Registration Dossier

Diss Factsheets

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:

A human study using EGDN is available indicating that EGDN has a low skin sensitising potential.

Skin sensitization may be observed in some patients exposed to EGDN (Kanerva et al. 1991). However, the likelihood of occurrence among the exposed population appears to be low.

The guinea pig study conducted with NG suggests that NG is sensitizing.

Guinea pigs (10 per group) were first sensitized intradermally on d0, and again topically on d7 (Lee et al. 1975). On d21 the animals were challenged topically with a closed patch for 24 h and readings were taken 24 h and 48 h post-challenge. A control group received the same induction and challenge applications excluding the test agent (generic guinea pig maximization test description).Using a dermal application of 3.41% NG in lactose/peanut oil carrier, “moderate” skin sensitization was observed in 40% of guinea pigs in the treatment group. However, the study is not valid (Klimisch 3) since there is no information on the animal strain used, no information on the induction and elicitation concentrations and information is lacking on the reactions of control animals. This evaluation is in line with the assessment of the German MAK commission, which also considered the guinea pig test as not reliable and not valid (MAK Value Documentation - Glycerintrinitrat, 2006).

Overall, it is concluded that EDGN does not warrant a classification for skin sensitisation. This is in line with the current entry in Annex VI Table 3 of Regulation (EU) 1272/2008.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No studies specifically assessing respiratory sensitization for EGDN or NG (read-across) were available. But, given that no secondary sources reporting on inhalation exposures identified respiratory sensitization as an adverse effect, EGDN is not considered to be a likely respiratory sensitizer.

Justification for classification or non-classification

Categories Display