Registration Dossier
Registration Dossier
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EC number: 211-745-8 | CAS number: 693-21-0
Endpoint summary
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 ‘Classification’ in 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 ‘Classification’ in 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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