Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with GLP and OECD guideline, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
gas under pressure: liquefied gas
Details on test material:
- Storage conditions: Room temperature and humidity

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Inc, Denver PA USA
- Weight at study initiation: 2.7 - 3.4 kg
- Housing: individually in suspended cages; absorbant paper beneath cages was changed at least 3 times a week
- Diet: ad libitum, PMI Rabbit Chow (Diet #5321)
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled and monintored but specific details not provided in report
- Humidity (%): controlled and monitored but specific details not included in report
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours/12hours

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours following patch removal
Number of animals:
3 (1 male, 2 females)
Details on study design:
Approx. 24 hours prior to application of the test article, the dorsal area of the trunk of each animal was clipped free of hair. Each dose sit was approx. 6 cm2. The test article was dosed by volume, 0.5 mL/site and placed over a 2x3 cm gauze patch. Gentle pressure was applied to aid in the distribution of the test article over the prepared site. The patch was secured with non-irritating tape. The torsi was covered with a piece of porous dressing (semi-occlusive) large enough to cover the dose site with at least 5 cm square to spare on all sides of the gauze patch. Porous, non-irritating tape was used to encircle the trunk of the animal. The test substance was kept in contact with the skin for 4 hours at which the wrappings and patches were removed. Residual test article was removed from the test site by gently washing with distilled water at the end of the exposure period, prior to scoring for dermal reactions.
The test sites were scored for dermal irritation at 1, 24, 48, 72 hours following patch removal. Erythema and edema were scored according to the numerical Draize technique. The skin was also evaluated for ulceration and necrosis or any evidence of tissue destruction.
Body weights were recorded pretest and at termination. Animals were observed for mortality, toxicological and pharmacological effects at each dermal observation period.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Average 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Average 24, 48, and 72 hours
Score:
0
Max. score:
4
Irritant / corrosive response data:
No irritation or corrosion observed in any of the 3 rabbits at any time point
Other effects:
No abnormal physical signs were observed. All three animals experienced body weight gain.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an OECD guideline 404 study conducted in compliance with GLP, the test substance was not irritating to the skin.
Executive summary:

In a skin irritation study performed in accordance with GLP and OECD guideline 404 three New Zealand White rabbits were exposed semi-occlusive to the test substance. After 4 hours of exposure the test article was removed and the skin was examined 1, 24, 48 and 72 hours after termination of exposure. No erythema or edema was noted at any observation period. No abnormal physical signs were observed. All three animals experienced body weight gain. The test substance was found not to be skin irritant when applied topically to the rabbit.