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EC number: 252-104-2
CAS number: 34590-94-8
Several non-GLP studies in rabbits equivalent or similar to OECD guidelines 404 and 405 are available for dipropylene glycol methyl ether. These studies are supported by a human volunteer study for eye irritation and a 90-day dermal study in rabbits.
10 informed male volunteers of age range 18
-26 yr, were used in the study in order to obtain effects of controlled
applications of DPGME solutions to the human eye. A droplet, 0.04 ml in
volume, of 20% (v/v) aqueous DPGME was applied to the left eye using a
micrometer syringe equipped with a soft polythene delivery tube.
Measurements were made a few minutes before applying DPGME to the eye, and
at 2-4, 30 and 60 min after contaminating the eye. Application of a 0.04 ml of a 20% aqueous solution to human eyes produced mild transient sensory irritation, hyperemia of conjunctival
vessels and a small increase in intraocular pressure. All effects disappeared within 2 hr.
The test material was classified as not irritating to the eye.
All irritation studies available for
dipropylene glycol methyl ether were conducted prior to GLP and OECD
guidelines. However, the studies are well documented and are considered
to be reliable. Several independent studies are available for each route
of exposure reporting consistent results.
No irritation was observed in rabbits and
humans in any study conducted with dipropylene glycol methyl ether.
Skin - There are two key studies available - BASF
(1979) study in rabbits and Dow (1951) study in humans. In the rabbit study,
the mean erythema and edema scores were 0 for all animals across 24, 48 hours
and 5 days. In the human study no signs of irritation were noted in the 100
male and 100 female human subjects.
Eye - In the key study - Ballantyne (1984) study
in humans, application of 0.04 ml of a 20% aqueous solution to eyes resulted
in mild transient sensory irritation, hyperemia of conjunctival vessels and
a small increase in intraocular pressure and all effects disappeared within
2 hours. In the supporting studies in rabbits, transient and mild irritation
was observed and as such the mean corneal, iris, conjunctical and chemosis
scores were lower than the prescribed cut off scores.
No respiratory irritation data is available
for dipropylene glycol methyl ether. However, as no irritation has been
observed after application to skin and eyes dipropylene glycol methyl
ether is not expected to be a respiratory irritant.
irritation: according to EEC Council Directive 67/548/EEC (amended by
Directive 83/467/EEC) the mean value for erythema and edema scores was 0
for all animals at 24, 48 and 72 hours. According to annex VI of the
directive dipropylene glycol methyl ether is not classified as skin
irritation: according to the annex VI of the council directive 67/548
EEC (amended by directive 83/467 EEC) the average scores over all
opacity, iris lesions, conjunctivae and chemosis were 0.4, 0, 1.4 and
0.6, respectively at 24, 48 and 72 hours. According to EEC criteria no
classification for eye irritancy is required.
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