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Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 weeks
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
review article or handbook
Title:
No Evidence of Toxicity or Carcinogenicity of Pentaervthritol Tetranitrate Given in the Diet to F344 Rits and B6C3F1 Mice for up to Two years
Author:
John R. Bucher, James Huff, Joseph K. Haseman and Scot L. Eustis
Year:
1990
Bibliographic source:
Journal of applied toxicology, Volume: 10 (1)

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female

Administration / exposure

Route of administration:
oral: drinking water
Vehicle:
water
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
daily
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:3100 ppmBasis:nominal in diet
Remarks:
Doses / Concentrations:6200 ppmBasis:nominal in diet
Remarks:
Doses / Concentrations:12500 ppmBasis:nominal in diet
Remarks:
Doses / Concentrations:25000 ppmBasis:nominal in diet
Remarks:
Doses / Concentrations:50000 ppmBasis:nominal in diet
No. of animals per sex per dose:
10 males and 10 females
Control animals:
yes

Examinations

Observations and examinations performed and frequency:
Cage side observations: No dataDermal irritation: No dermal study Body weight: Yes, female rats receiving diets containing 5000 or 10 000 ppm weighted 6-7% less than controlsFood consumption and compound intake: No dataFood efficiency: No dataWater consumption and compound intake (if drinking water study): No dataOphthalmoscopic examination: No dataHaematology: No effectsClinical chemistry: No effectsNeurobehavioural examination: No effects
Sacrifice and pathology:
Gross pathology: No effectsHistopathology: An adenoma of the Zymbal gland was observed in 1/10 high-dose female rats

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
Female rats receiving diets containing 5000 or 10 000 ppm weighted 6-7% less than controls
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
effects observed, treatment-related
Description (incidence and severity):
Low increase of adenoma of the Zymbal gland

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
<= 50 000 mg/kg diet
Based on:
test mat.
Sex:
male
Basis for effect level:
body weight and weight gain
Dose descriptor:
NOAEL
Effect level:
> 12 500 - <= 25 000 mg/kg diet
Based on:
test mat.
Sex:
female
Basis for effect level:
body weight and weight gain

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Effects on the animals cannot be attributed to the ingestion of PETN.