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

Endpoint summary

Description of key information

Based on read-across using the analogue approach, Distillates (Fischer-Tropsch), 210-360 degree Celsius, hydrotreated, isoalkanes, cyclics, <0.1% aromatics are not considered to be irritating to the skin and the eyes.
Skin: not irritating; 
Eye: not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

There are no data available on skin and eye irritation 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).

 

Skin irritation

The skin irritation study was performed in accordance with OECD 404 (Cepsa Química, 2000). The unchanged test substance (hydrocarbons, C11-C14, n-alkanes, < 2% aromatics) was applied using a gauze patch to the shaved skin of three rabbits for 4 h under semi-occlusive conditions. After treatment, the gauze patch was removed and the treated skin site was cleaned. Dermal responses were evaluated at 24, 48, and 72 h after patch removal. Well defined erythema and slight oedema followed exposure and were resolved by day 13. The average erythema score (24, 48, and 72 hours) was 1.9. The average edema score (24, 48, and 72 hours) was 1.1. Under the test conditions, the test substance was not irritating to the skin. In another study, hydrocarbons, C11-C14, n-alkanes, < 2% aromatics wereadministered via a semi-occlusive patch for 4 h to 3 female rabbits to assess the dermal irritation potential (Petrochem Carless Limitied, 1997).  Dermal responses were evaluated at 1, 24, 48, and 72 h post-dosing according to the Draize method of scoring.The average erythema score (24, 48, and 72 hours) was 0.55. The average edema score (24, 48, and 72 hours) was 0.66.

Hydrocarbons, C12-C16, n-alkanes, isoalkanes, cyclics, < 2% aromatics were administered via a semi-occlusive patch for 4 h to 6 rabbits to assess the dermal irritation potential of the test substance (ExxonMobil, 1990). After treatment, the gauze patch was removed and the treated skin site was cleaned. Dermal responses were evaluated at 24, 48, and 72 h after patch removal. Well-defined erythema (4/6) and very slight erythema (2/6) were noted at 24 h observation. All erythema scores were fully reversible within 7 days. No edema scores were observed in any animal. The mean erythema and edema scores for the test substance were 1.0 and 0, respectively.

In a primary dermal irritation study conducted according to OECD 404, 6 rabbits were dermally exposed to 0.5 mL of hydrocarbons, C14-C19, isoalkanes, cyclics, < 2% aromatics (ExxonMobil, 1995). Test sites were covered with a semi-occlusive dressing for 4 h. The skin reactions were evaluated at 24, 48 and 72 h after removal of the dressing. The mean scores for signs of erythema and edema after patch removal were 0.0. Under the test conditions, the test substance was not considered as irritating to the rabbit skin.

 

Human data on skin irritation

Hydrocarbons, C11-C14, n-alkanes, < 2% aromatics were administered via an occlusive dermal patch on the skin of 100 human (female) test subjects for 48 h (ExxonMobil, 1968). Clinical observations were made immediately after the patch was removed, 15 min, and 24 h after post-application.  In general minimal erythema was observed at the test site, with little to no noted edema.  This study should be used for supporting purposes only due to the prolonged 48 h exposure.  Based on the minimal erythema displayed by the test subjects the test substance was deemed to be a minimal dermal irritant.

In a clinical test including 15 human volunteers, isohexadecane was applied undiluted on upper arm under occlusive conditions (patch) for 24 h (Acklin, 1994). Skin reactions were scored 30 min and 24 h after removal of the patch. Mild signs of irritation were observed in only 3 volunteers and only slight signs of irritation in 8 volunteers in worse conditions (24-h exposure, occlusive conditions), leading to the conclusion that isohexadecane is not irritant for human skin.

