Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Product Ceraphyl®31

Test animals

Species:
rabbit
Strain:
other: normal albino
Details on test animals 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.