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EC number: 939-707-2
CAS number: -
Appearance, behavior and mortality:
Appearance, behavior and mortality of the
dams were unaffected up to and including the dose of 360 mg/kg b.w.
Gross pathological findings in dams:
No treatment related findings were evident
at necropsy up to and including the dose of 360 mg/kg b.w.
General Reproduction data:
The number of corpora lutea, preimplantation
losses and implantations was comparable in all experimental groups, with
exception of the significantly lower preimplantation losses in the 360
mg/kg group (details in Table 3).
The gestation rate was unaffected by the
treatment with doses up to and including 360 mg/kg.
Weight and appearance of placentas:
The placental weight was statistically
significantly decreased at the dose of 360 mg/kg when calculated on
litter basis and from 60 mg/kg and above when calculated in individual
basis.Since the toxicologically more relevant calculation on litter
basis was not affected at the dose of 60 mg/kg and as the values even of
the 360 mg/kg group lay within the range of historical control data, the
statistical significance at 60 mg/kg is not regarded as toxicologically
relevant and even the values obtained at the dose of 360 mg/kg as
equivoqual. Nevertheless, together with the increase number of placentas
with necrotic placental borders at 360 mg/kg, this dose is considered to
be the effect level for placental weight and appearance (details in
Resorption rate, number of fetuses:
The resorption rate and the mean number of
fetuses were not affected by the treatment up to and including the dose
of 360 mg/kg.
Sex and fetuses:
The number of male and female fetuses did
not diffe from those in the controls to any extent at levels up to and
including 360 mg/kg.
The fetal weight was unaffected by the
treatment up to and including 360 mg/kg.
Skeletal system deviations (variations,
At the highest dose of 360 mg/kg, slightly
reduced ossification of the parietal and interparietal bones and the 7th
cervical vertebra were observed as well as an increase in the incidence
of fetuses with wavy ribs. These findings are considered to be treatment
Malformations (details in Table 5):
Neither the type nor the incidence of
malformations were affected by treatment with doses up to and including
The number of abnormal fetuses at 360 mg/kg
was comparable to the control group. All findings in the control and the
360 mg/kg were also observed in previous controls. Nevertheless, there
was a slight difference concerning the distribution of these findings.
Microphthalmia mainly observed in the control group of this study
occured in comparable incidences in previous controls, while the
incidence of vertebral and multiple malformations mainly obtained in the
360 mg/kg group was rather low in previous controls. Therefore a
treatment related effect on the incidence of the verteral and multiple
malformations cannot be excluded. However, incresed incidences of
spontaneoulsy occuring malformations are not regarded as indication of a
specific teratogenic potential.
The remaing individual fetal findings
(deviations) observed at visceral examinations revealed no evidence of
tes substance-related effects in any of the dose troups.
27 inseminated Wistar rats each were treated daily orally by gavage with
Reaction product of naphthalene, butanol, sulfonated and neutralized by
caustic soda formulated in demineralized water from day 6 to day 15 p.c.
in doses of 0, 10, 60, or 360 mg/kg body weight, respectively. The
fetuses were delivered by cesarian section on the 20th day of gestation.
Investigations were performed to determine the general tolerance of the
test substance by the dams, as well as its effect on intrauterine
behavior and appearance of the dams were not affected by the treatment
up to and including 360 mg/kg. The body weight gain in the 60 and 360
mg/kg group dams and the feed intake in the 360 mg/kg group (60 mg/kg
marginally) were reduced during the treatment period. Decreased water
consumption and reduced feces excretion were observed in some dams of
the 360 mg/kg group. There were no test substance-related findings at
necropsy in any of the experimental groups.
respect to intrauterine development, the gestation rate, the resorption
rate and accordingly the number of fetuses, and the fetal sex as well as
fetal weight were unaffected by the treatment up to and incuding 360
In the 360
mg/kg group increased numbers of placentas with necrotic border and
slightly reduced placental weights were observed.
visceral and skeletal examination of the fetuses revealed no treatment
related effects on intrauterine development up to and including the dose
of 60 mg/kg. At
the dose of 360 mg/kg b.w. increased incidences of vertebral and
multiple malformations that may occur spontaneously were evident, while
the overall incidence of malformations was comparable between control
and 360 mg/kg group. A treatment related effect for this slightly
different distribution cannot be excluded.
primary developmental toxicity was not evident, since all embryotoxic
findings observed at the dose of 360 mg/kg appeared in a maternally
toxic dose range.
Observed Adverse Effect Levels (NOAEL) were thus:
toxicity : 10 mg/kg b.w./day
toxicity : 60 mg/kg b.w./day
in the absence of evident direct embryotoxic effect, the registered
substance is not classified for reprotoxicity according to the
classification criteria of the Regulation (EC) 1272/2008 (CLP) and of
the Directive 67/548/EEC.
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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