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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
Study period:
05 July 2006 to 31 August 2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
439-910-1
EC Name:
-
Cas Number:
93705-66-9
Molecular formula:
C23H28O4
IUPAC Name:
2,2'-(methylenebis((2,6-dimethyl-4,1-phenylene)oxymethylene))bis oxirane
Test material form:
solid
Details on test material:
- Appearance: white solid
- Storage conditions of test material: room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: animals were individually housed in suspended cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 - 23 °C
- Humidity: 30 - 70 %
- Air changes: at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Remarks:
the test material was moistened with 0.5 mL of distilled water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5g of test material moistened with 0.5 mL of distilled water
Duration of treatment / exposure:
3 minutes, 1 and 4 hours
Observation period:
72 hours following patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: On the day before the test each rabbit was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study. On the day before the test each rabbit was clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
- Type of wrap if used: Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset and the animal was returned to its cage for the duration of the 1 and 4 hour exposure periods.

REMOVAL OF TEST SUBSTANCE
One patch was removed at each of three time points: 3 minutes, 1 hour and 4 hours after application. Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.

OBSERVATION TIME POINTS
Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the Draize scale.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
- 3-Minute Exposure Period: No evidence of skin irritation was noted during the study.
- 1-Hour Exposure Period: No evidence of skin irritation was noted during the study.
- 4-Hour Exposure Period: No evidence of skin irritation was noted during the study.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to EU criteria
Conclusions:
Under the conditions of this study the test material was determined to be non-irritating to the skin.
Executive summary:

The potential of the test material to cause irritation to the skin was determined in accordance with the standardised guidelines OECD 404 and EU Method B.4, under GLP conditions, using an in-vivo method.

During the study, three New Zealand White rabbits were treated with the test material under a semi-occlusive dressing for 3 minutes, 1 hour and four hours. After the removal of the test material the skin was observed at 1, 24, 48 and 72 hours for cutaneous irritation.

No signs of irritation were noted.

Under the conditions of this study the test material was determined to be non-irritating to the skin.