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Diss Factsheets

Administrative data

Description of key information

The key skin sensitisation study, conducted according to OECD TG 406, and in compliance with GLP, reports octadecan-1-ol to be not sensitising to skin in a guinea pig maximization test (Driscoll 1996; rel 1).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method. Furthermore, the LLNA test method is not considered to be suitable for fatty alcohols. Please refer to the attached document for further details.

Species:
other:
Strain:
Dunkin-Hartley
Route:
epicutaneous, occlusive
Vehicle:
other: arachis oil
Route:
epicutaneous, occlusive
Vehicle:
other: arachis oil
No. of animals per dose:
10
Details on study design:
1st application: Induction 1 % intracutaneous
2nd application: Induction 50 % occlusive epicutaneous
3rd application: Challenge occlusive epicutaneous
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
other: Evidence of reaction of the strain of guinea pigs to known skin sensitisers over an appropriate period was provided.

RESULTS OF PILOT STUDY: Minimal erythema at 24 and 48 hours after 48 hour topical exposure, no irritation at these time periods after a 24 hour 

topical application. Well defined erythema (grade 2) at 24, 48 and 72 hours post injection reducing to slight erythema (grade 1) at 7 days.

RESULTS OF TEST
- Sensitization reaction: No positive responses with 25% or 50% challenge concentrations in test or control groups at 24 or 48 hours. 0/10  treated and 

0/5 controls responded to challenge.
- Clinical signs: Body weights and weight gain over the observation period were comparable in test and control groups. Well-defined erythema was 

noted at the intradermal induction sites of all test group animals at 24 and 48hours. Very slight to well-defined erythema was noted at the 

intradermal sites of the control group at 24 and very slight erythema at 3 sites at 48 hours.
Very slight to well-defined erythema was noted at the induction sites of six test group animals at the 1 hour mark. No skin reactions were noted at 

the induction sites of any test group animals at the 24 hour mark.
- Rechallenge: Not carried out.

Interpretation of results:
GHS criteria not met
Conclusions:
Kalcol 8098 is not a skin sensitiser when tested using the Magnusson and Kligman guinea pig maximization procedure.

Executive summary:

In a skin sensitisation study, 1 % of test material in arachis oil was injected intracutaneously at day 1 from the study period in 10 guinea pigs (intradermal induction phase). At induction phase, 50 % of test material in arachis oil was applied epicutaneously onto the skin of the test animals and kept in contact to the skin under occlusive dressing for 48 hours.

Following challenge exposure (at day 21), 25 and 50 % of test material in arachis oil was applied onto the same test area and kept under occlusive dressing fro 24 hours.

No positive responses with 25% or 50% challenge concentrations in test or control groups at 24 or 48 hours. 

Body weights and weight gain over the observation period were comparable in test and control groups. Well-defined erythema was 

noted at the intradermal induction sites of all test group animals at 24 and 48hours. Very slight to well-defined erythema was noted at the 

intradermal sites of the control group at 24 and very slight erythema at 3 sites at 48 hours.
Very slight to well-defined erythema was noted at the induction sites of six test group animals at the 1 hour mark. No skin reactions were noted at 

the induction sites of any test group animals at the 24 hour mark. The test material was reported to be not sensitising under the conditions of the study. The study was conducted according to the appropriate OECD guideline and in compliance with GLP.

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

The key skin sensitisation study was the most recent and available study, conducted according to the appropriate OECD guideline and in compliance with GLP.

In the skin sensitisation study, 1 % of test material in arachis oil was injected intracutaneously at day 1 from the study period in 10 guinea pigs (intradermal induction phase). At induction phase, 50 % of test material in arachis oil was applied epicutaneously onto the skin of the test animals and kept in contact to the skin under occlusive dressing for 48 hours.

Following challenge exposure (at day 21), 25 and 50 % of test material in arachis oil was applied onto the same test area and kept under occlusive dressing fro 24 hours.

No positive responses with 25% or 50% challenge concentrations in test or control groups at 24 or 48 hours. 

Body weights and weight gain over the observation period were comparable in test and control groups. Well-defined erythema was 

noted at the intradermal induction sites of all test group animals at 24 and 48hours. Very slight to well-defined erythema was noted at the 

intradermal sites of the control group at 24 and very slight erythema at 3 sites at 48 hours.
Very slight to well-defined erythema was noted at the induction sites of six test group animals at the 1 hour mark. No skin reactions were noted at 

the induction sites of any test group animals at the 24 hour mark. The test material was reported to be not sensitising under the conditions of the study.

Discussion of trends in the Category of C6-24 linear and essentially-linear aliphatic alcohols:

There is evidence throughout the carbon number range C6-C24 that long chain alcohols are not sensitising; this conclusion does not vary with carbon number within the Category: read-across substances are chosen based on carbon chain length and similarity of physicochemical properties.

A mouse local lymph node assays (LLNA) performed with Alcohols C14-15 branched and linear and with Alcohols C16-17 branched and linear was positive, although this study, which has significant deficiencies in terms of methodology and presentation of results, may have been confounded by skin irritation (House 2000). The LLNA studies pre-date the guideline, OECD TG 429, which indicates that for certain classes of substances, the LLNA may give false positives, and refers to Basketter et al (2009). This paper presents information on two fatty alcohols, and concludes that the fatty alcohols are not sensitisers, and may give a true false positive in the local lymph node assay. For such substances, use of the guinea pig maximisation assay is recommended. Data from guinea pig maximisation assays are available for a number of constituents of the substance and for multi-constituent substances with similar composition; the majority of these studies gave clear negative results. Therefore no classification is proposed for sensitisation, and the Category conclusion is that the members of the C6-24 alcohols category are not sensitisers.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the above information, octadecan-1 -ol does not require classification for skin sensitisation, according to Regulation (EC) No 1272/2008.