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EC number: 204-000-3
CAS number: 112-72-1
The key study for skin sensitisation, conducted according to OECD TG
406, and in compliance with GLP, reports tetradecan-1-ol to have no
sensitising potential to skin ( Drug and Safety Testing Center Co, 1997;
RESULTS OF RANGE FINDING STUDY:
Following intradermal injection, skin irritation was seen at concentrations of 10% and 5% persisting for 72 hours
but less marked at the lower concentration. The 3% concentration showed evidence of irritation at 24 hours in oneanimal only. Lower concentrations from 0.1 -1% showed no irritation. Following topical application slight
irritation was seen in 2/4 animals at 50% only.
TEST: There was no evidence of sensitisation in any of the test or control animals at either challenge concentration
Table 1. Summary of the delayed
contact hypersensitivity study of KALCOL 4098 in female guinea-pigs
Number of animals showing positive reaction/Total number of animals
24 hrs after challenge
48 hrs after challenge
The key study was the most recent and high reliability study available.
In the study, diluted test material in liquid paraffin was tested in 10
guinea pigs. Control group consisted of 5 animals ( Drug and Safety
Testing Center Co, 1997).
At induction phase, 0.1 ml of 5% (w/w) of test material in liquid
paraffin was applied intracutaneously as intradermal injection. 7 days
later, 0.2 ml of 50 % (w/w) was applied epicutaneously to the test area
and kept in contact to the skin under occlusive dressing for 48 hours.
At challenge phase (21 days after induction), 0.1 ml of 3% and 10 %
(w/w) of test material in liquid paraffin were applied onto the skin of
the test animals and kept in contact under occlusive dressing fro 24
Skin reaction scores were evaluated at 24 and 48 hours after challenge.
No skin reactions were noted at 24 and 48 hours observations. The test
material was reported to be not sensitising under the conditions of the
study. The study was conducted according to an appropriate OECD test
guideline, and in compliance with GLP.
A reliability 4 supporting study in human supports the findings of the
key study (Opdyke, 1975).
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
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 sensiters.
Based on the available information, tetradecan-1 -ol does not require
classification for skin sensitisation according to Regulation (EC) No
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