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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
read-across based on grouping of substances (category approach)
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.
Justification for type of information:
See section 13 for justification of read across.

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
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Batch #5710

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:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72
Score:
>= 0 - <= 1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: Intact skin: 0; abraded skin: 1
Irritation parameter:
erythema score
Basis:
other: total
Time point:
other: 72 h
Score:
3
Max. score:
4
Reversibility:
other: Not reversible at 72h for abraded skin
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
other: total score
Time point:
other: 72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of weak irritation
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 0.5 it can be considered as a very mildly primary irritant and not sufficient for classification.
Executive summary:

CERAPHYL® 41 was moderately irritating to rabbit skin. Three albino rabbits each received a single dermal application of CERAPHYL® 41 (0.5 ml) on one intact and abraded site per rabbit for 24 hours under occlusion. Dermal reactions were scored at 24 and 72 hours after unwrapping. Moderate erythema was observed at 24 hours on intact skin and at 24 and 72 hours on abraded skin. No edema was observed at any time. The primary irritation index was 0.5.