Registration Dossier

Toxicological information

Toxicity to reproduction

Currently viewing:

Administrative data

Endpoint:
screening for reproductive / developmental toxicity
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1982
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: OECD 411
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Simmondsia Chinensis (Jojoba) Seed Wax
Cas Number:
61789-91-1
Molecular formula:
C42 H84 O2
IUPAC Name:
Simmondsia Chinensis (Jojoba) Seed Wax
Test material form:
solid: flakes

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Details on species / strain selection:
32 GH guinea pigs (320 +- 25 g). the animal were divided into 4 groups (4 males, 4 females / group).
Sex:
male/female

Administration / exposure

Route of administration:
dermal
Vehicle:
unchanged (no vehicle)
Details on exposure:
TEST SITE
- Area of exposure: dorsal skin
- % coverage: not specified


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.25 and 0.5 g/kg
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
Applications were made 6 days par week for a total of 20 weeks (180 days)
Frequency of treatment:
Applications were made 6 days par week for a total of 20 weeks (180 days)
Doses / concentrationsopen allclose all
Dose / conc.:
250 mg/kg bw/day (nominal)
Dose / conc.:
500 mg/kg bw/day (nominal)
No. of animals per sex per dose:
1 group (4 males and 4 females) with 250 mg/kg bw and the same composition for the control group with olive oil
1 group (4 males and 4 females) with 500 mg/kg bw and the same composition for the control group with olive oil
Control animals:
yes

Examinations

Parental animals: Observations and examinations:
At the end of the treatment period, the animals were killed and gross and microcospic examinations were performed.
There were no differences in body weights or organ weights (liver, heart, kidneys, and testes) between the 4 groups of guinea pigs.
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.

Results and discussion

Results: P0 (first parental generation)

General toxicity (P0)

Clinical signs:
no effects observed
Dermal irritation (if dermal study):
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
no effects observed
Behaviour (functional findings):
no effects observed
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
no effects observed

Reproductive function / performance (P0)

Reproductive function: oestrous cycle:
not specified
Reproductive function: sperm measures:
no effects observed
Reproductive performance:
not specified

Effect levels (P0)

Key result
Dose descriptor:
NOAEL
Effect level:
>= 500 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
mortality
dermal irritation
body weight and weight gain
urinalysis
organ weights and organ / body weight ratios
gross pathology

Target system / organ toxicity (P0)

Key result
Critical effects observed:
no
Lowest effective dose / conc.:
500 mg/kg bw/day (nominal)
System:
male reproductive system
Organ:
abdominal cavity
adrenal glands
bladder
brain
heart
intestine
kidney
liver
pancreas
skin
spleen
testes
thyroid gland

Results: F1 generation

General toxicity (F1)

Clinical signs:
not examined
Dermal irritation (if dermal study):
not examined
Mortality / viability:
not examined
Body weight and weight changes:
not examined
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
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
Other effects:
not examined

Developmental neurotoxicity (F1)

Behaviour (functional findings):
not examined

Developmental immunotoxicity (F1)

Developmental immunotoxicity:
not examined

Effect levels (F1)

Key result
Dose descriptor:
NOAEL
Generation:
F1
Effect level:
>= 0 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Remarks on result:
other: not performed

Target system / organ toxicity (F1)

Key result
Critical effects observed:
not specified
Lowest effective dose / conc.:
0 mg/kg bw/day (nominal)

Overall reproductive toxicity

Key result
Reproductive effects observed:
no
Lowest effective dose / conc.:
500 mg/kg bw/day (nominal)

Applicant's summary and conclusion

Conclusions:
Simmondsia Chinensis (Jojoba) Wax is considered to be not harmful according to the subchronic dermal toxicity study.No effects were observed on the reproductive organ.