Sorbitan palmitate

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Only secondary literature (no data on test substance purity, limited documentation, tested product only contained 4% test substance)

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, Vol4, 3, 1985, p 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:

1979

Report date:

1979

Materials and methods

Principles of method if other than guideline:

28-days dermal toxicty study, where 4 male and 4 female rabbits received an application of 0.3 and 0.9 mL/kg per 75 cm² body surface area, respectively, of a product containing 4% test substance.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

26266-57-9 [purity: 4%]

IUPAC Name:

26266-57-9 [purity: 4%]

Details on test material:

- Analytical purity: no data, but the product was assumed to contain 4% of the test substance

Test animals

Species:

rabbit

Strain:

other: Albino

Sex:

male/female

Administration / exposure

Details on exposure:

TEST SITE
- Area of exposure: 75 cm² on the back
- Preparation of test site: shaved (all), abraded (2 animals)

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.3 and 0.9 mL/kg per 75 cm² body surface area
- Concentration (if solution): 4% in technical product

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

4 weeks

Frequency of treatment:

daily, 5 days/week

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0.3, 0.9 mL product/kg bw/day
Basis:
nominal per unit body weight

Doses / concentrations 2

Remarks:

Doses / Concentrations:
0.012, 0.036 mL/kg bw/day
Basis:
other: based on the information that the product contains 4% of the test substance

Doses / concentrations 3

Remarks:

Doses / Concentrations:
13, 39.24 mg/kg bw/day
Basis:
other: calculated on a density of 1.09 g/cm³ (see chapter 4.4)

No. of animals per sex per dose:

4

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
- Time schedule for examinations: weekly

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

HAEMATOLOGY: Yes

URINALYSIS: Yes

Sacrifice and pathology:

GROSS PATHOLOGY: Yes, animals were necropsied 2 days after the last application
- Organ weights of liver, kidney, heart, spleen, thyroid, adrenals, testes, ovaries were taken and body to organ weight ratios were performed
HISTOPATHOLOGY: Yes
- Examinations of liver, kidney, heart, spleen, thyroid, adrenals, testes, ovaries, thymus, urinary bladder, stomach, duodenum, jejenum, ileum, colon, straited muscles, treated skin

Results and discussion

Results of examinations

Clinical signs:

effects observed, treatment-related

Description (incidence and severity):

one control and one animal of the low-dose group became anorectic but recovered within a week; no deaths occured

Dermal irritation:

effects observed, treatment-related

Description (incidence and severity):

edema and erythema developed in animals of both dose groups with more severe effects in the animals of the high dose group

Mortality:

mortality observed, treatment-related

Description (incidence):

one control and one animal of the low-dose group became anorectic but recovered within a week; no deaths occured

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

not specified

Water consumption and compound intake (if drinking water study):

not specified

Ophthalmological findings:

not specified

Haematological findings:

no effects observed

Clinical biochemistry findings:

not specified

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not specified

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Details on results:

CLINICAL SIGNS AND MORTALITY
No mortality was noted during the study. One control and one low-dose animal became anorectic but recovered within a week. Animals treated with 0.3 mL/kg bw developed mild to moderate skin erythema during the first 2 weeks of treatment. Mild to moderate edema and scaly desquamation developed during the second week. Two animals had severe erythema during the last week of treatment. Similar but more severe dermatitis developed in the high-dose group.

Effect levels

Dose descriptor:

NOEL

Effect level:

39.24 mg/kg bw/day (nominal)

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