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EC number: 231-415-7
CAS number: 7540-51-4
The substance is a liquid with a molecular weight of156.27g/mol.
The substance has a relatively low vapour pressure and is
non-volatile and therefore inhalation is not considered to be a
significant route of exposure.
The substance has a moderate log octanol/water partition
coefficient (log Pow 3.7) and is water soluble (325.6 mg/L).
The substance caused mortality in an acute oral toxicity study at
high doses (3200 mg/kg bw and above). Mortality in an acute dermal
toxicity study was observed at 2500 mg/kg and above, plus moderate signs
Oral repeated dose studies, showed some mortality and some
possible evidence of absorption.
The substance is a skin irritant and a skin sensitiser.
The substance was non-mutagenic in in-vitro and in-vivo
genotoxicity studies, in either the presence or absence of an auxiliary
The test item is a relatively low molecular weight liquid that is
readily soluble in water and has a moderate log Octanol: Water partition
coefficient (log Pow 3.7). This suggests that the test item has the
potential to cross biological membranes, via diffusion, such as those of
the gastro-intestinal tract following oral ingestion. The results of the
acute oral toxicity study on a source substance showed mortality only at
very high concentrations (≥3200 mg/kg bodyweight).
Repeated dose toxicity studies found that oral administration of a
source substance linalool/citronellol mixture in a feeding study in rats
at 51 and 56 mg/kg bw/day caused reduced food intake and body weight
gain in males, however, the authors attributed this effect to be caused
by the palatability of the given mixture and considered these effects to
be biologically insignificant. In a limited urine analysis, in
haematology, in gross examinations and in liver and kidney weights, no
test substance related effects were observed. The NOEL was determined as
51 and 56 mg/kg bw/d (the highest doses tested) citronellol for males
and female, respectively.
Another source substance of geraniol (3,7-dimethyl-2,6-octadienol) and
the isomer (3,7-dimethyl-1,6-octadienol) was fed to five male and five
female individually housed Osborne-Mendel rats Concentrations of 1000
ppm (= ca. 55 mg/kg bw/day) were administered for 189-169 days and a
concentration of 10000 ppm (= ca. 550 mg/kg bw/day) was given for 112
days. No clinical signs, no effects on body weight as well as no
histopathological changes were observed, and the NOEL could be estimated
as 10000 ppm. Thus the NOAEL would be > 550 mg/kg bw/day.
Repeated dose toxicity was also analysed in a 13 week oral toxicity
study at doses of 250, 500, 1000, 2000 and 4000 mg/kg bw/d of food-grade
geranyl acetate (71% geranyl acetate (CAS 105-87-3) and 29% citronellyl
acetate (CAS 150-84-5). 1/10 female and 2/10 male of the 4000 mg/kg bw/d
group died. Besides mortality, the observed substance related toxic
effect was a depressed mean body weight of the animals of the 4000 mg/kg
bw/d group compared to control (19% for the males, 8% for the females).
Three males showed reddened mucosa of the stomach, however no test
substance related histopathological changes were observed. Thus, a NOAEL
of 2000 mg/kg bw/d of food-grade geranyl acetate has been set,
corresponding to 580 mg/kg bw/d citronellyl acetate. In the same study,
also, ten male and female B6C3F1 mice per dose were gavaged at doses of
125, 250, 500, 1000, 2000 mg/kg bw food-grade geranyl acetate for the 13
week study. Seven males and nine females of the 2000 mg/kg bw group
died. No other clinical signs of toxicity were noted during the study.
The males of the 2000 mg/kg bw group exhibit a delay in body weight
gain. Liver, kidney and myocardium of males and females of the 2000
mg/kg bw group displayed cytoplasmic vacuolization with lipid inclusions
indicative of fatty degeneration. Furthermore, stomach lesions including
inflammation and edema were reported in this group. Thus, the NOAEL was
set at 1000 mg/kg bw/d food-grade geranyl acetate corresponding to 290
mg/kg bw/d citronellyl acetate.
In an oral OECD 421 study rats were treated at concentrations 100, 300
and 1000 mg/kg bw/day Nerol/Geraniol. Clinical observations indicated
distinct toxicity in the exposed parental animals of the highdose group
(1000 mg/kg bw/d) but not in the animals of the mid- and low-dose group.
