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EC number: - | CAS number: -
During the induction, the 10% P-1826 solution was found to be mildly irritating to all animals in the test group, so the remaining 8 doses during the induction were made with a 5% solution.
The report only contains a summary of the results. This reproduced here:
Group II TEST
Group VI Positive Control
Group VIII Negative Control
No. of animals
10% (2 doses), 5% (8 doses)
Challenge Dose or conc.
Time of skin reaction scoring
No. reacted/No. Challenged
a One animal died during the study of an unrelated lung infection
At challenge with 2.5% and 5% solutions of P-1826, none of the animals in the test or negative control groups showed any skin reactions at 24 hours, but the positive control animals showed mild skin reactions at 48 hours.
A standard Buehler assay was conducted on AMP using 30 male guinnea pigs. The animals were separated into 3 groups of 10 animals, a test group,a negative and positive control group. In the Induction phase of the study, the shaved backs and flanks of the test group were exposed to the test compound at a concentration of 10% for 24 hours under an occlusive dressing. At the end of this exposure period the test sites were cleaned and scored for irritation at 24 and 48 hours after exposure. At 48 hours, after the reading of skin irritation, the process was repeated until a total of 10 exposures had occurred. Due to the irritation (mild) caused by 10% test compound the 3rd through to the 10th exposures were done using a 5% concentration.
The positive and negative control groups followed the same procedure, but the animals were exposed to a 0.3% solution of Dinitrochlorobenzene (DNCB) or saline solution respectively.
At the Challenge phase, the test animals and the negative control animals were exposed for 24 hours to 2.5 and 5% test material at 2 previously untreated sites under an occlusive patch. After 24 hours the sites were cleaned and scored for signs of erythema and edema. The sites were scored again at 48 hours. The positive control group and the negative control group were challenged in the same way using a 0.3% concentration of DNCB.
One of the positive control group died during the study due to a lung infection. There were no other mortalities or signs of systemic toxicity observed. In the Test group, at both 24 and 48 hours there was no evidence of inflammation indicative of a sensitising response. In the positive control group 8 out of 9 animals and 3 out of 9 animals gave a positive response at 24 and 48 hours indicating that the positive control worked and that the study is valid. In the negative control group, there was no evidence of irritation or inflammation at the sites treated with the test compound. At 24 hours, 4 out of 10 animals displayed irritation following treatment with DNCB, this irritation had cleared at 48 hours.
Under the circumstances of this study, AMP does not appear to be a skin sensitiser.
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