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Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
1. CATEGORY HYPOTHESIS
The hypothesis is that substances derived from the desert shrub Simmondsia chinensis seed present the same pattern of toxicological effects.

2. CATEGORY JUSTIFICATION
The category is justified based on chemical similarities between Simmondsia Chinensis (Jojoba) Seed derived substances and similar patterns of toxicological profil as summarized by the Cosmetic Ingredient Review Expert Panel:
Simmondsia Chinensis (Jojoba) Seed Oil was reported to readily penetrate nude mouse skin and to increase penetration of other agents such as aminophylline in clinical tests. Simmondsia Chinensis (Jojoba) Seed Oil was not an acute oral toxicant to mice or rats (LD50 generally greater than 5.0 g/kg). Short-term subcutaneous administration of Simmondsia Chinensis (Jojoba) Seed Wax to rats at 1 ml/kg was not toxic. Neither the wax nor the oil were toxic when applied dermally to the shaved backs of guinea pigs in short-term tests. A dermal irritation test found aqueous Hydrolyzed Jojoba Esters (20%) to be non-irritating to guinea pigs. Jojoba Alcohol was found to be nonirritating to the skin of albino marmots at 10.0%. Simmondisa Chinensis (Jojoba) Butter was classified as a non-irritant when applied to the intact and abraded skin of New Zealand white rabbits at 0.5 ml for 24 h under an occluded patch. Jojoba Alcohol at concentrations up to 50% was minimally irritating in rabbits. Simmondsia Chinensis (Jojoba) Seed Oil was non- to slightly irritating when instilled into the eyes of white rabbits, but Simmondsia Chinensis (Jojoba) Seed Wax, Jojoba Esters, and Jojoba Alcohol were not. Simmondsia Chinensis (Jojoba) Seed Wax was moderately comedogenic in tests using rabbits, but Jojoba Esters was noncomedogenic, and Jojoba Esters were non- to slightly- comedogenic. Simmondsia Chinensis (Jojoba) Butter, Jojoba Alcohol, and Jojoba Esters were non-mutagenic in Ames testing.

3. APPLICABILITY DOMAIN OF THE CATEGORY
The category is applicable to toxicological assessment, as based on the conclusions of the Cosmetic Ingredient Review Expert Panel that the substances included in the category were considered of safe use as cosmetics ingredients.

Data source

Reference
Reference Type:
review article or handbook
Title:
Safety Assessment of Simmondsia Chinensis (Jojoba) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Wax, Hydrogenated Jojoba Oil, Hydrolyzed Jojoba Esters, Isomerized Jojoba Oil, Jojoba Esters...
Author:
Cosmetic Ingredient Review Expert Panel
Year:
2008
Bibliographic source:
Cosmetic Ingredient Review

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Verschuren (1989) fed Simmondsia Chinensis (Jojoba) Seed Oil to male and female SPF Wistar rats (6 weeks old at acclimation) for 4 weeks. The rats were fed a purified diet with Simmondsia Chinensis (Jojoba) Seed Oil at 0 (n = 12), 2.2% (n = 10), 4.5% (n = 10), and 9% (n = 12). After 6 d on the diet, 2 of each sex in the control and high dose groups were killed and the hearts examined for fat deposition. After 3 weeks on the diet, blood was collected and analyzed. After 4 weeks on the diet, the feces were sampled and analyzed for lipid content. At the end of the experiment, the rats were killed and necropsied, blood collected and analyzed, and tissues were histologically examined.
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Jojoba, ext., hydrogenated
EC Number:
296-292-4
EC Name:
Jojoba, ext., hydrogenated
Cas Number:
92457-12-0
Molecular formula:
No molecular formula is available since it is a UVCB substance
IUPAC Name:
Jojoba (Simmondsia Chinensis) Seed Oil Hydrogenated

Administration / exposure

Route of administration:
oral: gavage
Analytical verification of doses or concentrations:
not specified

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
All the rats appeared to be in good health and no clinical signs were observed.
Mortality:
no mortality observed
Description (incidence):
No deaths occurred during the experiment.
Body weight and weight changes:
effects observed, treatment-related
Description (incidence and severity):
There was a dose-dependent growth retardation in both sexes.
Food consumption and compound intake (if feeding study):
no effects observed
Description (incidence and severity):
Feed intake and water consumption did not differ between the groups.
The amount of feces produced increased with Simmondsia Chinensis (Jojoba) Seed Oil intake.
The lipid content of the feces had a dose-dependent increase (up to > 6-fold).
Water consumption and compound intake (if drinking water study):
no effects observed
Ophthalmological findings:
not examined
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
There were no hematological differences except for the white blood cell count which increased in the high dose group in both males (13.6 ± 0.67 vs 16.9 ± 1.02) and females (13.7 ± 0.90 vs 21.0 ± 2.03).
Clinical biochemistry findings:
effects observed, treatment-related
Description (incidence and severity):
Serum analysis showed an increase enzyme activities (isocitrate dehydrogenase [ICDH], saccharopine, dehydrogenase [SDH], alkaline phosphatase [ALP], aspartate aminotransferase [AST], alanine aminotransferase [ALT], hydroxybutyrate dehydrogenase [α-HBDH], and creatine kinase [CK]).
Urinalysis findings:
effects observed, treatment-related
Description (incidence and severity):
Urea concentrations increased in a dose dependent manner. A negative correlation was found for creatine and triacylglycerols and dose levels.
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
Animals fed Simmondsia Chinensis (Jojoba) Seed Oil had less body fat deposition. Absolute weights of the organs decreased for both sexes except for the spleen in the females. There was no evident adverse effect to the heart after 6 d of the Simmondsia Chinensis (Jojoba) Seed Oil diet. The stomachs of the rats fed Simmondsia Chinensis (Jojoba) Seed Oil were much fuller compared to the controls. The small intestines were distended and the contents were more fluid and non-homogenous compared to controls. The contents of the cecum were coarse and heterogenous compared to controls. The jejunum and ileum of the treatment
groups were characterized by massive vacuolization of the enterocytes, distension of the lamina propria, and an increase in cellular components. There was increased cell turnover in the crypts of Lieberkuhn.
Details on results:
Simmondsia Chinensis (Jojoba) Seed Oil
The oral toxicity of refined Simmondsia Chinensis (Jojoba) Seed Oil was evaluated using 4 groups of 10 male Sprague-Dawley rats (avg. weight 80.6 g). Two of the groups were fed basal diets (5 g/feeding) containing 0.5 or 1.0 g of Simmondsia Chinensis (Jojoba) Seed Oil once daily for 7 days. The remaining 2 groups were fed basal diets containing 2.0 or 3.0 g of Simmondsia Chinensis (Jojoba) Seed Oil once daily for 4 d. The animals were given water ad libitum. Signs of toxicity were observed in 5 of the rats that were fed 1.0 g of Simmondsia Chinensis (Jojoba) Seed Oil (in diet) and all of the rats fed 2.0 and 3.0 g of Simmondsia Chinensis (Jojoba) Seed Oil. The mortality rate was 10% in each of these 3 groups. None of the rats fed 0.5 g of Jojoba Oil died (Hamm 1984).

