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Toxicological information

Skin irritation / corrosion

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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

Constituent 1
Chemical structure
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
Chemical structure
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
Chemical structure
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
Chemical structure
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

Resultsopen allclose all
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.
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.
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
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
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.

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