N-nitro-N-(3-methyl-3,6-dihydro-2H-1,3,5-oxadiazin-4-yl)amine

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Only when transient irritant effects are included in the scoring, the substance is, borderline, sensitizing.

Migrated from Short description of key information:
This study was performed in compliance with Good Laboratory Practice (GLP) in , Procedures and Principles, March 1986. These procedures are based on the OECD Principles of GLP, adopted May 12, 1981 by Decision of the OECD Council C(81)30(Final).
The study has been conducted according to OECD guideline 406 adopted July 17, 1992, by the OECD council, and on Annex V, part B of Council Directive 67/548/EEC (Commission Directive 92/69/EEC of July 31, 1992).
A guinea pig maximisation test was initiated to determine sensitising properties of CA 2343 A (Intermediate of CGA 293343) after challenge exposure by skin contact. The procedure of Magnussen and Kligman for adjuvant tests was followed.

Epidermal challenge of 10 male and 10 female guinea pigs (test groups) resulted in positive responses in 6 (3 males, 3 females) animals after 24 hours and in 4 (2 males, 2 females) animals after 48 hours. Very slight erythema reactions in 1 male and 1 female faded after the scoring at 24 hours and were recognised as transient irritation (false-positive reaction) based on clinical appearance and duration. Scaling was recorded in 2 male animals (No. 126 and 134) after 48 hours. No irritant skin reactions were recorded for control animals. The sensitization rate was 30% including transient irritant reactions.

Body weights were recorded at start and on conclusion of the test and tabulated with means and standard deviations. Body weights were not affected by the treatment.

Based on the sensitization rate of 30% including transient irritant reactions, which is at the threshold of significance set in Commission Directive 93/21/EEC (18th adaptation to technical progress of Council Directive 67/548/EEC), CA 2343 A (Intermediate of CGA 293343) has to be labelled “May cause sensitization by skin contact”.

Justification for classification or non-classification

Because the transient irritant effects the substance is borderline positive substance was classifieds as 'may cause sensitization by skin contact'.

However, if the transient irritant effects are regarded as irritant, rather than as sensitizing effects, the substance would be classified as 'not sensitizing'.