Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Information is available on the skin sensitisation potential of the following members of this category:

 

Test substance identity

Technique

Adjuvant-based method

Non-adjuvant-based method

Hex-1-ene

 

v

Alkenes, C6-8 (aka Alkenes, C6-8, even and odd, linear and branched)

v

 

Oct-1-ene

 

v

Alkenes C11/C13/C14 (aka tridecene) (aka Alkenes C13-14)

v

 

Alkenes C11-15 (aka tetradecene)

v

 

Alkenes, C12-14 a-

 

v

hexadec-1-ene - MC

 

v

Alkenes, C16-18

 

v

Octadec-1-ene - MC

 

v

Dodec-1-ene

 

v

Alkenes, C20-24 a-

 

v

Alkenes, C20-24 (aka C20-C22 (even numbered, linear and branched) and C24(branched) alkenes)

v

 

 

Details of these investigations are discussed below.

Information is available from one study that has investigated the skin sensitisation potential of 1-hexene and the related substance alpha olefin C6.

In a skin sensitization study 1-hexene (Neodene 6 alpha olefin) was tested in Duncan Hartley guinea pigs (5 animals/sex) using a patch sensitisation method (Cagen and Lam, 1982). Animals were exposed to 0.5 millilitres test material, 2,4-dinitrochlorobenzene (positive control), or ethanol (vehicle control) for 1 day/week for 6 hours/day for 3 weeks. For the three weekly initiating doses, a 1% solution of 1-hexene in ethanol was used; the primary challenge dose was also 1% 1-hexene in ethanol.  Reactions were scored with a numerical grade to indicate severity.  The positive control and vehicle control provided the appropriate response. Body weight gain was not affected by treatment. 1-hexene caused little or no irritation after the initiation or challenge dose and did not induce a delayed contact hypersensitivity reaction under the conditions of the study.  It was concluded that 1-hexene was not a dermal sensitiser.

Information is available from one study that has investigated the skin sensitisation potential of alkenes, C6-8.

In a skin sensitization study, alkenes, C6-8 (SHOP C68) was administered to 20 test and 10 control Dunkin-Hartley guinea pigs (Rees, 1996). The following doses were selected based on a range-finding experiment: 50% in paraffin oil for the intradermal induction; 100% for the topical induction; and 100% and 30% in paraffin oil for the challenge phase. During the challenge phase, 16 test animals and 4 control animals exhibited a positive response to 100% alkenes, C6-8. At 30% alkenes, C6-8, 5 test animals and no control animals exhibited a positive response. Only one test animal showed a positive response to paraffin oil alone during the challenge phase. Based on these responses, a re-challenge was conducted with 50% alkenes, C6-8. Two test animals and 1 control test animals exhibited a positive response. Again, one test animal showed a positive response to paraffin oil during the challenge phase. Based on these results, alkenes, C6-8was not determined to be a skin sensitiser.

Information is available from one study that has investigated the skin sensitisation potential of 1-Octene and the related substance alpha olefin C8.

In a skin sensitization study, 1-octene (Neodene 8 alpha olefin) was tested in Hartley albino guinea pigs (5 animals/sex) (Lam and Angevine, 1983). Animals were exposed to 0.5 millilitres test material, 2,4-dinitrochlorobenzene (positive control), or ethanol (vehicle control) for 1 day/week for 6 hours/day for 3 weeks. For the three weekly initiating doses, a 1% solution of 1-octene in ethanol was used; the primary challenge dose was also 1% 1-octene in ethanol.  Reactions were scored with a numerical grade to indicate severity.  The positive control and vehicle control provided the appropriate response. Body weight gain was not affected by treatment. 1-octene caused little or no irritation after the initiation or challenge dose and did not induce a delayed contact hypersensitivity reaction under the conditions of the study.  It was concluded that 1-octene was not a dermal sensitizer.

Information is available from one study that has investigated the skin sensitisation potential of 1-dodecene and the related substance alpha olefin C12.

In a skin sensitisation study 1-dodecene (Neodene 12 alpha) was evaluated in young Hartley albino guinea pigs (10 animals/sex) for dermal sensitisation potential using the method of Buehler (Morris, 1992). Animals were exposed to 0.3 millilitres test material for 1 day/week for 6 hours/day for 3 weeks. Following a 2 week rest period, animals received a challenge dose in the same manner as the initiating doses.  For the three weekly induction doses, a 10% W/V solution of 1-dodecene in acetone was used; the primary challenge dose was a 5% W/V solution of 1-dodecene in acetone.  Reactions were scored with a numerical grade to indicate severity. Challenge of the test material resulted in a 24 -hour severity score of 0.3 for both test and naive control animals. The 48-hour scores for test and naive control animals were 0.2 and 0.05, respectively. Historical laboratory data indicated that the positive control substance, 2,4-dinitrochlorobenzene produced the appropriate response as in previous studies. It was concluded that 1-dodecene was not a dermal sensitizer since the graded dermal responses were not significantly different between the test and control animals.

