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Administrative data

Description of key information

One chronic study for DEGDN was found in form of publication. This publication contains no detailed description (reliability "3"). The no-effect level was determined to be 0.05 mg/kg/day.
Three chronic studies for Trinitroglycerin in dogs, rats and mice were used for read-across (NOAEL (dog) - under conditions of this study, there was no NOAEL, in either sex, NOAEL (rat - prefered animals for repeated dose toxicity study) - 3.04-3.99 mg/kg bw/day, NOAEL (mice) - 96.4-114.6 mg/kg bw/day)
DEGDN has classification harmonized in Annex VI of CLP as STOT RE 2*.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
NOAEL
3.04 mg/kg bw/day
Study duration:
chronic
Species:
rat

Additional information

The chronic study for DEGDN - the no-effect level (NOAEL) was determined to be 0.05 mg/kg/day. The reliability of study is "3".

The chronic studies for Trinitroglycerin:

NOAEL (dog) - under conditions of this study, there was no NOAEL, in either sex,

NOAEL (rat - prefered animals for repeated dose toxicity study) - 3.04-3.99 mg/kg bw/day,

NOAEL (mice) - 96.4-114.6 mg/kg bw/day)

DEGDN has classification harmonized in Annex VI of CLP as STOT RE 2*. Guidance values to assist in Category 2 classification for specific target organ toxicity-repeated exposure are 10 < C ≤ 100 mg/kg bw/day.

The classification indicated by the reference *in Annex VI in the column Classificationin Table 3.1 shall be considered as a minimum classification.This classification shall be applied if none of the conditions stated in Annex VI (1.2.1) are fulfilled. These conditions are not fulfilled for DEGDN due to quality of available information for repeated toxicity.

The NOAEL value used for the Risk assessment is NOAEL (rat-male) 3.04 mg/kg bw/day.

Justification for classification or non-classification

DEGDN has classification harmonized in Annex VI of CLP as STOT RE 2*. Guidance values to assist in Category 2 classification for specific target organ toxicity-repeated exposure are 10 < C ≤ 100 mg/kg bw/day.

The classification indicated by the reference *in Annex VI in the column Classificationin Table 3.1 shall be considered as a minimum classification.This classification shall be applied if none of the conditions stated in Annex VI (1.2.1) are fulfilled. These conditions are not fulfilled for DEGDN due to quality of available information for repeated toxicity.