Sorbitan stearate

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 standard methods (the elevated product contained only 2% test substance, analytical purity not specified, only 4-7 animals/group, limited documentation, limited parameters evaluated).

Data source

Reference

Reference 1

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:

1985

Bibliographic source:

Journal of the American College of Toxicology 4(3): 65-121

Reference 2

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:

2002

Bibliographic source:

International Journal of Toxicology 21(suppl. 1): 93-112

Reference 3

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Principles of method if other than guideline:

3 months dermal toxicity study, where 5 male and 5 female rabbits received a daily application of 6.6 and 11 mg/cm² per 8.4 % body surface area, respectively, of a cosmetic product containing 2% test substance.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

1338-41-6 [purity: 2%]

IUPAC Name:

1338-41-6 [purity: 2%]

Details on test material:

- Analytical purity: no data, but the product was assumed to contain 2% of the test substance

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Administration / exposure

Details on exposure:

TEST SITE
- Area of exposure: 8.4% body surface area
- Preparation of test site: clipped

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 6.6 and 11 mg product/cm² per 8.4 percent body surface area
- Concentration (if solution): 2% of test substance in a cosmetic product

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

3 month

Frequency of treatment:

daily, 7 days/week

Doses / concentrations

Remarks:

Doses / Concentrations:
6.6, 11 mg product/cm²/8.4% body surface area
Basis:
nominal per unit body weight

No. of animals per sex per dose:

treatment groups: 4
control: 7

Control animals:

yes, concurrent no treatment

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes

DERMAL IRRITATION (if dermal study): Yes

BODY WEIGHT: Yes

FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes

HAEMATOLOGY: Yes

CLINICAL CHEMISTRY: Yes

URINALYSIS: Yes

Sacrifice and pathology:

GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes

Results and discussion

Results of examinations

Clinical signs:

effects observed, treatment-related

Description (incidence and severity):

one male and one female animal of the control group died of septicemia

Dermal irritation:

effects observed, treatment-related

Description (incidence and severity):

slight edema, moderate erythema and desquamation developed in animals of both dose groups

Mortality:

mortality observed, treatment-related

Description (incidence):

one male and one female animal of the control group died of septicemia

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

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:

not examined

Histopathological findings: neoplastic:

not examined

Details on results:

CLINICAL SIGNS AND MORTALITY
One male and one female animal of the control group died of septicemia. Well-defined, moderate erythema, slight edema, and slight desquamation were observed, and inflammatory changes were present at the application sites of treated animals.

BODY WEIGHT
No substance-related effects noted.

FOOD CONSUMPTION
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
No substance-related effects noted.

GROSS PATHOLOGY
No substance-related effects noted.

HISTOPATHOLOGY
No substance-related effects noted.

Effect levels

Dose descriptor:

NOEL

Effect level:

11 other: mg product/cm²/8.4% body surface area

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: No systemic effects were noted.

Target system / organ toxicity

Critical effects observed:

not specified