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Toxicological information

Repeated dose toxicity: dermal

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Administrative data

Endpoint:
sub-chronic toxicity: dermal
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:
2008
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 411 (Subchronic Dermal Toxicity: 90-Day Study)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes

Test animals

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

Administration / exposure

Type of coverage:
open
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

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
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
Positive control:
yes with olive oil

Examinations

Observations and examinations performed and frequency:
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.
Sacrifice and pathology:
GROSS PATHOLOGY: No

HISTOPATHOLOGY: No

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
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:
not specified
Behaviour (functional findings):
not specified
Immunological findings:
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Neuropathological findings:
no effects observed
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Other effects:
no effects observed

Effect levels

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
organ weights and organ / body weight ratios
gross pathology
neuropathology

Target system / organ toxicity

Key result
Critical 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.