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EC number: 413-110-2 | CAS number: 135861-56-2
lntradermal and Topical Sighting Tests
Intradermal sighting test- summary of results. Vehicle: arachis oil BP
Time of observation
Concentration of test material (% w/v)
Grade of erythema at injection sites
Evidence of systemic toxicity
E= eschar; N= green necrosis; N*= possible necrosis
Topical sighting test for induction application (48-h exposure)- individual skin reactions. Vehicle: arachis oil BP
Concentration of test material (% w/w)
Skin reaction (hours after removal of patches)
Er= erythema; Oe= oedema; -= no other reactions noted; D= desquamation; *= maximum attainable concentration suitable for topical application
Topical sighting test for challenge application (24-h exposure)- individual skin reactions. Vehicle: arachis oil BP
Er= erythema; Oe= oedema; -= no other reactions noted; *= maximum attainable concentration suitable for topical application
Based on these results, the following concentrations were selected for the main study:
Intradermal induction: 0.5 % w/v in arachis oil BP
Topical induction: 25 % w/w in arachis oil BP
Topical challenge: 10 % and 5 % w/w in arachis oil BP
-Skin Reactions Observed After lntradermal lnduction:
Well-defined erythema was noted at the intradermal induction sites of all test group animals at the 24 and 48-hour observations. Very slight erythema was noted at the intradermal induction sites of all control group animals at the 24-h observation and in 4 control group animals at the 48-h observation.
-Skin Reactions Observed After Topical lnduction:
Very slight to well-defined erythema was noted at the induction sites of all test group animals at the 1-h observation with very slight erythema at the induction sites of 9 test group animals at the 24-h observation. Bleeding from the intradermal induction sites was noted in 5 test group animals at the 1-h observation. Residual test material was noted in all test group animals. Bleeding from the intradermal induction sites was noted in 1 control group animal at the 1-h observation. No signs of erythema or oedema were noted at the treatment sites of control group animals at the 1 and 24-h observations.
-Skin Reactions Observed After Topical Challenge:
No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48-h observations.
Bodyweight gains of guinea pigs in the test group, between Day 0 and Day 24, were comparable to those observed in the control group animals over the same period.
A study was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. The study was performed in compliance with the OECD Guidelines for Testing of Chemicals No. 406 "Skin Sensitisation" and Method B6 of Commission Directive 92/69/EEC.
Ten test and five control animals were used for the main study.
Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as follows:
- lntradermal lnduction: 0.5 % w/v in arachis oil BP
- Topical lnduction: 25 % w/w in arachis oil BP
- Topical Challenge: 10 % and 5 % w/w in arachis oil BP
The test material produced a 0 % (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin.
Skin sensitisation: The test material did not meet the criteria for classification as a skin sensitiser according to Regulation 1272/2008 as it produced a 0% sensitisation rate.
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