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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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.
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
Irritation parameter:
erythema score
Basis:
other: total
Time point:
other: 72 h
Score:
2
Max. score:
2
Reversibility:
other: Reversible at 72h
Irritation parameter:
edema score
Basis:
other: total score
Time point:
other: 72 h
Score:
0
Max. score:
0
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.