% aromatics, similar to OECD 403 (ExxonMobil, 2005). The test substance was administered via whole body inhalation for 4 h at the maximum attainable vapour concentration of 4951 mg/m³. All rats survived and appeared normal during exposure and the 14 day post-exposure period. There were no gross pathological alterations noted in any of the animals. The LC50 was > 4951 mg/m³.

Similar to OECD 403, hydrocarbons C12-C16, isoalkanes, cyclics, < 2% aromatics were administered via whole body inhalation for 4 h to rats at an analytical chamber concentration of 5991 mg/m³. No mortality occurred, but during exposure wet/matted fur, decreased activity and closed eyes were observed. All animals recovered by the first day post-exposure, with the exception of one male that displayed anogenital staining and wet and matted fur and one female that showed anogenital staining. From day 2 to study termination, one male exhibited a necrotic and truncated tail, and one male and one female displayed scabs. No macroscopic abnormalities at post-mortem examination were noted. The LC50 was determined to be > 5991 mg/m³.

In conclusion, there are two studies available for acute inhalation toxicity, dealing with the toxicity of hydrocarbons, C11-C13 and C12-C16, < 2% aromatics. Both studies were conducted similar to OECD 403 with or without GLP compliance and resulted in LC50 values of > 4951 mg/m³ in rats.

 

Dermal:

Rats were exposed to 2000 mg/kg bw hydrocarbons, C11-C14, isoalkanes, cyclics, < 2% aromatics for 24 h using an occlusive patch (Cepsa Química, 1989). All animals survived the end of study. Well-defined erythema accompanied by slight oedema were observed in 5/5 males and 1/5 female after removal of the dressings. Slight erythema were observed in the remaining four females. All skin irritation reactions had resolved by day 4 of the study. The LD50 was > 2000 mg/kg.

5000 mg/kg bw hydrocarbons, C11-C14, n-alkanes, < 2% aromatics were dermally administered to rabbits for 24 h using an occlusive patch (ExxonMobil, 1993). All animals survived the exposure. Well-defined erythema were noted upon removal of the test patches in 3/3 animals. Edema were noted in 2/3 animals. At Day 14, three animals were noted as having very slight erythema and only one animal was noted as having well-defined erythema. 5 animals showed desquamation. The LD50 was > 5000 mg/kg.

Hydrocarbons, C14-C17, n-alkanes, < 2% aromatics were tested for acute dermal toxicity in rats according to OECD 402 (Kynoch, 1984). The assay was conducted with a limit dose of 2000 mg/kg bw. After application, an occlusive patch was held in place for 24 hours. No deaths and clinical signs occurred during the observation period. Slight to well-defined and slight oedema were observed at the site of treatment in all animals. Reversibility was generally observed by day 6 with the exception of one animal showing slight oedema until day 9. All rats developed small, slightly raised erythematous areas at the dose site on the day 6. Small focal scab formations persisted from day 9 to day 15 in all rats except two females which had recovered by day 14. Two small areas of necrosis were observed at the treatment site on two males on day 2, but recovered on day 6 and day 9, respectively. Under the test conditions, the LD50 was > 2000 mg/kg bw.

Paraffin (normal C5-C20) was tested for acute dermal toxicity in rabbits similar to OECD 402 (ExxonMobil, 1983). The assay was conducted with a dose of 3160 mg/kg bw. The test substance was applied for 24 h using an occlusive patch. No deaths occurred during the observation period. Moderate to severe erythema were observed in all rabbits at the end of exposure while very slight edema were only observed in one animal. No edema were observed in any rabbits. At the end of 14 day observation period, very slight erythema was still recorded in two females. The LD50 was > 3160 mg/kg bw.

The studies available for acute dermal toxicity dealt with the toxicity of C11-C14 n-alkanes, C14-C17 n-alkanes and paraffins (normal C5-C20). All studies were conducted similarly to OECD 402 with and without GLP compliance. All studies showed no mortality at concentrations equal to or higher than 2000 mg/kg bw in rats or rabbits.

Taking into account all available data on acute toxicity via the oral, inhalation or dermal exposure route, no hazard is expected However, based on physical and chemical properties (kinematic viscosity ≤ 20.5 mm²/s) of hydrocarbon fluids, the criteria for classification as aspiration hazard are met.

Justification for classification or non-classification

Based on read-across within an analogue approach, the available data on acute toxicity (oral, dermal and inhalation) do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.

However, based on the available data on physical and chemical properties (kinematic viscosity ≤ 20.5 mm²/s), hydrocarbon fluids meet the criteria for classification as aspiration hazard, Category 1 (H304) according to Regulation (EC) 1272/2008and as Xn, R65 according to Directive 67/548/EEC.