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EC number: 282-780-4
CAS number: 84418-68-8
No repeated dose toxicity study with
zinc neodecanoate basic is available, thus the repeated dose toxicity
will be addressed with existing data on the individual assessment
entities zinc and neodecanoate.
In relevant and reliable repeated dose
toxicity studies as well as supporting studies for both assessment
entities of zinc neodecanoate basic, there were no toxicological
findings reported that would justify a classification for specific
target organ toxicity - repeated exposure, oral.
From studies in which humans were
supplemented with zinc (as zinc gluconate) it was concluded that women
are more sensitive to the effects of high zinc intake and that a dose of
50 mg Zn/day is the human NOAEL. This corresponds to a daily exposure of
0.83 mg Zn/kg bw. At the LOAEL of 150 mg Zn/day, clinical signs and
indications for disturbance of copper homeostasis have been observed.
Studies conducted on animals are not discussed here, since information
on human experience are considered of higher relevance for hazard
assessment purposes and should take precedence over animal studies. For
further information on the toxicity of zinc, please refer to the
relevant sections in the IUCLID and CSR.
Repeated dose toxicity, oral:
Seven male and seven female rats were
exposed to 0; 10; 30; 100, or 300 mg/kg/day propanoic acid,
2,2-dimethyl- (CAS# 75-98-9) by oral gavage for 28 consecutive days
(Shell Research Ltd., 1990). No treatment related changes were observed
in body weight, food intake, haematology, or histopathology. The only
clinical signs seen in this study were a shaking of heads, sneezing,
dark nasal discharge, immediately after dosing 100 and 300
mg/kg/day. This behaviour could result from a mild irritant effect of
the volatile acidic test compound. Slight increase of alkaline
phosphatise, cholesterol and bilirubin levels at the 100 and 300
mg/kg/day dose levels, and slight increase of alkaline phosphatise and
cholesterol levels in the plasma of females at the 30 mg/kg/day dose
level. Increase in kidney and liver weight was observed in the 300
mg/kg/day group. None of these changes correlated with histopathological
effects. These findings were considered adaptive changes and not
indicative of a treatment-related adverse effect. The no observed
adverse effect level (NOAEL) in this study was 300 mg/kg.
Five male and five female rats were
exposed to 0; 10; 55; or 300 mg/kg/day fatty acids, C9-C13 neo (CAS#
68938-07-8) by oral gavage for 28 consecutive days (Shell Internationale
Petroleum Maatschappij, 1994). There were no mortalities. Increased
salivation was observed after dosing in rats receiving 300 mg/kg. No
treatment related changes were observed in body weight, food
consumption, haematology, or clinical chemistry. In males receiving 300
mg/kg, kidney weight increased and necropsy revealed an abnormal
appearance of the kidney. A dose-related hyaline droplet was noted in
males at all treatment levels. The findings in the kidney of the treated
males are species and sex specific and not considered relevant to
humans. The NOAEL in this study was 300 mg/kg.
In a repeated-dose dermal study,
neodecanoic acid was applied repeatedly (once daily for 10 applications
with a rest period on days 5 and 6) to the skin of rabbits at doses of
0.5 or 2.5 ml/kg (400 or 2280 mg/kg/day). All animals survived the
exposure. Wheezing was noted in one animal at the 0.5 ml dose level.
Animals at the lower dose level generally showed an overall body weight
gain while those at the high level showed terminal weight losses. The
low level animals generally showed slight erythema and moderate atonia
and desquamation following the first or fourth application and during
the remainder of the study. At the high level, moderate erythema and
moderate or marked atonia and desquamation were present in all animals.
In addition, slight edema was present following the fifth application
and slight fissures or cracks were observed in several animals following
the last seven applications. The exposed skin also became
hypersensitive to the touch. There were no indications of systemic
toxicity attributed to exposure.
A repeated dose dermal toxicity study
was conducted for propanoic acid, 2,2-dimethyl- (CAS# 75-98-9) in male
rabbits (Hazelton Laboratories Inc., 1964). Test material in isopropyl
alcohol solution was repeatedly applied to the shaved intact skin of
albino rabbits 5 days/week for two weeks (for a total of 10
applications) at doses of 30 or 300 mg/kg/day. Slight to moderate
irritation at the low dose and moderate to marked irritation at the high
dose was observed. Slight or moderate erythema, atonia, and desquamation
were seen at the low dose. At the high dose, skin irritation consisted
of moderate erythema, slight to marked edema, moderate or marked atonia
and desquamation. Some dermal necrosis at the site of application was
seen in three rabbits and persisted throughout the study. Control
animals that received only the solvent (isopropyl alcohol) showed slight
irritation. There were no signs of systemic toxicity attributable to
dermal absorption of propanoic acid, 2,2-dimethyl-. The NOAEL for
systemic toxicity in this study was 300 mg/kg.
Carboxylic acid, C6-8 neo (CAS#
95823-36-2) was applied at 55.4 mg/kg and 553.7 mg/kg to the shaved
intact skin of rabbits for 10 applications (Hazleton Laboratories, Inc.,
1964). No treatment related effects were observed on behaviour of
clinical signs during the in-life phase of the study. Gross pathology of
the animals in all dose groups did not reveal any
abnormalities. Repeated application of carboxylic acid C6-8 neo did
produce marked skin irritation with some dermal necrosis at the site of
application in the high dose group. Since no systemic effects were
observed in this study, the NOAEL for systemic effects following
subchronic dermal application of carboxylic acid, C6-8 neo was 553.7
Members of the Neo acid C5 to C28
Category have a low order of toxicity under conditions of repeat
exposure by oral and dermal routes. In addition, they display a
consistent degree of subchronic toxicity by either oral or dermal route
of exposure. No classification for repeated dose toxicity is indicated
according to the classification, labelling, and packaging (CLP)
regulation (EC) No 1272/2008.
Zinc neodecanoate basic
Since no repeated dose toxicity study
is available specifically for zinc neodecanoate basic, information on
the individual assessment entities zinc and neodecanoate will be used
for the hazard assessment and when applicable for the risk
characterisation of zinc neodecanoate basic. For the purpose of hazard
assessment of zinc neodecanoate basic, the point of departure for the
most sensitive endpoint of each assessment entity will be used for the
DNEL derivation. In case of neodecanoic acid in zinc neodecanoate basic,
the NOAEL of 75 mg/kg bw/day for the reproductive toxicity will be used.
For zinc the NOAEL of 0.83 mg/kg bw/day (human data) will be used.
In relevant and reliable repeated dose
toxicity studies as well as human data for both entities formed upon
dissolution of zinc neodecanoate basic, namely zinc and neodecanoate,
there were no toxicological findings reported that would justify a
classification for specific target organ toxicity with repeated
exposure. Hence, no classification for zinc neodecanoate as STOT-RE,oral
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