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EC number: 931-299-4
CAS number: 68390-94-3
Testing proposed: Extended One-Generation Reproductive Toxicity Study
(EOGRTS, OECD 443), basic test design (cohorts 1A and 1B without
extension to include a F2 generation), rat, oral administration
A testing proposal for an Extended One-Generation Reproductive Toxicity
Study (EOGRTS, basic test design (cohorts 1A and 1B without extension to
include a F2 generation), rat, oral administration), according to OECD
guideline 443 is provided to fulfil the standard information requirement
of Annex X, Item 8.7.3.,of Regulation (EC) No. 1907/2006. As soon as the
final results of the study are available, the technical dossier will be
Developmental toxicity / teratogenicity (OECD 414, rat): NOAEL(maternal
toxicity) ≥ 1000 mg/kg bw/day; NOAEL(development) ≥ 1000 mg/kg bw/day
Testing proposed: Prenatal Developmental Toxicity Study (PNDTS, OECD
414), rabbit, oral administration
Neither clinical signs nor signs of reaction to treatment were noted in
treated females. No significant differences were noted in body weight,
food consumption, gravid uterus weight, litter data and macroscopic
observation of treated females when compared to controls. No
treatment-related changes were seen at the external, visceral and
skeletal examination of foetuses from all groups. On the basis of the
results obtained in this study, the dosage of 1000 mg/kg bw/day is
considered as the NOAEL.
The results indicate that Licowax C is not maternally toxic or
embryotoxic at the tested dose levels and the high dosage of 1000 mg/kg
bw/day could be used for a subsequent main study.
There is data available from a prenatal developmental toxicity study
(Liberati, 2009), which was chosen as the key study, and the
corresponding preliminary test which served as a range finder (RTC,
In the key study doses of 100, 300 and 1000 mg/kg bw/day, which had been
analytically confirmed, were administered by oral gavage. No maternal
toxic effects were observed up to the highest dose of 1000 mg/kg bw/day,
there were no mortality or clinical signs observed. Food consumption and
body weight development were not affected by treatment with the test
substance, either. The number of dams with live fetuses was comparable
among all dose groups. Litter data and sex ratio were not affected by
the treatment, and no visceral or skeletal abnormalities were noted
within the foetuses which could be attributed to the test substance.
This view was supported by the corresponding range-finder study (RTC,
2008), which was conducted with a reduced animal number, and no analysis
of the administered dose. No mortality occurred during the study,
either. All females were found pregnant at necropsy. No signs of
toxicological significance were noted in any treated female. No signs of
reaction to treatment were recorded at the daily post-dose observations
performed 1 h after administration. Soft faeces on the cage tray were
occasionally observed in the high dose group. Body weight and body
weight gain in treated females were comparable to controls through the
study. No differences were noted in litter data parameters between
control and treated females. No relevant findings were reported at the
macroscopic observation of females. Staining on different areas of body
surface noted in some animals was not considered treatment-related. In
this range-finder study the foetuses were only examined externally, and
no abnormalities were detected.
In order to investigate the developmental toxicity in a second
(non-rodent) species, a testing proposal for a Prenatal Developmental
Toxicity Study (PNDTS, OECD 414), rabbit, oral administration, is
provided to fulfil the standard information requirement of Annex X, Item
8.7.2., of Regulation (EC) No.. 1907/2006. As soon as the final results
of the study are available, the technical dossier will be updated.
The available data on developmental toxicity of the test substance
in the rat do not meet the criteria for classification according to
Regulation (EC) No. 1272/2008. However, as no studies investigating the
reproductive toxicity and the developmental toxicity in a second
(non-rodent) species are available, no final hazard conclusion, incl.
classification, can be made. Since there is no indication of any adverse
systemic toxic effect in any of the available acute and subchronic
studies, the registered substance is not classified for reproductive
toxicity based on 'data lacking'. As soon as the
reproductive and developmental toxicity studies proposed are finalised,
the hazard assessment and the 'justification for classification or
non-classification' will be updated.
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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