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EC number: 903-919-3
CAS number: -
According to ECHA factsheet of 15/09/2009 ECHA considers registration
dossiers for substances ≥ 1000 t/y as technically complete even if they
do not contain the results of a screening study for
reproductive/-developmental toxicity if the following condition is met:
The dossier contains either the results of, or a testing proposal for, a
prenatal developmental toxicity study and either the results of, or a
testing proposal for, a 2-generation reproductive toxicity study.
Testing proposals for a prenatal developmental toxicity study and for a
2-generation reproductive toxicity study were created in IUCLID sections
7.8.2 and 7.8.3. Details on the proposal can be found in the attached
document. The study proposals on reproductive toxicity are still under
evaluation by ECHA.
None of the main components of the reaction mass was found to be toxic
for reproduction based on literature data, except for TBA, which
produced skeletal anomalies in a 19 -day reproduction toxicity study
(see table below). Hence, it is possible that a certain degree of
developmental toxicity may also be found for the reaction mass.
Table: Reproduction toxicity data for the main components of the
reaction mass from literature
From analogue, SBA: Rat, 8-week, 2-generation study:
NOAEL (maternal and developmental toxicity): 1771 mg/kg/day
From analogue, SBA: Rat, 20-day, prenatal developmental toxicity study: NOAEL: 3500 ppm (maternal toxicity)
NOAEL: >7000 ppm (developmental toxicity)
Overall the weight of evidence indicates that analogue sBA does not produce teratogenic (developmental) toxic effects in the developing embryo/fetus of laboratory animals. In a 2-generation study on rats, no effects of SBA on fertility were noted.
Rat, 20-day, prenatal developmental toxicity study: NOAEL: 430 ppm (maternal and developmental toxicity)
Rat, 13-week, subchronic toxicity study: NOAEL: 480 ppm (reproductive effects)
DIPE is not a teratogen. No changes in reproductive organ weights and structure or sperm and spermatid number were noted in a subchronic toxicity study.
Rat, 8-week, 2-generation study: NOAEL (maternal and developmental toxicity): 1771 mg/kg/day
Rat, 20-day, prenatal developmental toxicity study:
NOAEL: 3500 ppm (maternal toxicity)
SBA is not a developmental toxicant. There was no evidence of teratogenic events nor was there evidence of selective developmental toxicity. In a 2-generation study on rats, no effects on fertility were noted.
Rat, 4-weeks, 1-generation study:
NOAEL (maternal toxicity) = 1000 mg/kg-bw/day
NOAEL (reproductive/developmental toxicity) = 400 mg/kg-bw/day
Mouse, 22-days, prenatal developmental toxicity study:
NOAEL (maternal toxicity) = 1500 mg/kg-bw/day
LOAEL (developmental toxicity) =1125 mg/kg-bw/day
Mouse, 18-days, prenatal developmental toxicity study:
LOAEL (developmental toxicity) = 1550 mg/kg-bw/day
Rat, 19-day, prenatal developmental toxicity study:
NOAEL (maternal toxicity) = 15.2 mg/L
LOAEL (developmental toxicity) = 6.06 mg/L
A prenatal developmental toxicity study revealed significant increases in the incidence of skeletal anomalies (primarily delayed skeletal ossification) in treated offspring.
In a one-generation study, no effects on reproductive organs, mating success, fertility, or sperm quality were observed; however a slight increase in the length of gestation (significance not specified) was observed at the two highest doses. Furthermore, an increase in estrous cycle length was observed in female mice in a 13-week repeated-dose study.
(1) HIGH PRODUCTION
VOLUME (HPV) CHEMICAL CHALLENGE PROGRAM TEST PLAN For sec-Butyl Ether
CAS NO. 6863-58-7, Prepared by: ExxonMobil Chemical Company, November
Chemical Company Shell Chemical LP For: American Chemistry Council,
lsopropanol Panel, Diisopropyl Ether HPV Task Group December
(3) OECD SIDS Dossier
for Butan-2 -ol, CAS No.78 -92 -2, ExxonMobil Biomedical Sciences
(4) Robust Summaries
for t-Butanol, CAS Number 75 -65 -O USEPA HPV Challenge Program
See discussion on effects on fertility.
Based on the available data on the consitutents, the reaction mass is
not classified as toxic to reproduction. This will be verified with the
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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