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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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:
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:
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
Reference substance name:
Ceraphyl 50
IUPAC Name:
Ceraphyl 50
Test material form:
other: liquid
Details on test material:
Batch #41-48-1/8-27-71
10% Ceraphyl 50

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:
other: 24
Score:
0
Max. score:
0
Remarks on result:
other: For both intact and abraded skin.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Remarks on result:
other: For both intact and abraded skin.
Irritation parameter:
erythema score
Basis:
other: total
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
edema score
Basis:
other: total score
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
no data
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 h
Score:
0
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.