Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 days
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Modern GLP study conducted in accordance with modern guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Individual animal bodyweight data at the start and end of the test are not provided in the study report
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Individual animal bodyweight data at the start and end of the test are not provided in the study report
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch number: E0011-039E

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan UK
- Age at study initiation: 12–20 weeks of age
- Weight at study initiation: 2.0–3.5 kg
- Housing: Individually housed in suspended cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): set to achieve 17–23 deg C
- Humidity (%): set to achieve 30–70%
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12 (06:00–18:00)


IN-LIFE DATES:
From: 24/01/08 To: 27/01/08

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.5 g test material, moistened with 0.5 ml distilled water
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
0.5 g of test material moistened with 0.5 ml of distilled wwater was introduced under a 2.5cm x 2.5cm cotton gauze patch and placed in position on the shorn dorsal/flank skin. The patch was secured in place with a strip of surgical tape. To prevent animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset.

After four hours of exposure, the corset and patches were removed and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.

Test sites were examined and scored for for evidence of primary irritation using the Draize scale, 1, 24, 48 and 72 hours after patch removal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: Not applicable
Remarks on result:
other: No erythema was observed in any animal at any time point
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1, 24, 48 and 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: Not applicable
Remarks on result:
other: No oedema was seen in any animal at any time point
Irritant / corrosive response data:
The primary irritation index was 0 (zero).
Other effects:
No other effects were reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test material was not irritating to the skin of rabbits in this test.
Executive summary:

The test material was evaluated for dermal irritation potential in three male New Zealand white rabbits, in accordance with OECD Test Guideline 404. The test material was applied to each animal at a dose of 0.5g, moistened with 0.5ml distilled water, and held in place using a semi-occlusive dressing. After four hours the patches and residual test material were removed. Test sites were observed for evidence of erythema and oedema 1, 24, 48 and 72 hours after patch removal.

There was no evidence of irritation, measured either as erythema or oedema, in any animal at any time point.