Registration Dossier

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
chronic toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
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 PS
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
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Soybean oil, epoxidized
EC Number:
232-391-0
EC Name:
Soybean oil, epoxidized
Cas Number:
8013-07-8
IUPAC Name:
8013-07-8
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 oral 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
Details on study design:
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
Positive control:
no data

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

Body weight and weight changes:
effects observed, treatment-related
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Details on results:
Growth appeared to be essentially normal at 2.5%, but appeared to be permanently low in the 5% group. A limited evaluation of the blood (red blood cell and white blood cell counts) revealed no effects. Liver weight was increased in both sexes at 1% and above. There was some evidence that kidney weight was increased in the females at 1% and above. Microscopic examination of the major tissues revealed no cellular changes at 2.5% or 5% (only dose groups examined).

Effect levels

Dose descriptor:
LOAEL
Effect level:
ca. 250 mg/kg bw/day (actual dose received)

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Growth appeared to be essentially normal at 2.5%, but appeared to be permanently low in the 5% group. A limited evaluation of the blood (red blood cell and white blood cell counts) revealed no effects. Liver weight was increased in both sexes at 1% and above. There was some evidence that kidney weight was increased in the females at 1% and above. Microscopic examination of the major tissues revealed no cellular changes at 2.5% or 5% (only dose groups examined).

Categories Display