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EC number: 232-360-1 | CAS number: 8007-43-0
Toxicological information
Repeated dose toxicity: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Does not meet important criteria of todays stadard methods (test material part of a mixture (containing only 1% test substance), analytical purity of test substance not provided, only 9 female animals/test group, limited documentation).
Data source
Referenceopen allclose all
- Reference Type:
- secondary source
- Title:
- Final Report on the Safety Assessment of Sorbitan Stearate, Sorbitan Laurate, Sorbitan Sesquioleate, Sorbitan Oleate, Sorbitan Tristearate, Sorbitan Palmitate, and Sorbitan Triolate
- Author:
- Elder, R.L., ed.
- Year:
- 1 985
- Bibliographic source:
- Journal of the American College of Toxicology 4(3): 465-121
- Reference Type:
- secondary source
- Title:
- Final Report on the Safety Assessment of Sorbitan Caprylate, Sorbitan Cocoate, Sorbitan Diisostearate, Sorbitan Dioleate, Sorbitan Distearate, Sorbitan Isostearate, Sorbitan Olivate, Sorbitan Sesquiisostearate, Sorbitan Sesquistearate, and Sorbitan Tri...
- Author:
- Lanigan RS, Yamarik TA; Cosmetic Ingredient Review Expert Panel
- Year:
- 2 002
- Bibliographic source:
- International Journal of Toxicology 21(suppl. 1): 93-112
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
- Principles of method if other than guideline:
- 13 weeks dermal toxicity study, where 9 female rabbits received an application of 0.3, 3, and 30 mg/kg bw respectively, of a hormone cream containing 2% test substance. An additional group was treated with 30 mg/kg of the same cosmetic without hormone.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 8007-43-0 [purity: 1%]
- IUPAC Name:
- 8007-43-0 [purity: 1%]
- Details on test material:
- - Analytical purity: no data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- female
Administration / exposure
- Details on exposure:
- TEST SITE
- Area of exposure: back
- Preparation of test site: clipped
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30, 300, and 3000 mg/kg bw
- Concentration (if solution): 1% in technical product - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily, 5 days/week, for a total of 65 treatments
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
30, 300, 3000 mg product/kg bw/day
Basis:
nominal per unit body weight
- Remarks:
- Doses / Concentrations:
0.3, 3, 30 mg/kg bw/day (the product contained 1% of the test substance)
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 9 females
- Control animals:
- yes, concurrent no treatment
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DERMAL IRRITATION (if dermal study): Yes
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
HAEMATOLOGY: Yes
CLINICAL CHEMISTRY: Yes
- Time schedule: before the first application and then at weeks 4, 7 and 13
URINALYSIS: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
- Organ weights of brain, heart, liver, kidney, spleen, adrenals were taken.
HISTOPATHOLOGY: Yes
- Examinations of brain, liver, kidney, heart, spleen, lung, pancreas, adrenals, spleen, ovaries, uterus, stomach, large and small intestine, bone marrow, skin
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- one animal died and two were killed due to non-product-related diseases (group membership not given)
- Dermal irritation:
- effects observed, treatment-related
- Description (incidence and severity):
- minimal to slight skin irritation in all dose groups
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- one animal died and two were killed due to non-product-related diseases (group membership not given)
- Body weight and weight changes:
- no effects observed
- 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:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
One animal died and two were killed due to non-product-related diseases (group membership not given). The skin from the application sites had no irritation in the untreated group, minimal irritation (slight irritation or slight desquamation) in the low dose group, minimal or negligible irritation in the mid dose group, slight irritation beginning in the fifth test week in the high dose group, and slight irritation beginning in the fourth test week in the high dose group without the hormone.
BODY WEIGHT
No substance-related effects noted.
HAEMATOLOGY
No substance-related effects noted.
CLINICAL CHEMISTRY
No substance-related effects noted.
URINALYSIS
No substance-related effects noted.
ORGAN WEIGHTS
A dose-related increase in uterine weight was observed of rabbits topically exposed to 0.3, 3, and 30 mg/kg bw/day of the product and also in splenic weight in animals receiving 3 and 30 mg/kg bw. Liver weights were decreased in animals given 3 and 30 mg/kg bw. It was assumed that the effect on organ weights was caused by the estrogenic hormone rather than the by the test substance.
GROSS PATHOLOGY
No substance-related effects noted.
HISTOPATHOLOGY
No substance-related effects noted.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No systemic effects were noted.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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