of Irritation Intradermal injection: An examination of the injections was performed one and 24 hours after treatment. On both dates weak dermal reactions were observed at the test group animals and all but three control group animals showed no effects. Topical induction: In the test group animals, one hour after the exposure ended, weak to moderate skin reactions were observed and after 24 hours weak skin reactions were seen. The control group animals also showed weak skin reaction on both times. challenge phase topical: 2% (v/v) with Paraffine perliquid Remarks - Method No significant protocol deviations. The study report was a translation. Animal Challenge Concentration Number of Animals Showing Skin Reactions after challenge 24 h 48 h Test Group 2% 1/20 1/20 Control 0 0/10 0/10 Remarks - Results 24 and 48 hours after termination of the challenge moderate skin reactions were observed in 19 test group animals and in the 10 control group animals. Neither test group animals nor control group animals died during the study and no significant difference was observed in their body weights. The observed effects occurring in both control and test animals may be due to irritation. Such irritation effects would mask any sensitisation effects if they were present. No conclusion can be from this study as to the sensitising potential of the analogue chemical (commercial form). Henkel KGaA (1991a) 7.6.2 Skin sensitisation Analogue chemical (commercial form) OECD TG 406 Skin Sensitisation Buehler Test. – Species/Strain Guinea pig/Pirbright white/Charles River preliminary study Maximum Non-irritating Concentration: topical: 15%,(w/w) in saline (minimally irritating) main study Number of Animals Test 10 Control Group: 10 induction Induction Concentration: Topical: 15% Signs of Irritation One hour terminating the third induction, 6 test group animals showed slight and one moderate effects on the exposed skin area. 24 hours later 9 test group animals showed up to strong effects. The control group animals showed no dermal alterations on the treated skin areas at any time. challenge phase challenge topical: 5% Remarks - Method No positive controls were included in the A rechallenge was not performed.
of Irritation Intradermal injection: An examination of the injections was performed one and 24 hours after treatment. On both dates weak dermal reactions were observed at the test group animals and all but three control group animals showed no effects. Topical induction: In the test group animals, one hour after the exposure ended, weak to moderate skin reactions were observed and after 24 hours weak skin reactions were seen. The control group animals also showed weak skin reaction on both times. challenge phase topical: 2% (v/v) with Paraffine perliquid Remarks - Method No significant protocol deviations. The study report was a translation. Animal Challenge Concentration Number of Animals Showing Skin Reactions after challenge 24 h 48 h Test Group 2% 1/20 1/20 Control 0 0/10 0/10 Remarks - Results 24 and 48 hours after termination of the challenge moderate skin reactions were observed in 19 test group animals and in the 10 control group animals. Neither test group animals nor control group animals died during the study and no significant difference was observed in their body weights. The observed effects occurring in both control and test animals may be due to irritation. Such irritation effects would mask any sensitisation effects if they were present. No conclusion can be from this study as to the sensitising potential of the analogue chemical (commercial form). Henkel KGaA (1991a) 7.6.2 Skin sensitisation Analogue chemical (commercial form) OECD TG 406 Skin Sensitisation – Buehler Test. Species/Strain Guinea pig/Pirbright white/Charles River preliminary study Maximum Non-irritating Concentration: topical: 15%,(w/w) in saline (minimally irritating) main study Number of Animals Test 10 Control Group: 10 induction Induction Concentration: Topical: 15% Signs of Irritation One hour terminating the third induction, 6 test group animals showed slight and one moderate effects on the exposed skin area. 24 hours later 9 test group animals showed up to strong effects. The control group animals showed no dermal alterations on the treated skin areas at any time. challenge phase challenge topical: 5% Remarks - Method No positive controls were included in the A rechallenge was not performed.
STD-1033-FR.docx