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Description of key information

Skin irritation/corrosion: Ullmann 1985. Primary Skin Irritation Rabbits, OECD404: no classification
Eye irritation: Suberg 1985. Eye irritation, OECD405: slightly irritating

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:
weight of evidence
Study period:
8 March 1985 to 3 April 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, publication/study report which meets basic scientific principles, but details missing
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
no data
Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
- Concentration: undiluted
Duration of treatment / exposure:
4 hrs
Observation period:
1, 24, 48 and 72 hours after removal of dressing
Number of animals:
6 (3 per sex)
Details on study design:
TEST SITE
- Area of exposure: 3 x 3 cm
- Type of wrap if used: occlusive dressing

SCORING SYSTEM: according to OECD guideline 404
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 hrs
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 hrs
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: mean 24, 48 and 72 hrs
Score:
0
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: mean 24, 48 and 72 hrs
Score:
0
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: mean 24, 48 and 72 hrs
Score:
0
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: mean 24, 48 and 72 hrs
Score:
0.3
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: mean 24, 48 and 72 hrs
Score:
0.3
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean 24, 48 and 72 hrs
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: mean 24, 48 and 72 hrs
Score:
0
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: mean 24, 48 and 72 hrs
Score:
0
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: mean 24, 48 and 72 hrs
Score:
0
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: mean 24, 48 and 72 hrs
Score:
0
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was found to cause erythema or edema (very slight to moderate) 1 hr after removal of the patch. At 24 hrs only very slight reactions were observed in 2 animals and no effects occurred 72 hrs p.a. No classification was derived from the results of this study.
Executive summary:

The test substance was applied to the intact skin of 6 rabbits. The duration of exposure was 4 hours. Occlusive dressings were used. Readings were made 1, 24, 48 and 72 hours after exposure.

The test substance was found to cause erythema or edema (very slight to moderate) 1 hr after removal of the patch. At 24 hrs only very slight reactions were observed in 2 animals and no effects occurred 72 hrs p.a.

No classification was derived from the results of this study.

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

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1985
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
not specified
Species:
rabbit
Strain:
not specified
Remarks on result:
other: No individual data are available.
Irritant / corrosive response data:
The substance is described as slightly irritating.
Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
The test item was slightly irritating to the eyes of rabbits.
Executive summary:

A test was performed according to the OECD-method. The test item was slightly irritating to the eyes of rabbits.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation/corrosion: Seven studies are available. The results of the studies range in most cases between not irritant and strong irritant, by using different methods. Only 1 study, that of Shapiro 1979, found the substance to be corrosive to the skin. This study and the classification criteria used are not compatible with the OECD-method or EU-classification.

The selected key study is the most recent study, it was performed according to the OECD-method and GLP and was performed to clarify the different results reported earlier.

Eye irritation: Four studies are available. Only one study, the most recent one of Suberg 1985, was performed according to the OECD-method. The other 3 studies give an indication that an eye irritation will occur, when the substance is applied to the eye, but they are not useful for classification purposes.


Justification for selection of skin irritation / corrosion endpoint:
The most recent study according to the OECD-method and GLP is selected. It was performed to clarify the different results ranging from no irritation to corrosion reported previously.

Justification for selection of eye irritation endpoint:
The most recent study and the only one performed according to the OECD-method is selected.

Effects on eye irritation: irritating

Justification for classification or non-classification

Skin irritation/corrosion: No relevant skin irritation was detected in the selected key study.

Eye irritation: Irritations were observed in each of the studies. The key study reports "slight irritation".