Registration Dossier
Registration Dossier
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EC number: 201-084-3 | CAS number: 78-11-5
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: USEPA OPPTS 870.3550 Reproduction/Developmental Toxicity Screening Test
- GLP compliance:
- yes
- Remarks:
- This study was conducted consistent with the standards found in Title 40 US Code of Federal Regulations (CFR), Part 792, Good Laboratory Practices.
Test material
- Reference substance name:
- Pentaerithrityl tetranitrate
- EC Number:
- 201-084-3
- EC Name:
- Pentaerithrityl tetranitrate
- Cas Number:
- 78-11-5
- Molecular formula:
- C5H8N4O12
- IUPAC Name:
- 3-(nitrooxy)-2,2-bis[(nitrooxy)methyl]propyl nitrate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- 56 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:0 mg PETN/kgBasis:nominal in diet
- Remarks:
- Doses / Concentrations:100 mg PETN/kgBasis:nominal in diet
- Remarks:
- Doses / Concentrations:500 mg PETN/kgBasis:nominal in diet
- Remarks:
- Doses / Concentrations:1000 mg PETN/kgBasis:nominal in diet
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
Examinations
- Parental animals: Observations and examinations:
- DETAILED CLINICAL OBSERVATIONS: Yes - Time schedule: at least once a day, and more frequently when signs of toxicity are observed. The duration of gestation was recorded and calculated from day 0 of pregnancyBODY WEIGHT: Yes - Time schedule for examinations: Males and females were individually weighed the day before and on the first day of dosing, weekly thereafter, and at termination of the study.FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes - Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
- Sperm parameters (parental animals):
- PARAMETERS EXAMINED IN [MALE PARENTAL GENERATIONS [testis weight, epididymis weight, daily sperm production, sperm count in testes, sperm count in epididymides, enumeration of cauda epididymal sperm reserve, sperm motility, sperm morphology, other:]
- Litter observations:
- Each litter was examined as soon as possible after delivery to establish the number and sex of pups,still births, live births, and runts (pups that are significantly smaller than corresponding control pups), and the presence of gross abnormalities. Live pups were counted and sexed, and litters weighed within 24 hr of parturition (day 1) and on day 4 post-partum.
- Postmortem examinations (parental animals):
- SACRIFICE: No rats died due to PETN toxicityGROSS NECROPSY: animals were examined for any abnormalities or pathological changes, with special attention being paid to the reproductive organs.HISTOPATHOLOGY / ORGAN WEIGHTS: Testes, epididymides, and ovaries were fixed in Bouin�s fixative, embedded in paraffin, cut into transverse sections of 4�5 mm thickness, and stained with PAS and hematoxylin.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- 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)
- Dose descriptor:
- NOAEC
- Effect level:
- >= 1 000 ppm
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- effects observed, non-treatment-related
- Dermal irritation (if dermal study):
- not examined
- Mortality / viability:
- not examined
- Body weight and weight changes:
- not examined
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings:
- not examined
- Other effects:
- not specified
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Effect levels (F1)
- Dose descriptor:
- dose level: Pups received PETN only through lactation.
- Generation:
- F1
- Effect level:
- > 100 - < 500 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- body weight and weight gain
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- No adverse effects on development or reproduction from PETN exposure were observed.
- Executive summary:
Sprague-Dawley rats were exposed to oral daily adjusted volumetric doses of 0, 100, 500, or 1,000mg PETN/kg body mass in a corn oil vehicle for up to 56 days. Mating, duration of gestation, body weight, feed consumption, overall condition of adults, and the number, sex, and condition of pups were recorded. Histological examinations were also performed on the ovaries, testes, and epididymides of animals from the control and the highest dose groups. Only body weights
and feed consumption were affected by treatment; however, these differences may be attributed more to volumetric adjustments of vehicle in the control and high-dose groups than to PETN toxicity. No adverse effects on development or reproduction from PETN exposure were observed.
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