Information is available from one study that has investigated the skin sensitisation potential of Alkenes, C11/13/14.

In one skin sensitisation study (Rees, 1996), alkenes, C11/13/14 (SHOP C134) in propylene glycol was administered to albino Dunkin-Hartley guinea-pigs (10 male/10 female). Animals were tested by the Magnusson-Kligman Maximisation Test. Twenty guinea pigs (10 male; 10 female) received an intradermal injection of 50% alkenes, C11/13/14 in propylene glycol. Seven days later the animals were dermally treated in the same area with 100% alkenes, C11/13/14 (as supplied) and the site was covered with an occlusive dressing for 48 hours. A challenge dose of either 1% or 0.3% alkenes, C11/13/14 in propylene glycol was dermally administered on day 22, again with occlusive dressing. Test sites were then assessed 24 and 48 hours later. The intradermal injection of 50% alkenes C11/13/14 in propylene glycol caused slight to moderate erythema and discoloration. Undiluted alkenes C11/13/14 applied dermally caused exfoliation and loss of flexibility. After the challenge dose, 3 of 10 controls and 6 of 20 test animals treated with 1% alkenes C11/13/14 had slight erythema. There were no reactions after challenge with 0.3% alkenes C11/13/14 or propylene glycol. Under the conditions of this study, repeated applications of alkenes C11/13/14 did not cause delayed contact hypersensitivity in the guinea-pig.

Information is available from one study that has investigated the skin sensitisation potential of Alkenes, C11-15.

In a study, alkenes, C11-15 (Internal Olefin 114 LP11) in corn oil was administered to 10 male and 10 female guinea pigs using the method of Magnusson and Kligman (Cassidy and Clark, 1977). Using a scoring method of -ve, trace, +ve, and ++ve, erythema responses to the topical challenge dose was tabulated. Based on these results, alkenes, C11-15 not a dermal sensitiser.

Information is available from one study that has investigated the skin sensitisation potential of alkenes C12-14 alpha.

In a study assessing the dermal sensitisation potential of a C12-16 alpha olefin using the Landerstein method, male guinea pigs (10) were exposed dermally treated to 0.1 millilitres of alkenes C12-14 ? (C12-16 alpha olefin blend), undiluted, 2,4-dinitrochlorobenzene (0.5 % in ethanol, positive control), or 50% ethanol (vehicle control) on lightly abraded skin 3 times a week for a total of 9 applications (Rinehart, 1967).  Following 2 weeks of rest, animals received a challenge dose. One animal treated with C12-16 developed very slight erythema after the 7thexposure, while 2 animals exhibited slight erythema after 8 exposures. During the 2 week rest period, prior to challenge dose application, all animals recovered and displayed no further signs of erythema. No dermal response was observed in any of the animals challenged with alkenes, C12-14 alpha. The positive control produced an appropriate response. Based on the test results, alkenes, C12-14 alphs is not considered skin sensitisers in guinea pigs.

Information is available from one study that has investigated the skin sensitisation potential of 1-hexadecene and the related substance alpha olefin C16.

In a skin sensitization study, 1-hexadecene (Neodene 16) was evaluated in young adult Hartley guinea pigs for dermal sensitisation potential using the method of Buehler (Morris, 1992). Animals were exposed to 0.3 millilitres test material 1 day/week for 6 hours/day for 3 weeks. Following a 2 week rest period, animals received a challenge dose in the same manner as the initiating doses.  For the three weekly induction doses, a 10% W/V solution of 1-hexadecene in acetone was used; the primary challenge dose was a 2.5% W/V solution of 1-hexadecene in acetone.  Reactions were scored with a numerical grade to indicate severity. Challenge of the test material resulted in a 24 -hour severity score of 0.1 and 0.3 for test and naive control animals, respectively. The 48-hour scores for test and naive control animals were 0.05 and 0.2, respectively. Historical laboratory data indicated that the positive control substance, 2,4-dinitrochlorobenzene produced the appropriate response as in previous studies. It was concluded that 1-hexadecene was not a dermal sensitizer since the graded dermal responses were not significantly different between the test and control animals.

Information is available from two studies that have investigated the skin sensitisation potential of 1-octadecene.

In a skin sensitization study, Hartley albino guinea pigs (10/sex) were treated with 1-octadecene (Neodene 18 alpha olefin) using the Buehler Technique (Morris, 1992b). Animals were exposed to 0.3 millilitres test material 1 day/week for 6 hours/day for 3 weeks. Following a 2 week rest period, animals received a challenge dose in the same manner as the initiating doses.  For the three weekly induction doses, a 5% W/V solution of 1-octadecene in acetone was used; the primary challenge dose was a 2.5% W/V solution of 1-octadecene in acetone.  Reactions were scored with a numerical grade to indicate severity. There were no grades of 1 produced in the test or control animals. The incidence of grade + (numerical values of 0.5) responses in the test group (total 10 animals out of 19) was compared to the naïve control group (6 out of 10; one animal dead at the 48 hours observation period). The incidence and severity of responses in the test group were comparable to those produced by the naïve control group indicating that sensitisation had not been induced.  It was concluded that 1-octadecene was not a dermal sensitiser. 