A reduction of food consumption (up to 10% in males and females during
treatment weeks 0-1 as well as females (-34%) during lactation), and
decreased body weight in males (up to -5%) had been determined during
treatment weeks 2-4. The body weight change in males was reduced from
week 0 to 5 (-28% on average in this time period). In females a
significant body weight change was observed during lactation leading to
a body weight loss (-3%). Consequently, the body weight was decreased in
males during treatment weeks 2-5 (-7%) and in females of week 6 (-9%).
Therefore the NOAEL for systemic toxicity in adults was 300 mg/kg
bw/day. The test compound did not adversely affect fertility of the F0
generation parental animals at all dose levels as there were no changes
of male/female mating and fertility indices, time until successful
copulation, duration of pregnancy and mean number of implantations.
Therefore, the NOAEL for fertility was 1000 mg/kg bw/day.
There is an alert for a dose-dependent adverse effect of the test
substance on pre-/postnatal development of the F1 offspring at mid and
high-dose level (300 and 1000 mg/kg bw/d) indicated by a decrease in
viability and body weight. The NOAEL for the F1 generation was therefore
100 mg/kg bw day. These effectsare
likely to be secondary to maternal toxicity as evidenced by clinical
observations, empty stomachs in pups and significantly reduced feed
consumption and body weights during the lactation period. The
developmental NOAEL of 100 mg/kg bw/day is also conservative given that
the overall viability of 91% at the mid-dose is not significant compared
to the 97% viability reported in the low-dose.
These results would suggest that there is some potential absorption of
the test item following oral administration, but not significant
Some passage across the dermal barrier may be possible as the substance
is a liquid and the Log P value and water solubility favours moderate to
high dermal absorption. Skin absorption was predicted to be ≤ 80% by a
Skin Absorption Model (SAM), based on a calculated Jmax value. The
substance is a skin irritant, and therefore damage to the skin surface
may enhance penetration. The substance is also a skin sensitiser,
suggesting that some uptake of the substances occurs. An acute dermal
toxicity study showed clinical signs of systemic toxicity at doses from
1250 mg/kg bodyweight and above (where 2 animals were reported as weak
and unable to stand at 1250 mg/kg bw, ataxia in 4 animals at 2500 mg/kg
bw and ataxia and pupillary dilation at 5000 mg/kg bw). A reproductive
toxicity screening study via the dermal route on the source substance
Geraniol in the rat at doses 150, 300 and 450 mg/kg bw/d found no
evidence of systemic toxicity. These results would suggest that there is
some potential absorption of the test item following dermal
As the material does not exist as particulates and the material has low
volatility (vapour pressure < 0.5kPa), exposure via the inhalation route
is limited. The Log P value is favourable for absorption directly across
the respiratory tract epithelium by passive diffusion. The results
observed in oral toxicity studies on source substances that indicates
the potential for absorption following ingestion, also indicates that
the substance may also be absorbed if it is inhaled.
As the test item is of low molecular
weight and is water soluble, it can be assumed that any absorbed test
item can be readily distributed in the water fraction of circulatory
fluids. This may be supported by effects observed in oral repeated dose
toxicity studies. As the substance evoked a skin sensitization response,
this would suggest the material may bind to circulatory proteins. The
limited fat solubility suggests the material is unlikely to accumulate
in body fat.
The results of the repeated dose toxicity studies and reproductive
toxicity screening studies show no evidence of enhanced hepatic
metabolism and the fact that the material is already freely water
soluble suggests that metabolism may not be required to enhance
excretion. Genotoxicity studiesin vitroshow that the genotoxic
potential of the test item is neither enhanced nor diminished in the
presence of S9 microsomal metabolising system.
Low molecular weight test items that are water soluble are most likely
to be excreted via the kidney although the repeat dose studies give no
indication of route of excretion. Following oral ingestion, any test
item that is not absorbed is likely to be excreted in the faeces.
The test item is a low molecular weight liquid that is water soluble.
Any oral ingestion of the test item may lead to absorption and systemic
distribution, there may also be some limited adsorption via the dermal
and inhalation routes. The test item is unlikely to be metabolised and
excretion is most likely to be via the kidney.
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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