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EC number: 701-162-1
CAS number: -
Study design: The study was performed equivalent to the OECD
Guideline 414 with the deviation that 5 pregnant animals per dose group
were used. The application route was per gavage with water as vehicle.
The applied doses were 0, 8, 40 and 200 mg/kg bw. The observations
parameters were according to the Guideline as well.
Maternal toxicity: Upon clinical observation no effect indicative
of toxicity was found. At 200 mg/kg bw the food consumption and the body
weight gain were slightly reduced. No effect was found for animals of 40
and 8 mg/kg bw.
Reproduction data upon Caesarian section: No difference was found
for control and treated animals upon investigation on number of corpora
lutea, implantation sites and number of live fetuses.
examination: two fetuses of 200 mg/kg bw exhibited abnormalties; one no
lower jaw, small mouth opening and possibly a cleft palate and the other
a cleft palate.
abnormalities: all fetuses of 200 mg/kg bw had small spleen and
incomplete fusion of nasal septum to palate; small spleen was found down
to dose level of 8 mg/kg bw.
abnormalities: abnormalities were found in all fetuses of 200 mg/kg bw,
comprising thin skull zygomatic jugal arch, abnormal curvature of
pectoral girdle clavicle, absent humerus deltoid tuberosity in forelimb,
short mid region of rib cage, abnormal curvature of hyoid body and
abnormal spacing of zygomatic arch structures; increased number of
supernumerary ribs was found at 200 and 40 mg/kg bw.
Tab: Incidence of some fetal toxicity found down to mid/low doses
a) Small spleen in intrauterine exposed fetuses
8 mg/kg bw
40 mg/kg bw
200 mg/kg bw
Spleen small or small severe (total)
Small (ca. 75% of expected size)
Small severe (ca. 50% of expected size)
b) Supernumerary ribs, rudimentary in intrauterine exposed fetuses
Conclusion: Clear toxic effects were found for fetuses at doses
that were not associated with an apparent maternal toxicity.
The developmental toxicity of the registration substance was
assessed based on data on the read-across substances,
(Pentapropylensuccinimido)-hexanoic acid, sodium and triethanolamine
(Pentapropylensuccinimido)-hexanoic acid, sodium and
triethanolamine salts was investigated for its developmental toxicity
equivalent to the OECD Guideline 414 with the deviation that 5 pregnant
animals per dose group were used. The application route was per gavage
with water as vehicle. The applied doses were 0, 8, 40 and 200 mg/kg bw.
The observations parameters were according to the Guideline as well.
No significant clinical effect was found for all treated dams. At
200 mg/kg bw the food consumption and the body weight gain were slightly
reduced. No effect was found for animals of 40 and 8 mg/kg bw.
With respective to the reproduction performance of the treated
animals, the investigated parameters such as number of corpora lutea,
implantation sites and number of live fetuses were comparable to those
of control animals.
Upon examination of fetuses, increased frequency of a small spleen
was noted down to the dose level of 8 mg/kg bw/day. Increased number of
supernumerary ribs (rudimentary) was noted at the dose levels of 200 and
40 mg/kg bw/day. In addition, changes in the size or shape of the
nasopharyns, nasal septum incompletely fused to the palate as well as
several abnormalitiers and variations in skeleton were noted at the dose
level of 200 mg/kg bw/day.
Based on the fetotoxicity found down to dose of 8 mg/kg bw, the
LOAEL of 8 mg/kg bw was established.
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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