Propanoic acid, 2-hydroxy-, C12-15-alkyl esters

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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.

Justification for type of information:

The study is performed before in-vitro testing was preferably applied.

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-, C12-15-alkyl esters

EC Number:

300-338-1

EC Name:

Propanoic acid, 2-hydroxy-, C12-15-alkyl esters

Cas Number:

93925-36-1

Molecular formula:

C3O2-C12/13/14/15

IUPAC Name:

Propanoic acid, 2-hydroxy-, C12-15-alkyl esters

Constituent 2

Reference substance name:

Ceraphyl 41

IUPAC Name:

Ceraphyl 41

Test material form:

other: liquid

Details on test material:

Batch #5710

Test animals

Species:

rabbit

Strain:

other: normal albino

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:

4

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 - <= 1

Max. score:

4

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:

3

Max. score:

8

Reversibility:

other: Not reversible at 72h for abraded skin

Remarks on result:

probability of weak irritation

Results 4

Irritation parameter:

edema score

Basis:

other: total score

Time point:

other: 72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 h

Score:

0.5

Remarks on result:

other: primary irritation index was not correctly performed in the report

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 0.5 it can be considered as a very mildly primary irritant and not sufficient for classification.

Executive summary:

CERAPHYL® 41 was moderately irritating to rabbit skin. Three albino rabbits each received a single dermal application of CERAPHYL® 41 (0.5 ml) on one intact and abraded site per rabbit for 24 hours under occlusion. Dermal reactions were scored at 24 and 72 hours after unwrapping. Moderate erythema was observed at 24 hours on intact skin and at 24 and 72 hours on abraded skin. No edema was observed at any time. The primary irritation index was 0.5.