Soybean oil, epoxidised, reaction products with methanol and water

Repeated dose toxicity: oral

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

Test material information

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).