Zinc bis[12-hydroxyoctadecanoate]

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:

key study

Study period:

1992-10-20 to 1992-10-29

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 1981-05-12

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Octanoic acid, zinc salt, basic

EC Number:

291-793-4

EC Name:

Octanoic acid, zinc salt, basic

Cas Number:

90480-58-3

Test material form:

other: solid

Test animals

Species:

rabbit

Strain:

other: Kleinrussen, CHbb:HM

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Thomae GmbH, Biberach/D.
- Age at study initiation: approx. 9 months
- Weight at study initiation: approx. 2590 g
- Housing: individual accommodation in cages
- Diet (ad libitum): Ssniff rabbit diet K4 (Ssniff GmbH, Soest/D, Batch: 770992/09)
- Water (ad libitum): tap water
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: approx. 20-25 °C
- Relative humidity: approx. 45-70 %
- Air changes: at least eight per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): the undiluted test substance Stabiol VZN 1950 was applied at the dose level of 0.5 g per animal.

Duration of treatment / exposure:

4 hours

Observation period:

1, 24, 48 and 72 hours after exposure

Number of animals:

3 male rabbits

Details on study design:

TEST SITE
- Area of exposure: the flank of each experimental animal was sheared approx. 24 hours prior to the application with an electric clipper. Animals with intact and healthy skin were used in the test.
The semi-occlusive exposure was performed by means of a 6 cm^2 adhesive air- and vapour permeable gauze-patch which was fixed by a hypoallergic adhesive gauze-bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the exposure was terminated after four hours by removing the patch and cleaning the relevant skin from the residual test substance.

SCORING SYSTEM: according to Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

other: mean 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

No dermal effects were observed at all experimental animals up to 72 hours after exposure.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Octanoic acid, zinc salt, basic is not irritating to the skin.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as skin irritant.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as skin irritant.