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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A skin sensitization study of the test item, HF-1000 Solvent, in guinea pigs was carried out by Nucro-Technics according to Study Plan No. INT/296962. Three groups of Hartley guinea pigs were used. Twenty animals were in the test group, ten animals in the solvent control group and five animals were in the positive control group. The test item, HF-1000 Solvent, was applied “as is” to 2.5 x 2.5 cm gauze patches. The gauze patches were then topically applied for a 6-hour exposure period to the shaved left flanks of 20 guinea pigs on Days 0, 7 and 13. The applications on Days 0, 7 and 13 represented the induction phase of the study. 14 Days after the final induction application (Day 27), a 2.5 x 2.5 cm gauze patch loaded with the test item, HF-1000 Solvent, was applied to the shaved right flank of each animal in the Test Group for a 6-hour exposure period. This application represented the challenge application. A naïve control group, consisting of 10 animals was used. During the induction phase (Days 0, 7, and 13) the left flank of each control animal was shaved and a blank 2.5 x 2.5 cm gauze patch was applied on each animal. On Day 27 (Challenge Phase), the test item, HF-1000 Solvent, was applied to the shaved right flank of each control animal for a 6-hour exposure period. A group of 5 positive control animals was subjected to identical procedures as outlined above for the test group of animals (induction phase), with the exception that the positive control item, 0.3% 1-chloro-2, 4-dinitrobenzene (DNCB), was substituted as a reference substance. During the challenge phase, the positive control item (0.1% DNCB) was applied to the shaved right flank of each positive control animal. An evaluation of skin reaction was carried out and recorded at 24 hours and 48 hours after completion of each application. None of the guinea pigs administered the test item had any signs of local skin irritation after the induction applications or after the challenge period. All 5 of the positive control animals showed a positive response. Based on these findings, the test item, HF-1000 Solvent, was found to be non-sensitizing in a Buehler Skin Sensitization Study in guinea pigs


Migrated from Short description of key information:
he test item, HF-1000 Solvent, was found to be non-sensitizing in a Buehler Skin Sensitization Study in guinea pigs

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