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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:

No data on skin sensitizing properties of sodium diethyldithiocarbamate (SDEC) in its manufactured form (as 26% aqueous solution) are available. However, Article 13 of the REACH legislation states that, in case no appropriate animal studies are available for assessment, information should be generated whenever possible by means other than vertebrate animal tests, i. e. applying alternative methods such asin vitrotests, QSARs, grouping and read-across.

A reliable GLP-compliant Magnusson-Kligman maximisation assay with a structural analogue of sodium diethyldithiocarbamate (SDEC), sodium dimethyldithiocarbamate (SDMC), in its manufactured and marketed form (as 41.44% aqueous solution) is available (SafePharm Laboratories Limited, 2001c). SDMC is a structural homologue of SDEC, differing only in the carbon chain lengh of the alkyl substituents at the amine function of dithiocarbamate moiety (methyl vs. ethyl). As SDEC, SDMC is manufactured and marketed in aqueous solution with average concentration of 41%. As the concentration of SDEC in solution in its manufactured and marketed form is much lower (max. 26%), and taking into account the structural similarity of two substances, it is considered acceptable to derive information on skin sensitizing properties of SDEC by read-across of SDMC.

In the Magnusson-Kligman maximisation test with SDMC, used as manufactured (as 41.44% aqueous solution), ten male Dunkin-Harley guinea pigs were induced with 5% formulation of the test material in the distilled water intradermally, using 2 rows of 3 injections 0.1 ml each, and epicutaneously on day 7 with 50% of the test substance in distilled water for 48 hours under occlusive dressing. On day 21, animals were challenged epicutaneously with either 50% or 75% solution of the test substance in distilled water for 24 hours under occlusive dressing. Approximately 24 and 48 hours after challenge dressing removal, the skin reactions were scored. One test group animal was found dead on Day 17. The cause of death was not determined and the absence of this animal was considered not to affect the purpose or integrity of the study.

Positive skin responses (discrete or patchy to moderate and confluent erythema - grades 1 or 2) with or without very slight oedema were noted at the topical challenge sites of two test group animals challenged with 75% solution of SDMC at the 24 and 48-hour observations. Discrete or patchy erythema was noted at the challenge sites of four animals of the same group at the 24-hour observation. These reactions were not apparent at the 48-hour observation and were therefore not attributed to contact sensitisation. Other skin reactions noted at the topical challenge sites of two animals challenged with 75% SDMC at the 48-hour observation were small superficial scattered scabs or desquamation.

Discrete or patchy erythema was noted at the challenge sites of five test group animals in the 50% SDMC group at the 24-hour observation. These reactions were not apparent at the 48-hour observation and were therefore not attributed to contact sensitisation. Desquamation was noted at the topical challenge sites of two animals of this group at the 48-hour observation.

No skin reactions were noted at the challenge sites of the control group animals at the 24 or 48-hour observations.

The test material (41.44% aqueous solution of SDMC) produced a 22% (2/9) sensitisation rate and was considered to be a mild sensitiser to guinea pig skin under the conditions of the test. This result does not warrant the classification of SDMC in its manufactured and marketed form (as ca. 41% aqueous solution) as sensitizing. Taking into account that SDEC is manufactured and marketed in more diluted solution (ca. 26%) it is concluded that SDEC in its manufactured and marketed form (as 26% solution) is also not sensitizing. It should be noted that no conclusion on the skin sensitizing properties of the pure (anhydrous) substance can be made based on these data.


Migrated from Short description of key information:
No data on skin sensitizing properties of sodium diethyldithiocarbamate (SDEC) are available. However, based on the available data from the structural analogue sodium dimethyldithiocarbamate (SDMC), tested as 41.44T aqueous solution, for which a reliable GLP-compliant Magnusson and Kligman maximisation test is available, sodium diethyldithiocarbamate in its manufactured and marketed form (as 26%) is concluded not to be sensitizing to skin. As the substance is solely manufactured and marketed as saturated (26%) aqueous solution, it is considered acceptable to use these data for risk assessment and classification and labeling purposes.

Justification for classification or non-classification

Based on the data on the structural analogue sodium dimethyldithiocarbamate (SDMC), which produced 22% (2/9) sensitisation rate in Magnusson-Kligman maximization assay when tested as 41.44% aqueous solution, classification of sodium diethyldithiocarbamate (SDEC) in its manufactured and marketed form (as 26% aqueous solution) as sensitizing is not warranted in accordance with Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.

It should be stated that this classification and labeling are not applicable for the isolated substance; however, as the substance is solely manufactured and marketed as saturated (26%) aqueous solution, the classification as reported above is considered to be acceptable.