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EC number: 629-693-3
CAS number: 740817-83-8
In a guideline 28-day study, an oral NOAEL of 300 mg/kg bw/day was determined for Safol 23 (Sasol 1999) but the effects seen in this study are not ascribed to a dose response effect but rather are associated with the method of dosing, and therefore are not suitable as a basis for DNEL. In studies on related materials, oral NOAELS were 2000 mg/kg bw/day for Dodecanol (Hansen 1992a) and 1440 mg/kg bw/day for Alcohols C7-11 branched and linear (Hellwig & Jackh 1997). A read-across from a reliable 13-week dietary study in rats using Hexanol reported a NOAEL of 1127 mg/kg bw/day and no adverse effects were noted at any of the dose levels administered during the study (Scientific Associates Inc. 1966).
In some cases the CAS and chemical
identity stated refer to SDA nomenclature for this substance. In REACH
substance identification it is necessary to be more specific as to the
chain lengths present. Full details may be found in the CSR.
The key study was a 28-day oral toxicity
assay, conducted to OECD guideline 407 and to GLP, in which the test
material (Safol 23) was diluted in corn oil and administered to male and
female rats by oral gavage. An NOAEL of 300 mg/kg bw/day was identified
from this study, based on adverse effects at 1000 mg/kg bw/day (clinical
signs, body weight, food consumption, food efficiency, haematology,
clinical chemistry) (Sasol 1999).
The effects seen in this study are not ascribed to a dose response
effect but rather are associated with the method of dosing, and
therefore are not suitable as a basis for DNEL.
The Category hypothesis is that the long
chain linear aliphatic alcohol family has at its centre an homologous
series of increasing carbon chain length, which is associated with a
consistency and predictability in the property data across the group,
for the physicochemical, environmental and toxicological property data
sets. In view of the structural and chemical similarities, it is
considered that the results from a number of reliable repeated dose
toxicity studies on single- or multiple-constituent alcohols with
appropriate chain lengths can be read across to alcohols C12-13 branched
In a combined repeat dose and
reproductive/developmental toxicity screening test performed to draft
OECD guideline 422 and to GLP, an oral NOAEL of 2000 mg/kg bw/day (the
highest dose tested) was established in rats for Dodecanol (Hansen
1992a). No maternal toxicity was seen in rats after oral gavage dosing
with Alcohols C7-11 branched and linear at up to 1440 mg/kg bw/day on
days 6 to 15 of gestation and this top dose was therefore the NOAEL
(Hellwig & Jackh 1997). For
Hexanol, oral NOAELs were 1127 and 1243 mg/kg bw/day (the highest doses
tested) in male and female rats respectively in a 90-day repeated dose
toxicity test in which a somewhat limited range of endpoints was
evaluated (Scientific Associates 1966a).
For Hexadecanol, oral NOAELs were 723 and
875 mg/kg bw/day in male and female rats respectively in a 90-day
repeated dose toxicity test in which a somewhat limited range of
endpoints was evaluated, based on adverse effects in males and females
at 1822 and 2064 mg/kg bw/day and above, respectively, including reduced
food consumption in both sexes and also reduced body weight gain and
some organ weight changes in females (Scientific Associates 1966a).
Using a protocol similar to OECD guideline 407, a GLP study, in which
male and female rats were administered Hexadecanol by oral gavage on 5
days/week for 28 days, established an NOAEL of 1000 mg/kg bw/day, the
highest dose tested (Henkel 1985a). In a limited study, conducted prior
to the introduction of GLP, Alcohols C16-18 and C18 unsatd. was
administered to male and female at a single dose level of 840 mg/kg
bw/day by oral gavage and no toxicity was reported (Henkel 1973).
No repeated dose toxicity studies were
available on any of the long chain linear aliphatic alcohol family by
the dermal route.
No reliable guideline repeated dose toxicity
studies were available on any of the long chain linear aliphatic alcohol
family by the inhalation route.
and sub-chronic toxicity studies have shown that long chain alcohols
(LCA) are of low toxicity. Furthermore, combined repeated-dose studies
with developmental endpoints, as well as reproductive and developmental
studies showed no effects at the highest dose tested. Rather than having
separate values for the three endpoints, one endpoint ¿systemic effects¿
has been used instead. Since the NOAELs do not vary greatly across the
category, one key study has been chosen as being representative of the
Based on the available data, Alcohols C12-13
branched and linear would not be classified for specific target organ
toxicity-repeated exposure under Regulation (EC) No. 1272/2008 (CLP)
since no adverse effects occurred at <100 mg/kg bw/day, or for danger of
serious damage to health by prolonged exposure under Directive
67/548/EEC (DSD) since no adverse effects occurred at <50 mg/kg bw/day.
Tests on similar substances included in this category are also
supportive of these results, which do not warrant classification under
DSD or GHS criteria.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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