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:

Only one study, a Draize test on guinea pigs, was available. It was with validity 2 and was selected as key study.

In thisdermal sensitization study (Sharp, 1978) with Paradimethoxybenzene, males and females Hartley guinea pigs  (5/sex) were tested in a modified Draize test. A 0.1 ml aliquot of test material, at 2.5 times the ICC, was injected intradermallyat 4sites which overlie the 2 auxiliary and 2 inguinal lymph nodes. The guinea pigs were challenged 14 days later by an intradermal injection of 0.1 ml test material into one flank and a topical open application of test material on the other flank at the respective injection challenge concentration (ICC) and application challenge concentration (ACC). Reactions were scored 24 hours after challenge treatments.

In absence of sensitization reactions, second induction and challenge procedures were repeated and a confirmatory challenge with controls was included. At each challenge with controls, 4 previously untreated animals of the same sex and similar weight to the test animals were treated intradermally and topically on opposite flanks with 0.1 ml aliquots of test substance at the ICC and ACC respectively. Reactions were examined under a Philips colour-matching unit. Each injection was given a total score based on size (2 largest diameters), erythema and oedema. Individual reactions were considered positive when their total score was significantly greater than the average total score for control reactions. 

No positive reaction were observed.

In this study, Paradimethoxybenzene is not a skin sensitizer.

This result was confirmed in results on Human data (see section 7.10.4) on studies considered as validity 4 (only summaries available).


Migrated from Short description of key information:
Paradimethoxybenzene is not sensitizing on guinea pigs, in Draize test.

Justification for classification or non-classification