The study of ExxonMobil (1988) included three phases which evaluated different propensities of hydrocarbons, C14-C19, isoalkanes, cyclics, < 2% aromatics. The first phase was only a preliminary test condition study. The phase II study was performed in order to determine the phototoxicity and the primary irritancy propensities of the test substance in human skin. The preliminary Phase I study was conducted to determine the Minimum Erythemogenic Dose (MED) for each member of a group of thirty panelists when the skin is irradiated by UV-B light. The least duration of UV-B exposure which produced erythema of Grade 1 or greater was selected as the MED value for each panelist. One volunteer was dropped out at the end of the phase II of the study. The Phase II study was performed with a panel of 30 volunteers. The test substance was diluted at 50% w/w in petrolatum and 0.3 g of solution were applied to skin of volunteers under semi-occlusive patches for a period of 24 h. The control site was also covered with a similar semi-occlusive bandage without test substance. After exposure, skin examinations were conducted. After first exposure, participants received 0.3 g of undiluted test substance (or water for negative control site) on the same sites, which was removed after 10 min. Then, for the phototoxicity determination, the right arm was exposed to 15 min UV-A followed by 1 MED of UV-B. The left arm was not exposed to UV to determine the primary irritancy. Both arms were examined for dermal irritation at 24, 48 and 72 h after exposure. Skin reaction was not observed in any subjects. Under the test conditions, test substance did not elicit any effects which could be construed as characteristic of a phototoxic propensity or a primary irritant.

In conclusion, taking into account all available data, classification as skin irritant is not warranted, but repeated or prolonged contact of hydrocarbon fluids with skin may cause defatting and drying of the skin.

 

Eye irritation

0.1 mL of hydrocarbons, C11-C14, n-alkanes, < 2% aromatics (Petrepar 134 (60/40) were administered to the right eye of 3 rabbits to assess occular irritation according to OECD 405 (Cepas Química, 2000). Irritation and toxicity were monitored at 1, 24, 48, and 72 h post-treatment. Irritation was scored according to the Draize methodology. No corneal damage or iridial inflammation was observed. Hyperaemia of blood vessels of the conjuctivae was seen in all animals. Ocular reactions had resolved in all instances by one day after instillation. The mean conjunctivae, chemosis, iris, and cornea scores for the test substance were 0.0, 0.0, 0.0, and 0.0 respectively. Based on the data, classification as an ocular irritant is not warranted. The eye irritant effect of hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, < 2 % aromatics (DV 98-25) were investigated according to the OECD 405(Kaaber, 1998).Three female rabbits were exposed to 0.1 mL of the test substance in the left eye. The eyes were examined and the changes were graded according to a numerical scale 1, 24, 48 and 72 h after dosing.Minimal conjunctival irritation (redness) was observed in the three rabbits 1 h after dosing. During the rest of the observation period no abnormalities were observed for two animals while redness (score 1) was still observed up to 48 h in the third animal. At the 72 h reading time point,mean conjunctivae, chemosis, iris, and cornea scores for the test substance were 0.0, 0.0, 0.0, and 0.0 respectively.The test substance is not considered as irritating to the eyes. The eye irritant effect ofparaffin (petroleum), normal, C5-C20 (MRD-83-207) was investigated similar to OECD 405 (Plutnick, 1983). Six albino rabbits were exposed to 0.1 mL of the test substance in the right eye. The eyes were examined and the changes were graded according to a numerical scale 1, 4, 24, 48 and 78 h after instillation and once per day on Day 4 and 7. The eyes were not rinsed after administration of the test substance. No corneal and iridal lesion was observed throughout the observation period. Ocular exposure to the test substance only resulted in conjunctival redness (score 1 and 2 in all animals at 1 h and 4 h after instillation; then, slight redness was only observed in 5 animals at 24 h). The eyes were clear of irritation by 48 h in all animals: the mean score was 0.27 for conjunctival redness. The test substance is not considered as irritating to the eyes.

In conclusion, the available studies indicated that the read-across substances had eye irritation scores but well-below the threshold for classification.

Justification for classification or non-classification

Based on read-across within an analogue approach, the available data on skin and eye irritation 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.