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EC number: 500-003-1
CAS number: 9003-13-8
An OECD 422 study in rats (via the oral
route) is available for TPnB-highers. No fertility effects were observed
in this study. A NOAEL for fertility effects of 500 mg/kg bw/day has
been established. No 2-generation reprotox study is available for
TPnB-highers. However, the structurally related propylene glycol methyl
ether (PGME) has undergone this type of testing. PGME is closely related
in molecular structure and physicochemical properties and thus, the
potential for toxicological effects. The category of glycol ethers are
liquids with comparable physical chemical properties. Increasing boiling
point and vapor pressure are consistent with increasing molecular
weight. No major differences in the toxicological profile have been
observed between propylene glycol ethers e.g. mono-, di- and
tri-propylene glycol methyl ethers and mono-, di- and tri-propylene
glycol n-butyl ethers. In a 2-generation reproductive toxicity study
with PGME via the inhalation route no direct reproductive toxicity was
observed at doses up to 3000 ppm. Ovarian weights were decreased (with
accompanying atrophy) at 3000 ppm but not 1000 ppm, considered secondary
to severe maternal weight loss of 21% at 3000 ppm. PGME did not cause
any reduction in sperm counts or mobility.
An OECD 422 study in rats is available for TPnB-highers. In addition, available data on structural analogues propylene glycol butyl ether (PnB), dipropylene glycol butyl ether (DPnB) and tripropylene glycol methyl ether (TPGME) is used for read-across.For PnB and DPnB dermal developmental toxicity study in rats according to OECD guideline 414 are available. For TPGME an OECD 414 inhalation developmental toxicity study in rats is available.
An OECD 422 study in rats (via the oral
route) is available for TPnB-highers. No developmental toxicity effects
were observed in this study. A NOAEL for developmental effects of 500
mg/kg bw/day has been established. No developmental toxicity study
according to OECD guideline 414 is available for TPnB-highers. However,
the structurally related substances propylene glycol butyl ether (PGBE),
dipropylene glycol n-butyl ether (DPGBE) and tripropylene glycol methyl
ether (TPGME) have undergone this type of testing as well as a number of
other propylene glycol ethers. PGBE, DPGBE, TPGME and TPnB-highers are
closely related in molecular structure and physicochemical properties
and thus, the potential for toxicological effects. They are liquids with
similar physical chemical properties. Increasing boiling point and vapor
pressure are consistent with increasing molecular weight. No major
differences in the toxicological profile have been observed between
other glycol ethers families (e.g. mono-, di- and tri-propylene glycol
methyl ethers). The results of propylene glycol ethers were consistently
negative in developmental toxicity studies. PGBE, DPGBE and TPGME are
not maternally toxic, embryo- or fetotoxic, or teratogenic in rats or
rabbits. Hence, the developmental toxicity studies on PGBE, DPGBE and
TPGME are used to fulfill the developmental toxicity requirement for
TPnB-highers by read-across.
Since TPnB-highers has undergone a repeated
dose toxicity and reprotox testing in an OECD 422 study, conclusions can
be drawn regarding damage to reproductive organs. Results from the study
indicate that TPnB-highers did not cause toxicity to the testes.
Specifically, no reduction in testicular weight, no damage to the sperm
or sperm-producing cells, and no damage to the epididymis or
seminiferous tubules were reported. Likewise, no damage to female
reproductive organs was found. In addition, read-across data from
another P-series glycol ether (2-generation reprotox study on PGME and
several developmental toxicity studies, e.g. with PGBE, DPGBE and TPGME)
are available to address these endpoints. No treatment-related effects
on reproductive parameters or developmental effects were observed with
PGME. Therefore, TPnB-highers should not be classified for reproductive
toxicity or developmental effects.
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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