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EC number: 906-083-8
CAS number: -
The present data on carcinogenicity are not sufficient to fulfill the
criteria laid down in 67/548/EEC and regulation (EU) 1272/2008 and
therefore, a non-classification is warranted.
No data on carcinogenicity are available for the reaction mass. To
evaluate the carcinogenic potential of one of the main components, i.e.
geranyl acetate, a 2 year study with food grade geranyl acetate
performed by NTP (1987) was taken into account for assessment.
In this study, 50 F344 rats per sex and dose were gavaged with
doses of 1000 and 2000 mg/kg bw/day of a solution of food-grade geranyl
acetate containing 71% geranyl acetate (CAS 105-87-3) and 29%
citronellyl acetate (CAS 150-84-5). Administration was 5 times a week
for 103 weeks. For analysis, all animals were observed twice daily for
signs of morbidity or mortality and clinical signs and body weights were
recorded every week for the first 12 weeks and monthly thereafter. Major
tissues or organs were examined for grossly visible lesions. A detailed
histopathological examination was performed.
Increased mortality was observed in the males group treated with
the highest test dose of 2000 mg/kg bw/d, indicating a cumulative
toxicity of the test substance. The body weights were reduced after 40
weeks and an evident depression in bodyweight gain was observed in males
and females at 2000 mg/kg bw/d. No compound-related clinical signs were
observed an any dose level.
Increased incidence of retinopathy or cataracts has been observed
in high dose males and low dose females. These findings were stated not
to be related to test substance administration but to the proximity of
the rats to a source of fluorescent light.
Increased incidence of nephropathy was found in high dose animals.
However, an inconsistent dose response relationship, i.e. lower
incidences in the low dose group compared to control animals, has been
observed, questioning a clear relationship to test substance
A negative trend in the incidences of mammary gland fibroadenomas,
pituitary adenomas and pancreas islet cell adenoma/carcinoma was
observed in test substance treated animals. Neoplastic lesions of
interest were as follows:
Two males of the low dose group displayed kidney tubular cells
adenoma which has not been found in high dose and control male animals.
Furthermore increased incidences of skin squamous cell
papilloma/carcinoma have been observed in the low dose males, which were
lower in high dose and control animals. The authors stated that the
observed increased mortality in the high dose group lowered the
sensitivity of the study for detecting neoplastic substance-related
changes, and a relationship to test substance administration cannot be
However, the lesions squamous cell papillomas/carcinomas and
kidney tubular cell adenomas, could not be clearly associated with the
administration of the test substance and under the conditions of the
present study, the test substances geranyl acetate/citronellyl acetate
were not found to be carcinogenic.
In the supportive study from the same authors, 50 male and female
B6C3F1 mice were treated with food-grade geranyl acetate (71% geranyl
acetate and 29% citronellyl acetate) orally via gavage with doses of 500
and 1000 mg/kg bw/day for 102 weeks NTP (1987). The respective study had
limitations in study execution.
All mice of the high dose group accidentally died by week 91
because of a dosage error (2800 mg/kg bw administrated during 3 days
instead of 1000 mg/kg bw). In both the low dose and the control group,
an infection of the genital tract resulted in the death of 8 and 14
females, respectively. Furthermore, mortality due to gavage errors
occurred in 3 males of control, 3/3 males/females of low dose and 2
females of the high dose group and mortality by to drowning due to
flooding was found in 3 males of the control group. Evident decreases in
body weights and body weight gains was found in high dose animals (1000
mg/kg bw/d). No compound-related clinical signs were observed.
Cytoplasmic vacuolisation, i.e. lipidosis due to the presence of
lipid droplets, was observed in liver (mid/ high dose animals) and
kidneys (mid/high dose females and high dose males). Geranyl acetate
induced lipidosis seems to be species specific since these findings were
not observed in rats.
No evidence of test substance related carcinogenicity was
observed. A negative trend in the incidences of malignant lymphomas and
follicular cell adenomas in the thyroid was observed in test substance
treated animals. However, according to the authors, the death of all
high dose mice as well as of numerous females of the low dose group
lowered the sensitivity of the study for detecting neoplastic
Overall, no evidence of carcinogenic effects were observed, so
that under the conditions of the present study, the test substances
geranyl acetate / citronellyl acetate were not found to be carcinogenic.
Therefore a carcinogenic potential of the discussed reaction mass is not
to be expected.
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