Verschuren (1989) fed Simmondsia Chinensis (Jojoba) Seed Oil to male and female SPF Wistar rats (6 weeks old at acclimation) for 4 weeks. The rats were fed a purified diet with Simmondsia Chinensis (Jojoba) Seed Oil at 0 (n = 12), 2.2% (n = 10), 4.5% (n = 10), and 9% (n = 12). After 6 d on the diet, 2 of each sex in the
control and high dose groups were killed and the hearts examined for fat deposition. After 3 weeks on the diet, blood was collected and analyzed. After 4 weeks on the diet, the feces were sampled and analyzed for lipid content. At the end of the experiment, the rats were killed and necropsied, blood collected and analyzed, and tissues were histologically examined.
No deaths occurred during the experiment. All the rats appeared to be in good health and no clinical signs were observed. There was a dose-dependent growth retardation in both sexes. Feed intake and water consumption did not differ between the groups. The amount of feces produced increased with Simmondsia
Chinensis (Jojoba) Seed Oil intake. The lipid content of the feces had a dose-dependent increase (up to > 6-fold). There were no hematological differences except for the white blood cell count which increased in the high dose group in both males (13.6 ± 0.67 vs 16.9 ± 1.02) and females (13.7 ± 0.90 vs 21.0 ± 2.03). Serum
analysis showed an increase enzyme activities (isocitrate dehydrogenase [ICDH], saccharopine dehydrogenase [SDH], alkaline phosphatase [ALP], aspartate aminotransferase [AST], alanine aminotransferase [ALT], hydroxybutyrate dehydrogenase [α-HBDH], and creatine kinase [CK]). Urea concentrations increased in a dose dependent manner. A negative correlation was found for creatine and triacylglycerols and dose levels.

Animals fed Simmondsia Chinensis (Jojoba) Seed Oil had less body fat deposition. Absolute weights of the organs decreased for both sexes except for the spleen in the females. There was no evident adverse effect to the heart after 6 d of the Simmondsia Chinensis (Jojoba) Seed Oil diet. The stomachs of the rats fed Simmondsia Chinensis (Jojoba) Seed Oil were much fuller compared to the controls. The small intestines were distended and the contents were more fluid and non-homogenous compared to controls. The contents of the cecum were coarse and heterogenous compared to controls. The jejunum and ileum of the treatment
groups were characterized by massive vacuolization of the enterocytes, distension of the lamina propria, and an increase in cellular components. There was increased cell turnover in the crypts of Lieberkuhn.

In a second experiment, 2 groups of rats (n = 5) were fed the diet with either 0 or 9% Simmondsia Chinensis (Jojoba) Seed Oil. After 3 weeks, the rats were killed and the small intestine removed and examined. The entire small intestine was affected except the anterior section of the duodenum and the posterior section of the
ileum. There was an accumulation of fat in the vacuoles of the enterocytes in the upper region of the villi. The ALP activity was decreased. In the livers, there was a slight increase in intracellular acidophilic vacuoles, acidophilic bodies, and the number of mitoses (Verschuren 1989).

Effect levels

open allclose all
Dose descriptor:
conc. level:
Effect level:
ca. 2.2 other: %
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical biochemistry
Remarks on result:
other: The results is expressed in %
Key result
Dose descriptor:
NOAEL
Effect level:
>= 9 other: %
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
food consumption and compound intake
gross pathology
haematology
mortality
Remarks on result:
other: The results is expressed in %

Target system / organ toxicity

open allclose all
Critical effects observed:
no
Key result
Critical effects observed:
no

Applicant's summary and conclusion

Conclusions:
Simmondisa Chinensis (Jojoba) Seed Oil administered in the diet of rats resulted in 10% mortality in all 3 exposures (1.0, 2.0, and 3.0 g/d). Simmondsia Chinensis (Jojoba) Seed Oil fed to rats reduced food consumption but did not affect food transit time.
When rats in another study were fed up to 9% Simmondisa Chinensis (Jojoba) Seed Oil in their diet for up to 4 weeks, there were no deaths and no clinical signs. Lipid content in the feces and urea concentration increased dose-dependently. White blood cell counts increased in the high dose group.