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Toxicological information

Carcinogenicity

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Administrative data

Endpoint:
carcinogenicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Chronic toxicity studies on two epoxidized soybean oils in the rat and dog
Author:
Larson
Year:
1960
Bibliographic source:
Toxic. Appl. Pharm. 2: 649-658.

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Groups of rats (15/sex) were given diets containing up to 5% ESBO for up to 2 years. Five rats/sex/group were sacrificed at 6 months. Organ to body weight measurements were made for liver, kidney and testes. Blood studies (hemoglobin, red blood cell and differential white cell counts) were made
during the eleventh and twenty-fourth months. Histopathology of heart, lung, kidney, spleen, gastroenteric, thyroid, adrenal, pancreas, gonad, muscle and bone marrow tissues was conducted on survivors from the 0, 2.5% and 5% diet groups
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Specifications for Paraplex G62 composition:
Typical Spec limits
Spec limits
Acid Value mg KOH/g 0.3 0 - 1.0
Iodine Value 10 6 - 14
Oxirane Oxygen 6.5 6.3 - (max not given)

The conversion from % in diet to dosage as an approximate mg/kg bw/day is:
% in diet approximate mg/kg bw/day
0 0
.1 25
.5 125
1 250
2.5 625

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
not specified
Details on exposure:
Groups of rats (15/sex) were given diets containing up to 5% ESBO for up to 2 years.
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
2 years
Frequency of treatment:
no data
Doses / concentrations
Remarks:
Doses / Concentrations:
0,0.1,0.5,1,2.5,5 &%
Basis:

No. of animals per sex per dose:
15
Positive control:
Five rats/sex/group were sacrificed at 6 months. Organ to body weight measurements were made for liver, kidney and testes. Blood studies (hemoglobin, red blood cell and differential white cell counts) were made
during the eleventh and twenty-fourth months. Histopathology of heart, lung, kidney, spleen, gastroenteric, thyroid, adrenal, pancreas, gonad, muscle and bone marrow tissues was conducted on survivors from the 0, 2.5% and 5% diet groups

Examinations

Observations and examinations performed and frequency:
Organ to body weight measurements were made for liver, kidney and testes. Blood studies (hemoglobin, red blood cell and differential white cell counts) were made during the eleventh and twenty-fourth months. Histopathology of heart, lung, kidney, spleen, gastroenteric, thyroid, adrenal, pancreas, gonad, muscle and bone marrow tissues was conducted on survivors from the 0, 2.5% and 5% diet groups
Sacrifice and pathology:
no data
Statistics:
no data

Results and discussion

Results of examinations

Details on results:
Organ to body weight measurements were made for liver, kidney and testes. Blood studies (hemoglobin, red blood cell and differential white cell counts) were made during the eleventh and twenty-fourth months. Histopathology of heart, lung, kidney, spleen, gastroenteric, thyroid, adrenal, pancreas, gonad, muscle and bone marrow tissues was conducted on survivors from the 0, 2.5% and 5% diet groups

Applicant's summary and conclusion

Conclusions:
ESBO is assumed to be non carcinogenic