Propanoic acid, 2-hydroxy, C12-C16 (even numbered) alkyl esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Remarks:

Result are from an in-vivo study performed in 1970, i.e. before the in vitro skin irritation requirement.

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1970

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The test is non-GLP but the parameters documented partially comply with a specific testing guideline.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Observations only after 24 and 72 h.

Principles of method if other than guideline:

The irritation index is based on the Draize method in this study. Presently, this method is no longer used for determination of the degree of irritation.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propanoic acid, 2-hydroxy, C12-C16 (even numbered) alkyl esters

Molecular formula:

C3O2-C12/14/16

IUPAC Name:

Propanoic acid, 2-hydroxy, C12-C16 (even numbered) alkyl esters

Specific details on test material used for the study:

Product Ceraphyl®31

Test animals

Species:

rabbit

Strain:

other: normal albino

Details on test animals or test system and environmental conditions:

Not specified.

Test system

Type of coverage:

occlusive

Preparation of test site:

other: Clipped with minor abrasions

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml

Duration of treatment / exposure:

24

Observation period:

At the end of the 24-hour period and 48 hours later. Scoring of irritation according to the method of Draize.

Number of animals:

3

Details on study design:

0.5 ml test substance applied on the scarified and 0.5 ml on non-scarified area, which were covered with Webril patches. Animals were immobilized in racks for the 24-hour period.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24

Score:

1

Max. score:

1

Remarks on result:

other: Intact and abraded skin: score 1 means very slight and barely perceptible.

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72

Score:

0

Max. score:

1

Remarks on result:

other: Intact skin: 0; abraded skin: 1

Results 3

Irritation parameter:

erythema score

Basis:

other: total

Time point:

other: 72 h

Score:

2

Max. score:

2

Reversibility:

other: Reversible at 72h

Results 4

Irritation parameter:

edema score

Basis:

other: total score

Time point:

other: 72 h

Score:

0

Max. score:

0

Results 5

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 h

Score:

0.3

Other effects:

Not specified.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: Scoring according to Draize

Conclusions:

Since the test material produced a primary irritation index of 0.3, it can be considered as a mild primary irritant and not sufficient for classification.