Reaction products resulting from the esterification of Sorbitol with C8 – 18 (even) and C18 unsaturated fatty acids in the ratio of 1:1

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment (test substance was applied for only 14 days but twice daily, test substance volume unclear).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Principles of method if other than guideline:

Repeated application (twice daily) of the test substance to mice.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Sorbitan laurate

EC Number:

215-663-3

EC Name:

Sorbitan laurate

Cas Number:

1338-39-2

Molecular formula:

C18H34O6

IUPAC Name:

1,4-anhydro-6-O-dodecanoyl-D-glucitol

Constituent 2

Reference substance name:

Reaction products resulting from the esterification of Sorbitol with C8 – 18 (even) and C18 unsaturated fatty acids in the ratio of 1:1

EC Number:

931-434-7

Cas Number:

1338-39-2

Molecular formula:

Molecular formula cannot be given as substance is a mixture.

IUPAC Name:

Reaction products resulting from the esterification of Sorbitol with C8 – 18 (even) and C18 unsaturated fatty acids in the ratio of 1:1

Details on test material:

- Name of test material (as cited in study report): Dehymuls SML, Sorbitanmonolaurat
- Physical state: clear yellow liquid
- Analytical purity: 100%
- Lot/batch No.: LOT 202
- Other information: soluble in mineral oil, dispersible in water

Note: Due to analytical test results the substance is defined as UVCB. For further details see IUCLID Chapter 1.2.

Test animals

Species:

mouse

Strain:

other: HRS hr/hr

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: adult, not further specified

Administration / exposure

Type of coverage:

open

Vehicle:

water

Details on exposure:

TEST SITE
- Area of exposure: back skin, not further specified

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 drops
- Concentration (if solution): 10 and 50%
- Constant volume or concentration used: no

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

14 days

Frequency of treatment:

twice daily for 5 days per week

Doses / concentrations

Remarks:

Doses / Concentrations:
10 and 50%
Basis:
no data

No. of animals per sex per dose:

5

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:

not specified

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

Organ weight findings including organ / body weight ratios:

not specified

Gross pathological findings:

not specified

Histopathological findings: non-neoplastic:

not specified

Histopathological findings: neoplastic:

not specified

Effect levels

Dose descriptor:

NOAEL

Effect level:

50 other: %

Based on:

test mat.

Sex:

female

Basis for effect level:

other: No effects were observed after a repeated application of the test substance as 50% solution (twice daily for 14 days) to the skin of mice.

Target system / organ toxicity

Critical effects observed:

not specified