Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 14 to 24 Jan 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study run to a method comparable with current guidelines and to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch No.: SKN045-008
Purity: Not specified

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, Oxon, UK.
- Age at study initiation: 12 to 20 weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: Individually housed in suspended cages.
- Diet (e.g. ad libitum): Free access to mains food.
- Water (e.g. ad libitum): Free access to mains drinking water.
- Acclimation period: At least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23℃
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (06:00 to 18:00) and 12 hours darkness.

IN-LIFE DATES: From: 14 Jan 2009 To: 24 Jan 2009

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity:
Duration of treatment / exposure:
For the first animal: 3 mins, 1 hour and 4 hours
For the other two animals: 4 hours
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
One rabbit was initially treated. Three suitable sites were selected on the back of the rabbit. At each test site a quantity of 0.5 g of the test material, moistened with 0.5 mL of distilled water, was introduced under a 2.5 cm × 2.5 cm cotton gauze patch and placed in position on the shorn skin. 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 for the duration of the exposure period.
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.
After consideration of the skin reactions produced in the first animal, two additional animals were treated with 0.5 g of test material moistened with 0.5 mL of distilled water. 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.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
ca. 0.44
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: The exposure period is 4 hours.
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
ca. 0.11
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: The exposure period is 4 hours.
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:
Very slight erythema was noted at one treated skin site one hour after patch removal. Well-defined erythema and very slight oedema were noted at one treated skin site and very slight erythema was noted at one other treated skin site at the 24-hour observation. Very slight erythema was noted at one treated skin site at the 48-hour observation.
One treated skin site appeared normal at the 48-hour observation and one other treated skin site appeared normal at the 72-hour observation. One treated skin site appeared normal throughout the test.
Other effects:
All animals showed expected gain in bodyweight during the study.

Any other information on results incl. tables

Individual skin reactions following 4-hour exposure

Skin reaction

Observation time

Individual scores-Rabbit number and sex

68120 Male

68163 Male

68164 Male

Erythema/Eschar formation

1 hour

24 hours

48 hours

72 hours

0

0

0

0

1

2

1

0

0

1

0

0

Oedema formation

1 hour

24 hours

48 hours

72 hours

0

0

0

0

0

1

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was mildly irritating to rabbit skin.