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Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study in compliance with guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Corn, steep liquor
EC Number:
266-113-4
EC Name:
Corn, steep liquor
Cas Number:
66071-94-1
Molecular formula:
not applicable: UVCB substance
IUPAC Name:
Corn, steep liquor
Details on test material:
Name: Corn Steep Liquor
Batch: E108C
UVCB substance
Purity: 100%

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
Semi-occlusive dressings held the test item in place for 3 minutes, 1 hour and 4 hours on the skin for the first animals and for 4 hours on the skin for the two others animals.
Observation period:
Any cutaneous lesion was evaluated approximately one hour, 24, 48 and 72 hours for all the animals after removal of the dressing. Cutaneous lesion was evaluated at 8 days after removal of the dressing in 1/3 animal (first animal).
Number of animals:
Three animals

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 3 min
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 3 min
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 4 h
Score:
1
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 4h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable

Any other information on results incl. tables

One hour after removal of the dressing, 2/3 animals presented a slight erythema (score 1) after the 4 hours exposure time. This erythema persisted up to time 72 hours for the first animal and up to time 24 hours for one other animal. No cutaneous lesion persisted on D8 (for the first animal) or at time 72 hours (for the two others animals).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU