Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-12-05 to 2009-02-27
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 (1 male and 2 females)
Details on study design:
TEST SITE
- Area of exposure: approximately 100 cm² (10 cm x 10 cm)
- Type of wrap if used: The dressing was wrapped around the abdomen and anchored with tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the exposure, the dressing was removed and the skin was flushed with lukewarm tap water to clean the application site.


SCORING SYSTEM:
Data are summarized in tabular form, showing the irritation scores according to Commission Regulation (EC) No 440/2008 of 30 May 2008 for erythema and oedema for each individual animal at all observation intervals after patch removal, any lesions, a description of the degree and nature of irritation, corrosion or reversibility, and any other toxic effects observed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24hours
Score:
ca. 0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hours
Score:
ca. 0.67
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
ca. 1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
ca. 0
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
No staining produced by the test item of the treated skin was observed. No alterations of the treated skin were observed and no corrosive effects were evident on the skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Sorbitan caprylate is considered to be “not irritating” to rabbit skin.
Executive summary:

The primary skin irritation potential of sorbitan caprylate was investigated according to OECD test guideline no. 404. The test item was applied by topical semi-occlusive application of 0.5 mL to the intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours as well as 7 days after removal of the dressing.

The mean score was calculated across 3 scoring times (24, 48 and 72 hours after patch removal) for each animal for erythema/eschar grades and for oedema grades, separately. The mean erythema/eschar score of the three animals was 0.00, 0.67 and 1.00, respectively, and the mean oedema score was 0.00 for all animals.

The application of sorbitan caprylate to the skin resulted in mild signs of irritation (erythema). These effects were reversible and were no longer evident 7 days after treatment, the end of the observation period for all animals. The test item caused no staining of the treated skin. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals and no clinical signs were observed.

Thus, the test item did not induce significant or irreversible damage to the skin. sorbitan caprylate is considered to be “not irritating” to rabbit skin.