Jojoba, ext., hydrogenated

Toxicity to reproduction

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

Test material information

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 / concentrations

Doses / concentrations 1

Dose / conc.:

250 mg/kg bw/day (nominal)

Doses / concentrations 2

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.