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EC number: 236-244-1
CAS number: 13254-34-7
DIMETOL was evaluated for its potential skin sesitization capacity prior
to the availability of the LLNA protocol. A guinea pig study using an
intradermal method of induction with Freund's Complete Adjuvant elicited
no sensitization responses in 10 animals upon challenge with a 20%
solution of DIMETOL. Three, separate human repeat patch tests were
conducted with DIMETOL. In the first study, a modified Draize procedure,
10 panelists displayed no sensitization reactions to a 5% solution of
DIMETOL in denatured ethanol. In the second study, also a modified
Draize protocol, 53 subjects exhibited no sensitization reactions from a
2% solution of DIMETOL in dimethyl phthalate. The third and final study
employed a Maximization protocol with 25 subjects and a 10% solution of
DIMETOL. No sensitization reactions were reported under these
conditions. The classification criteria for skin sensitization are not
Fifty three subject, 35 female and 18 male, of representative age groups
concluded a full sensitization and challenge test study in accordance
with the described Draize repeated insult technique. There were no
reactions manifested by any one of these subjects in the challenge test
to any one of the eight prepatations in the challenge test and there
were no significant reactions of either an irritative or allergenic
character by any of the individuals in response to any of these
preparation during the sensitization phase of the study.
Minor adhesive tape reactions were recorded but not repeated during the
It is therefore concluded that the eight preparations studied in this
investigation are not primary irritants in the concentrations employed
and that in these concentrations they were not allergenic to any of the
53 subjects who completed the full study.
Results of the study are shown in the tables in the attached study as
Table 1: Individual reaction scores and group totals following patch
application of sample.
Table 2: Allergies, dermatitides and concomitant medication for each
The irritation and sensitizing properties of the test sample listed
above were evaluated in 10 male and female panelists in a repeated
insult patch test.
The 10 panelists showed little or no primary irritation.
There was no evidence of sensitization to the sample under conditions of
Not sensitized 10/10
Possibily sensitized 0/10
Probably sensitized 0/10
The DSD and GHS classification criteria for skin sensitization are not
met for DIMETOL. No evidence of sensitization was seen in an intradermal
guinea pig study, and in three separate human patch tests using either a
modified Draize procedure or a Maximization protocol.
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