Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The temp. and relative humidity were set to achieve limits of 17 to 23 deg. C and 30 to 70% respectively. The rate of air exchange was at least 15 changes per hour and lighting was controlled.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
The study was performed to assess the irritancy potential of the test material following single, 3-minute, 1 and 4-hour, semi-occluded applications to the intact rabbit skin.
Observation period:
25
Number of animals:
3 rabbits
Details on study design:
At each test site a quantity of 0.5ml of the test material was introduced under a 2.5cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in positoin with a strip of surgical adhsesive tape. One patch was removed at each of thre time points: 3 minutes, 1 hour and 4 hours after applicatoin. After consideration of the skin reactions produced in the first animal, two additional animals were treated with 0.5ml of test material. one patch was applied to the back of each rabbit , and was allowed to remain in contact with the skin for a period of four hours.
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 irritaiton and scored.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Time point:
other: 24,72-hour
Score:
ca. 4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
4-hour Exposure Period:The individual scores for erythema/eshcar and oedema are given in Talbe 1.
Well-defined erythema and slight to moderate oedema were noted at all treated skin sites on hour after patch removal with well-defined erythema and slight oedema at the 24,48 and 72-hour observatoins. Loss of skin elasticity was noted at all treated sites at the 72-hour observation. Severe desquamation, which prevented evaluation of erythema and oedema, was noted at two treated skin sites with moderate desquamation noted at one other treated skin site at the 7-day observation. All treated skin sites appeared notrmal at the 14-day observation.

1-Hour Exposure Period: The individual scores for erythema/escjar amd pede,a are govem om Appendix 1. Well-defined erythema and very slight oedema were npoted at the treated skin site at the 24.48 and 72-hour observations. Loss of skin elasticity was noted at the treated skin site at the 72-hour observation. Slight desquamation was noted at the treated skin site at the 7-day observation. The treated skinsite appeared normal at the 14-day oservation.

3-Minute Exposure Period: The individual scores for erythema/eschar and oedema are given in Appendix 1. No evidence of skin irritation was noted during the study.

Applicant's summary and conclusion

Conclusions:

The test material produced a primary irritation index of 4.0 and was classified as a moderate irritant to rabbit skin accordingt to the Draize3 classification scheme. No corrosive effects were noted.
Executive summary:

The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit.

A single 4 -hour, semi-occluded application of the test material to the intact skin of three rabbits produced well-defined erythema and slight to moderate oedema. Other skin reactions noted were loss of skin elasticity and moderate or sever desquamation. All treated skin sites appeared normal at the14 -day observation. No corrosive effects were noted.

3 -minute and 1 -hour semi-occluded applications of the test material to the intact skin of one rabbit produced no corrosive effects.

Conclusion: The test material produced a primary irritation index of 4.0 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.

The test material was also classiifed as irritant accoridng to the EU labeling regulation.