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

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

There are no data available on skin sensitisation 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).

 

Animal data

A Magnusson and Kligman Guinea pig maximization test (GPMT) was conducted similarly to OECD 406 with hydrocarbons, C11-C14, n-alkanes, < 2% aromatics (ExxonMobil, 1983a). Following a preliminary irritation test, guinea pigs were treated by intradermal injection (5.0% (v/v) vehicle or adjuvant/test substance) to induce sensitisation and then further sensitised by occlusive dermal application of 100.0% (v/v) test substance. Thereafter, the animals were challenged by occlusive topical application (0.5% (v/v) test substance in corn oil). Following topical challenge, 4/15 animals in both the treated and control groups displayed minimal irritation. Based on the scores of dermal irritation, the test substance would not be considered a dermal sensitizer under the test conditions. Under non-GLP conditions, another GPMT with hydrocarbons, C11-C14, n-alkanes, isoalkanes, cyclics, < 2% aromatics was conducted. The guinea pigs were treated by intradermal injection (0.1% (v/v) vehicle or adjuvant/test substance), sensitised by occlusive dermal application of 50.0% (v/v) test substance and thereafter challenged by occlusive topical application (25% (v/v) test substance in corn oil). The test substance was determined not to be skin sensitising (Shell, 1976), as there were no signs for skin irritation.

Hydrocarbons, C10-C13, n-alkanes, < 2% aromatics were also tested in the GPMT similar to OECD 406 (ExxonMobil, 1983b). The guinea pigs were treated by intradermal injection (5.0% (v/v) vehicle or adjuvant/test substance), sensitised by occlusive dermal application of 50.0% (v/v) test substance and thereafter challenged by occlusive topical application (0.5% (v/v) test substance in corn oil). Following topical challenge, 4/15 animals in both the treated and control groups displayed minimal irritation. Based on the scores of dermal irritation, test substance would not be considered a dermal sensitizer under the test conditions

 

Human data

Skin sensitisation studies performed according to human repeated insult patch tests (HRIPT) found no indication of skin sensitisation for the following compounds.

The sensitization potential of paraffin, normal, C5-C20 was assessed in a study conducted on 25 volunteers (Barsotti, 1995). Three subjects cancelled before the end of the study. The substance was diluted in mineral oil at 5%, 10%, 25%, 75% and applied under an occlusive patch chamber on site 1 to 4. Vaseline intensive Care Lotion was used as negative control (site 5) and Mineral oil as solvent control (site 6). The test substance was applied 5 days weekly for 21 days to the same site. There are 15 days of reading. All subjects received all test substance concentrations and both control substances. The delayed challenge is conducted at week 6. The used delayed challenge used was deemed as non-irritating concentration of Norpar 15. Readings are made at each patch removal site using a scale from score 0 to 4. During the 21-day induction phase, no subject developed reaction on test sites 1, 2, 3, and 6. Four subjects developed reaction on 75% concentration test site (site 4), two subjects showed a mean score of 1.5, one subject showed a mean score of 6 and one subject showed a mean score of 2.7. Six subjects developed a reaction at true negative control site (site 5): one subject had equivocal reaction (mean score 0.5) while the other subjects showed a mean score from 1 to 10. During challenging phase, no subject developed reaction on test site 1, 2, 3, 5, and 6 and only one subject developed a reaction (mean score 2) at 75% test substance site 4. On retest, this was negative. Under the occlusive patch test conditions, 75% of the test substance was a cumulative irritant. However, test substance did not induce allergic contact dermatitis. The study was performed by modification of the procedure set forth by Draize to determine the sensitisation potential of paraffin, normal, C5-C20 in 109 volunteers (Barsotti, 1996). Four subjects cancelled before the end of the study. The test substance was diluted at 25% in mineral oil. The skin occlusive plastic chamber patches were moistened with approximately 0.2 mL of 25% dilution test substance or mineral oil as solvent negative control and applied at different skin site. Patches are applied to the upper arms or backs of all panelists. The study was performed in approximately a six-week period for each subject. During the first three weeks considered as the induction period, patches are applied thrice weekly. All applications of test substance were made to the same site. Approximately two weeks after the induction phase, a single challenge application was performed by test substance patch application to a previous unpatched site. The challenge patches were removed 72 h following applications. Reactions to the challenge applications are scored at 96 h following applications. No subject showed any skin reaction during the induction or the challenging phase. Under the occlusive patch test conditions, test substance did not induce allergic contact dermatitis. The study of Kanengiser (2006a, 2006b, 2006c) was conducted in order to determine the dermal irritation and the sensitisation potential of hydrocarbons, C14-C18, n-alkanes, isoalkanes, cyclics, <2% aromatics in 53 volunteers. The test substance was diluted at 10% in petrolatum. Semi-occlusive patches were applied to skin of volunteers for a period of 24 hours. Prior to the application, the test area was wiped with 70% isopropyl alcohol and allowed to dry. After 9 applications during the induction period the sites were graded for dermal irritation. Following a 2-week rest period, the challenge patches were applied to previously untreated test sites on the back. After 24 hours, the patches were removed and the test sites were evaluated for dermal reactions. The test sites were re-evaluated at 48 and 72 hours. No skin reaction was observed in any subjects. Under the study conditions, the test substance did not demonstrate a potential for eliciting dermal irritation or sensitization.

Migrated from Short 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 skin sensitiser.
Guinea pig maximisation test (OECD 406): not skin sensitising

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Based on read-across within an analogue approach, the available data on skin sensitisation 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.