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Diss Factsheets

Toxicological information

Toxicity to reproduction

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Administrative data

Endpoint:
fertility, other
Remarks:
based on test type (migrated information)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
April to July 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Studies performed and report issued and peer-reviewed as part of the National Toxicology Program under auspicion of U.S. Department of Health and Human Services, Public Health Service, National Institutes of Health.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Examination of fertility parameters in 90-d repeated toxicity tests.
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Castor Oil

Test animals

Species:
other: rat and mouse
Strain:
other: F344/N rats; B6C3F1 mice
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test Animals:
Source: Simonsen Laboratories, Gilroy, CA
Method of Animal Distribution: Animals weight-randomized into groups by sex, assigned to cages, and cages assigned to dose groups.
Diet: NIH 07; available ad libitum
Size of Study Groups: 10 males and 10 females of each species. Rats were housed 5 per cage, and mice were individually caged.
Time Held Before Study: Rats 14 d, mice 15 d
Age When Placed on Study: 6 wk
Type and Frequency of Observation: Observed 2 X d, weighed initially and 1 x wk thereafter.
Age When Killed: 19 wk
Animal Room Environment:
Temperature: 68-76°F;
Relative humidity: 42-72%;
Fluorescent light 12 h/d;
Air-changes: 10 room air changes/h

Administration / exposure

Route of administration:
oral: feed
Details on analytical verification of doses or concentrations:
The stability of the study material during the toxicology studies was monitored by determination of peroxide content and by high performance liquid chromatography. The homogeneity of castor oil in feed at 10% (100 mg/g) was determined by gravimetric analysis, and blends at 0.5% (5 mg/g) were determined by HPLC analysis. Periodic analysis of the castor oil-formulated diets was conducted by HPLC at the study and analytical chemistry laboratories. Three complete sets of formulated diet mixtures were analyzed by either the study laboratory or the analytical laboratory during the 13-week studies.
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
Daily
Details on study schedule:
Sperm motility and morphology were evaluated at necropsy, and vaginal cytology was evaluated on core-study animals during the week just preceding necropsy. Females were subject to vaginal lavage with saline 12 days prior to termination. Sperm motility was evaluated at necropsy. After sperm sampling for motility evaluation, the cauda was placed in phosphate buffered saline (PBS), and gently chopped with a razor blade. The solution was mixed gently and heat-fixed at 65°C. Sperm density was then determined using a hemocytometer. The left testis was frozen and stored for counting of homogenization spermatid nuclei at a later date.
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 0.62, 1.25, 2.5, 5.0, and 10.0% in feed
Basis:
nominal in diet
No. of animals per sex per dose:
10
Control animals:
yes, plain diet

Examinations

Parental animals: Observations and examinations:
Observed twice per day, weighed initially and once per week thereafter.
Oestrous cyclicity (parental animals):
The aspirated cells gained from the vaginal lavage were air-dried onto slides, stained with Toluidine Blue O, and coverslipped. The relative preponderance of leukocytes, nucleated epithelial cells, and large squamous epithelial cells were used to identify the stages of the estrual cycle.
Sperm parameters (parental animals):
The left epididymis was removed and quickly weighed; the cauda epididymis was removed at the junction of the vas deferens and the corpus epididymis, then weighed. A small cut was made in the distal cauda epididymis. The sperm removed from the epididymis were dispersed and the number of moving and non-moving sperm were counted in 5 fields of 30 sperm or less on each slide. After thawing of the left testis, testicular spermatid head count was determined by removing the tunica albuginea and homogenizing the testis in PBS containing 10% DMSO. Homogenization spermatid nuclei were enumerated using a hemocytometer; the data were expressed as spermatid heads per total testis and per gram of testis.
Litter observations:
Not included.
Postmortem examinations (parental animals):
Necropsy and Histologic Examinations:
The following tissues were routinely processed for preparation of histologic sections and microscopic examination: adrenal glands, brain, cecum, colon, duodenum, epididymis/seminal vesicles/prostate/testes or ovaries/uterus, esophagus, eyes (if grossly abnormal), femur (including marrow), heart, ileum, jejunum, kidneys, liver, lungs and mainstem bronchi, mammary gland, mandibular and mesenteric lymph nodes, nasal cavity and turbinates, pancreas, parathyroid glands, pituitary gland, preputial or clitoral glands, rectum, salivary glands, skin, spinal cord and sciatic nerve (if neurologic signs present), spleen, forestomach and glandular stomach, thymus, thyroid gland, trachea, urinary bladder, zymbal glands, and all gross lesions and tissue masses including regional lymph nodes.
A complete histopathologic examination was conducted on all rats and mice from the control and 10% dose groups. Liver was examined from male rats in all other dose groups, and histologic sections of gross lesions were examined from all rats.
Postmortem examinations (offspring):
Not included.
Statistics:
Not applcable fro the reproductive parameters.
Reproductive indices:
Sperm mobility and quantity.
Staging of the estrual cycle.
Offspring viability indices:
Not included.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects 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:
not examined

Details on results (P0)

No significant adverse effects of castor oil administration were noted in these studies.

Effect levels (P0)

open allclose all
Dose descriptor:
NOAEL
Effect level:
5 800 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Remarks on result:
other: Generation: young sexually mature rats (migrated information)
Dose descriptor:
NOAEL
Effect level:
5 725 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Remarks on result:
other: Generation: young sexually mature rats (migrated information)
Dose descriptor:
NOAEL
Effect level:
15 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male
Remarks on result:
other: Generation: adolescent to adult mice (migrated information)
Dose descriptor:
NOAEL
Effect level:
16 800 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Remarks on result:
other: Generation: adolescent to adult mice (migrated information)

Results: F1 generation

General toxicity (F1)

Clinical signs:
not examined
Mortality / viability:
not examined
Body weight and weight changes:
not examined
Sexual maturation:
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
not examined
Histopathological findings:
not examined

Details on results (F1)

Not included in the study.

Overall reproductive toxicity

Reproductive effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
No significant changes were noted in a screening for male reproductive endpoints, including sperm count and motility, and no changes were observed in the length of estrous cycles of rats or mice given diets containing castor oil. Thus, no significant adverse effects of castor oil administration were noted in these studies.