Reaction products of tetradecan-1-ol and L-(+)-lactic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

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:

Tetradecyl lactate

EC Number:

215-350-1

EC Name:

Tetradecyl lactate

Cas Number:

1323-03-1

Molecular formula:

C17H34O3

IUPAC Name:

tetradecyl 2-hydroxypropanoate

Constituent 2

Reference substance name:

Tetradecanol

EC Number:

204-000-3

EC Name:

Tetradecanol

Cas Number:

112-72-1

Molecular formula:

C14H30O

IUPAC Name:

tetradecan-1-ol

Constituent 3

Reference substance name:

Propanoic acid, 2-hydroxy-, tetradecyl ester with dimers

Molecular formula:

C20H38O5

IUPAC Name:

Propanoic acid, 2-hydroxy-, tetradecyl ester with dimers

Constituent 4

Reference substance name:

Propanoic acid, 2-hydroxy-, tetradecyl ester with trimers

Molecular formula:

C23H42O7

IUPAC Name:

Propanoic acid, 2-hydroxy-, tetradecyl ester with trimers

Test material form:

liquid

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:

24 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Remarks:

For both intact and abraded skin.

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

0

Remarks on result:

no indication of irritation

Remarks:

For both intact and abraded skin.

Results 3

Irritation parameter:

erythema score

Basis:

other: total

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

no data

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

other: total score

Time point:

72 h

Score:

0

Max. score:

0

Reversibility:

no data

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

72 h

Score:

0

Remarks on result:

no indication of irritation

Other effects:

Not specified.

Applicant's summary and conclusion

Interpretation of results:

not 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 it can be considered as non-irritant and not sufficient for classification.