Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 211-063-0 | CAS number: 628-96-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Toxicity to reproduction
Administrative data
- Endpoint:
- three-generation reproductive toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The SIDS rating for this study is "Very Good but lacking some of the measurements called for in the current OECD Guideline" Only the SIDS summary for this study was available for review (data provided was limited)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: FDA Guidelines (1966)
- Deviations:
- not specified
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Glycerol trinitrate
- EC Number:
- 200-240-8
- EC Name:
- Glycerol trinitrate
- Cas Number:
- 55-63-0
- Molecular formula:
- C3H5N3O9
- IUPAC Name:
- propane-1,2,3-triyl trinitrate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River CD albino
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on mating procedure:
- F0 group consisted of 10 males and 20 females cohabited for 14 days. F1a group was discarded and the F0 group remated. Twenty to 24 apparently normal offspring (F1b) of each sex were randomly selected in approx. equal numbers from each group and mated 1 / 1 with rats from the same group. The same procedure was followed with the F2 group. The F3b group was sacrificed after weaning and the overt physical and reproductive parameters called for in the FDA Guideline were evaluated.
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- Females were dosed during pregnancy and between matings. Males were dosed until successful delivery of each “b” generation (the "a" generations were discarded).
- Frequency of treatment:
- Females were dosed during pregnancy and between matings. Males were dosed until successful delivery of each “b” generation (the "a" generations were discarded).
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0.01%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
0.1%
Basis:
nominal in diet
- Remarks:
- Doses / Concentrations:
1.0%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 24 animals per sex per dose
- Details on study design:
- F0 group consisted of 10 males and 20 females cohabited for 14 days. F1a group was discarded and the F0 group remated. Twenty to 24 apparently normal offspring (F1b) of each sex were randomly selected in approx. equal numbers from each group and mated 1 / 1 with rats from the same group. The same procedure was followed with the F2 group. The F3b group was sacrificed after weaning and the overt physical and reproductive parameters called for in the FDA Guideline were evaluated.
The F3b group was sacrificed after weaning and the overt physical and reproductive parameters called for in the FDA Guideline, were evaluated. Prostate weights of male progeny were not determined. Sperm morphology, motility and histopathologic effects were not determined for the F1 andF2 generations. As usual, rats in each cage were examined daily.
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: No data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
Control analyses were carried out over eight-day periods to measure evaporation of NG from the diet under cage conditions during the week. GC also was used for these analyses, but with a 63Ni detector. This information was used to calculate actual dosage received by the rats. Feeders were topped off with fresh diet on the fourth day of each week, and diet in each feeder was replaced totally every seven days. The feed for the control rats contained 10 % (w/w) of diet that had been dried to 0.1 % water content. - Oestrous cyclicity (parental animals):
- No data
- Sperm parameters (parental animals):
- No data
- Litter observations:
- No data
- Postmortem examinations (parental animals):
- No data
- Postmortem examinations (offspring):
- No data
- Statistics:
- Mean or mean ± standard error
- Reproductive indices:
- No data
- Offspring viability indices:
- No data
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- decreased feed consumption in females (F1b gestation)
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- decreased feed consumption in females (F1b gestation)
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 46 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: All generations
- Dose descriptor:
- LOAEL
- Effect level:
- 452 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: decreased feed intake in dams during F1b gestation resulted in decreased litter size and birth weights
- Dose descriptor:
- NOAEL
- Effect level:
- 39 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: not specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- decreased body weight
- Sexual maturation:
- effects observed, treatment-related
- Description (incidence and severity):
- aspermatogenesis in F2a males
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
Results: F2 generation
Effect levels (F2)
- Dose descriptor:
- LOAEL
- Generation:
- F2a
- Effect level:
- 408 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: aspermatogenesis leading to infertility
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.