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Diss Factsheets

Administrative data

Endpoint:
repeated dose toxicity: dermal, other
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:
The subchronic dermal toxicity of refined Simmondsia Chinensis (Jojoba) Seed Wax was evaluated using 32 DH guinea pigs (320 ± 25 g). The animals were divided into 4 groups (4 males, 4 females/group). In the first 2 groups, Simmondsia Chinensis (Jojoba) Seed Wax was applied to shaved dorsal skin in doses of 0.25 and 0.5 g/kg, respectively. Applications were made 6 days per week for a total of 20 weeks. The application sites were not covered. The 2 control groups received applications of olive oil (0.5 g/kg) and saline, respectively, according to the same procedure.
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Reference substance name:
no defined IUPAC name
EC Number:
612-381-6
Cas Number:
61789-91-1
Molecular formula:
no molecular structure defined
IUPAC Name:
no defined IUPAC name
Test material form:
liquid: viscous

Test animals

Species:
guinea pig
Sex:
male/female

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Analytical verification of doses or concentrations:
not specified
Frequency of treatment:
6 days per week for a total of 20 weeks
Doses / concentrationsopen allclose all
Dose / conc.:
250 mg/kg bw/day
Dose / conc.:
500 mg/kg bw/day
No. of animals per sex per dose:
4 males, 4 females/group

Examinations

Sacrifice and pathology:
At the end of the treatment period, the animals were killed and gross and microscopic examinations were performed.

Results and discussion

Results of examinations

Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Description (incidence and severity):
There were no differences in body weights or organ weights (liver, heart, kidneys, and testes) between the 4 groups of guinea pigs.
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
There were no differences in body weights or organ weights (liver, heart, kidneys, and testes) between the 4 groups of guinea pigs.
Gross pathological findings:
no effects observed
Description (incidence and severity):
Furthermore, lesions were not observed in tissues from the following organs (all groups): adrenal gland, thyroid gland, kidney, urinary bladder, spleen, liver, pancreas, heart, brain (2 sections), stomach, small and large intestine, and skin from treated and untreated areas.

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
>= 500 mg/kg bw/day
Based on:
test mat.
Basis for effect level:
body weight and weight gain
gross pathology
mortality
organ weights and organ / body weight ratios

Target system / organ toxicity

open allclose all
Key result
Critical effects observed:
no
System:
endocrine system
Organ:
adrenal glands
thyroid gland
Key result
Critical effects observed:
no
System:
hepatobiliary
Organ:
bladder
kidney
liver
pancreas
Critical effects observed:
no
System:
cardiovascular
Organ:
heart
Critical effects observed:
no
System:
central nervous system
Organ:
brain
Critical effects observed:
no
System:
gastrointestinal tract
Organ:
intestine
stomach
Key result
Critical effects observed:
no
System:
integumentary
Organ:
skin

Applicant's summary and conclusion

Conclusions:
Simmondsia Chinensis (Jojoba) Seed Wax was not toxic when applied to the shaved backs of guinea pigs 6 d/week for 20 weeks up to 0.5 g/kg.