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EC number: 201-506-6 | CAS number: 83-86-3
3.3 Preliminary irritation tests
It was not considered necessary to adjust the pH of the test material for the sensitization
test as the results of the preliminary irritation tests showed that the irritancy of phytic acid
was not significantly altered and the concentrations selected would be the same.
As a result of the preliminary irritation tests, 0.1 % a.i. was selected from the preliminary
irritation test to be the highest suitably irritant concentration for the intradermal injection
induction. From the preliminary occluded patch test, 5.0% a.i. was selected as it was the
highest suitably irritant concentration for the patch induction. 2.5% a.i was selected as
the highest non-irritant concentration for the challenge patch. The results are given in
3.4 Sensitization test
The test and control guinea pigs showed intense (grade 3) erythema reactions to the
induction injection and induction application treatments. The individual scores for the test
animals are given in Table 2 and the control animals in Table 3.
There was no evidence of sensitization reactions in any of the twenty test guinea pigs
challenged with 2.5 % phytic acid at challenge 1.
Control animal B9 showed a minor irritation reaction to the test material at the 24 hour
assessment, the rest of the control animals showed no response. Test animal All showed
a minor irritation reaction to the test material at the 24 hour assessment.
The results are summarised in Table 1. Individual animal data for the challenge treatment
is given in Table 4 for the test animals and Table 5 for the control animals.
The study following the principles of OECD 406 (1993) (Magnusson & Kligman Maximization test) was performed to determine the potential of phytic acid to induce skin sensitization reactions.
Sensitization was induced in guinea pigs by intradermal injections of both test substance and Freund Is Complete Adjuvant. Seven days later the induction process was supplemented by application of the test substance to the shoulder injection sites under occlusion for 48 hours. Fourteen days later the guinea pigs were challenged by a 24 hour occluded patch of the test substance, the treatment sites were then examined for evidence of sensitization 24 and 48 hours after removal of the challenge patch.
The test and control guinea pigs showed intense (grade 3) erythema reactions to the induction injection and induction application treatments.
There was no evidence of sensitization reactions in any of the twenty test guinea pigs challenged with 2.5 % phytic acid at challenge 1.
One control animal showed a minor irritation reaction to the test material at the 24 hour assessment, the rest of the control animals showed no response. Test animal . All animals showed a minor irritation reaction to the test material at the 24 hour assessment.
Under the conditions of this study, phytic acid was classed as a non-sensitiser.
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