In a human skin sensitisation study (Rheins, 1992b), 1-octadecene (Neodene 18 (25% in mineral oil)) was tested for the potential to induce contact sensitisation upon repeated application under semi-occlusive conditions. Sodium lauryl sulfate (0.1% in distilled water) was used for comparison. Reactions were scored with a numerical and letter grade to indicate severity and type of reaction. Only two of the thirty-one subjects exhibited mild erythema (which was resolved within 24 hours) during the induction phase compared to nine subjects exhibiting mild to moderate erythema after exposure to 0.1% sodium lauryl sulfate. Results indicate that 1-octadecene does not cause clinical irritation or sensitization in human subjects.

Information is available from one study that has investigated the skin sensitisation potential of alkenes C20-24 alpha.

In one skin sensitisation study alkenes C20-24 ? (Neodene C20-24 alpha olefin) was tested for its potential to induce skin sensitisation (delayed contact hypersensitivity) in male and female Harlan albino guinea pigs using the Buehler method (Morris, 1992). Animals were exposed to 0.3 millilitres test material 1 day/week for 6 hours/day for 3 weeks. Following a 2 week rest period, animals received a challenge dose in the same manner as the initiating doses.  For the three weekly induction doses, a warmed, undiluted alkenes, C20-24 ? (specified as undiluted in acetone) was used; the primary challenge dose was a 5% W/V solution of alkenes, C20-24? in mineral oil.  Reactions were scored with a numerical grade to indicate severity. Historical laboratory data indicated that the positive control substance, 2,4-dinitrochlorobenzene, produced the appropriate response as in previous studies. Alkenes, C20-24? caused little or no irritation after the challenge dose and did not induce a delayed contact hypersensitivity reaction under the conditions of the study. In this study, alkenes, C20-24? is not a dermal sensitiser.

Information is available from two studies that have investigated the skin sensitisation potential of Alkenes, C20-24.

Two studies are available that have investigated the skin sensitisation potential of alkenes, 20-24 (even numbered, linear and branched) using the Magnusson and Kligman maximization method. In the first investigation (Driscoll, 1998), 20 female guinea pigs test animals were induced using intradermal injections of Freund's Complete Adjuvant (FCA) plus distilled water; a 25% w/v formulation of test substance in arachis oil; and a 25% w/v formulation of test substance in FCA. One week later, topical induction involved application undiluted alkenes, 20-24 to the injection site for 48 hours under an occlusive wrap. Animals were challenged 21 days later using 100% and 50% test substance (diluted in arachis oil) applied to opposite flanks under occlusion for 24 hours. No skin reactions were noted at the challenge sites of the test or control animals at the 24 and 48 hour observation period. There were no changes in animal body weights during course of the study. Based on these results, it was concluded that test material produced a 0% (0/20) sensitization rate in the female albino guinea pigs.

In the second study Richeux (2008), conducted using a similar protocol, intradermal induction involved injection of FCA plus isotonic sodium chloride; 100% alkenes, 20-24; and a 50% formulation of test substance and FCA. One week later, the injection site of all test and control animals was treated with 10% sodium lauryl sulfate in thick vaseline, followed by topical application of 100% test substance under occlusion for 48 hours. Animals were challenged with 12.5% and 6.25% test substance in liquid paraffin applied to opposite flanks under occlusion for 24 hours. No skin reactions were noted at the challenge sites of the test or control animals at the 24 and 48 hour observation period. Body weight increases in the test group were comparable to those noted in the control group over the course of the study. Based on these results, it was concluded that alkenes, 20-24 was not a skin sensitiser in female albino guinea pigs.

Information is also available from a modified Buehler sensitisation study conducted on tridecene (Varsho, 1995), a substance that is not part of this category. It is included here for completeness. Following induction and challenge, no evidence of sensitisation was observed while the positive control produced the expected results. Tridecene is not a sensitiser under the conditions of this investigation.


Migrated from Short description of key information:
Not a skin sensitiser, based on animal test data.

Justification for selection of skin sensitisation endpoint:
Dermal sensitization testing has been conducted on 11 members of this category ranging from C6 to C20-24. Information is also available for triecene, a chemically related non-category member. Testing was normally performed in the guinea pig, using both adjuvant and non-adjuvant based methods, however one human repeated insult patch test is also available (1-octadecene). These was no evidence of dermal sensitization in any of these studies.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
Not expected to cause respiratory sensitisation based on results of skin sensitisation testing and an absence of reactive chemical alerts.

Justification for classification or non-classification

Dermal sensitization testing has been conducted on 11 members of this category, ranging from C6 to C20-24. Information is also available for triecene, a chemically related non-category member. Testing was normally performed in the guinea pig, using both adjuvant and non-adjuvant based methods, however one human repeated insult patch test is also available (1-octadecene). There was no evidence of dermal sensitization in any of these studies, and no classification is necessary according to the CLP regulation.