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EC number: 204-411-8
CAS number: 120-61-6
No evidence of skin irritation was seen in a modern, guideline-compliant study; findings are supported by evidence from a number of non-standard studies. No evidence of eye irritation was seen in four non-standard studies. In the absence of any effects on the skin or eye, it is considered unlikely that DMT is a respiratory irritant.
The irritant potential of Dimethyl terephthalate (DMT) was determined
according to ES EPA guidelines (and comparable to OECD 404). A single 4
hour, semi-occluded application of DMT to the skin of six male New
Zealand White rabbits produced no evidence of skin irritation. The test
material produced a primary index of 0.0 and is not classified as
irritating to rabbit skin (Anonymous, 1989).
The dermal irritation of DMT has been further investigated in a number
of non-standard older studies, however the results are largely
consistent and do not demonstrate that the substance is a skin irritant.
Findings in a study in which guinea pigs were exposed to mositened DMT
at a level of 1 and 2 g/kg for 24 hours under occlusive conditions were
limited to very slight skin irritation (Perry, 1957). In a further
non-standard study, DMT moistened with water (0.1 -5 g/kg bw) was
applied for 24 hours under occlusive conditions to the skin of groups of
guinea pigs. One animal died as a consequence of the application
procedure. No findings were observed with the exception of 'erythematous
pits' caused by embossed particles in the skin. At one week, hairloss
and 'very little' desquamation was reported. The application site was
reported to be normal at 2 weeks (Shaw, 1958). In a non-standard study
in rats and mice (Sanina & Kocketkova, 1963), DMT (5% starch) was
applied to the rabbit's shorn skin for two hours. For the mice, the
tails were immersed into a test tube filled with a suspension of
terephthalate in 5% starch. A single exposure lasted two hours. The
application was repeated ten times. In rabbits, reddening of the skin
was observed on the third application, followed by a change in
pigmentation on day 10. By 12 days the skin was back to normal. A
similar reaction was seen in mice. Repeated application resulted in
slight hyperaemia after the third exposure. Behavioural changes were
also noted. Again, by day 12 the skin and behaviour had returned to
normal. In a 1961 study conducted by BASF, the test
susbtance dimethyl terephthalate (DMT) was tested in Vienna White
rabbits. The test substance was applied at a concentration of
approximately 2g in 50% solution in water, occlusively to the dorsal
region and the ear of each rabbit. There were no treatment related
abnormalities observed following treatment with the test susbtance at
any of the time points examined.
In a guideline-compliant study, a single dose of 50 mg DMT was instilled
into the conjunctival sac one eye of 8 rabbits. The eyes were washed
with water after five minutes or 24 hours. No evidence of ocular
irritation was reported. Three further eye irritation studies are
available. They do not follow standard methodology however they contain
some useful information regarding the eye irritant properties and
clearly indicate that the substance is not irritating to eyes. Perry
(1957) found that one drop of an aqueous slurry of the test substance
instilled into the conjunctival sac of a single rabbit's eye caused no
irritation or damage. In another study conducted at the same laboratory,
Shaw (1958) found that one drop of an aqueous slurry placed into the
conjunctival sac of the rabbit's eye resulted in only a slight immediate
discomfort. No signs of pathology or signs of continued irritation were
noted in the eye. In a published study by Sanina and Kochetkova (1963),
a suspension of two drops of dimethyl terephthalate in 5% starch was
placed into the conjunctival sac of four rabbits. The rabbits were
observed for signs of irritation for 2 days. The test substance caused
reddening of the conjunctiva immediately after administration, all signs
of irritation had disappeared by the next day. It is also notable that
the toxicokinetic study of Moffit et al (1975) did not identify
any local effects following installation of DMT.
In a study conducted by BASF in 1961, 50 mg of the test
substance was applied to the right eye of each of 2 test rabbits of the
Vienna White strain. The left eye of each animal served as the control
and talcum was applied. The
test substance resulted in slight redness of the treated eye in both
animals 10 minutes post application. After examination at 3 hours,
redness was still present. Slight swelling was noted in 1 animal after 3
hours. Within 24 hours of application, all observed symptoms had
completely reversed in both test animals.
No data are available. In the absence of any effects on the skin or eye,
it is considered unlikely that DMT is a respiratory irritant.
In a GLP guideline study, there was no evidence that dimethyl
terephthalate was irritating to the skin or rabbits; no evidence of
marked irritation is reported in a number of non-standard studies. The
available eye irritation studies do not report any notable irritation.
DMT therefore does not warrant classification as a skin or eye irritant
according to Regulation (EC) No. 1272/2008.
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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