Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
The skin sensitisation potential of isopropyl chloride was assessed in a GLP-compliant study performed according to OECD Guideline for the Testing of Chemicals No. 406 (Fürst, 1989). In this study, the induction period consisted of intradermal injections and an epicutaneous application. Three pairs of intradermal injections (0.05 mL) were administered to the back of Pirbright Dunkin Hartley guinea pigs (20 animals in the test group and 10 animals in the control group). The 3 injections were composed of the following: 10% isopropyl chloride in vehicle (oleum arachidis), 10% isopropyl chloride in Freund's Adjuvant complete (FCA), or undiluted FCA. The control animals received the vehicle instead of the test compound. After 1 week, a single epicutaneous application of 0.5 mL isopropyl chloride (0.75% in oleum arachidis) was applied for a period of 48 hours. During the challenge period (2 weeks following epicutaneous application), 0.5 mL of isopropyl chloride (75% in Oleum arachidis) was applied to the flank for a period of 24 hours. Control animals were challenged with the vehicle only. No sensitisation reactions were reported at 24 and 48 hours for the test or control animals. It should be noted that the results of a recent positive control test were not reported; however, the results of this test are considered reliable. Therefore, the test compound isopropyl chloride was considered not to cause contact hypersensitivity in guinea pigs.

Migrated from Short description of key information:

Isopropyl chloride was reported to be non-sensitizing to guinea pig skin in a sensitisation test, which was conducted in a GLP-compliant study and performed according to test guidelines.

Justification for classification or non-classification

There is no information available concerning respiratory sensitisation.

 

According to OECD TG 406 the submission substance is not a skin sensitizer. As a result, the substance does not meet the criteria for classification according to Regulation (EC) No 1272/2008, Annex I section 3.4.