Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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
Species:
rabbit
Strain:
other: normal albino
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.
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.
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Since the test material produced a primary irritation index for skin of 0 to 0.5, it can be considered as only a very slightly primary irritant and not sufficient for classification. A study with test material did not induce significant irritation of rabbits eye, implying no reason for classification as an eye irritant.