Dehydrated sorbitol, C18 (unsaturated) fatty acid esters, ethoxylated

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: Original report not available and documentation insufficient for assessment (analytical purity of test substance not specified, repeated treatment, 0.3 g application amount/treatment, scoring system not traceable).

Data source

Reference

Reference Type:

publication

Title:

Dermatitic Effect of Nonionic Surfactants I Gross, Microscopic, and Metabolic Changes in Rabbit Skin Treated with Nonionoc Surface-active Agents

Author:

Mezei, M. et al.

Year:

1966

Bibliographic source:

J Pharm Sci 55(6): 548-590

Materials and methods

Principles of method if other than guideline:

The test substance was applied daily to the clipped trunks of New Zealand White rabbits for a total of 81 days.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sorbitan monooleate, ethoxylated

EC Number:

500-019-9

EC Name:

Sorbitan monooleate, ethoxylated

Cas Number:

9005-65-6

Molecular formula:

Not applicable as UVCB

IUPAC Name:

Sorbitan, C18-unsat, fatty acid esters, ethoxylated (1 - 6.5 moles ethoxylated)

Constituent 2

Reference substance name:

Tween 80

IUPAC Name:

Tween 80

Details on test material:

- Name of test material (as cited in study report): polyoxyethylene (20) sorbitan monooleate (Polysorbate 80)
- Analytical purity: no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

open

Preparation of test site:

clipped

Vehicle:

other: water, hydrophilic ointment U.S.P. (H.O.)

Controls:

other: not required, untreated site and site treated with ointment base of the same animal served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.3 g
- Concentration (if solution): 100% (undiluted), 10% in water, 10% in H.O., 5% in water and 5% in H.O.

VEHICLE
- Amount(s) applied: not specified

Duration of treatment / exposure:

daily application without washing for a total of 81 days

Observation period:

up to 81 days
Reading time points: 3 and 10 days, 1 month

Number of animals:

50

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of the whole experiment (on the 81st day)

Results and discussion

In vivo

Irritant / corrosive response data:

After 3 days, slight erythema and edema were observed in all treatment groups, except for treatment with 5% of the test substance in water which resulted in no visible change on the skin. After 10 days, moderate erythema and edema were observed after treatment with the undiluted test substance and the test substance diluted at 10% in H.O., whereas only slight erythema and edema were found after application of the test substance at 10% in water and 5% in H.O., respectively. Consistent with the 3-day reading time point, no visible change on the skin was observed after treatment with 5% of the test substance in water.

Applicant's summary and conclusion

Interpretation of results:

other: inconclusive

Remarks:

Criteria used for interpretation of results: EU