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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restricitons.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
lack of details on test substance
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
lack of details on test substance
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Optimet TM RG
IUPAC Name:
Optimet TM RG
Details on test material:
- Name of test material (as cited in study report): Optimet TM RG
- Analytical purity: not reported
- Lot/batch No.: Batch No.10GUS013
- Physical state: solid

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
Not reported

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
other: Adjacent surfaces of untreated skin served as a control for the trial.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:
Semi-occlusive dressings held the test item in place for 3 minutes, 1 hour and 4 hours on the skin of the first animal and for 4 hours for the two other animals.
Observation period:
Any cutaneous lesion was evaluated approximately one hour, 24, 48 and 72 hours after removal of the dressing.
Number of animals:
3
Details on study design:

SCORING SYSTEM: Draize score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
No cutaneous lesion was observed.

Any other information on results incl. tables

Under the experimental conditions adopted, Optimet TM RG (Batch No.10GUS013) was found to be not irritating for the skin of the rabbit.

Classification according to DSD (Directive No.67/548/EEC) and subsequent amendments and CLP (Regulation No.1272/2008) is not required.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: DSD and CLP
Executive summary:

Bouchard, A. (2010)

In a primary dermal irritation study, the skin irritation/corrosion potential of Optimet TM RG (Batch No.10GUS013) was tested. 0.5 g of the test substance was applied on the skin of 3 rabbits under semi-occlusive conditions for 3 minutes, 1 hour and 4 hours on the skin of the first animal and for 4 hours for the two other animals.

The application of the test item did not induce colouring of the application site and did not interfere with grading of any skin lesion.

Any cutaneous lesion was evaluated approximately one hour, 24, 48, and 72 hours.

No other cutaneous lesion was observed.

Under the experimental conditions adopted, the test item was found to be a non skin irritant.

On the basis of the results of the present study, classification according to Directive No. 67/548/EEC and subsequent amendments and CLP regulation No. 1272/2008 is not required.