Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005-05-09 until 2005-05-18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD test under GLP
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, D-88353 Kisslegg
- Weight at study initiation: 2.2 kg all animals
- Housing: semi barrier in an air-conditioned room
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: adequate


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3 °C
- Humidity (%): 55 +/- 10 % rel. humidity
- Air changes (per hr): at least 10/h
- Photoperiod (hrs dark / hrs light): 12 h dark, 12 h light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated but shaved other side served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm2
- Type of wrap if used: gauze patch held with non-irritating tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test item was removed by using tap water.
- Time after start of exposure: 4 hours


SCORING SYSTEM: as stated in Guideline OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal: 1-3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: max. duration of any effect: d; Max. value at the end of the observastion period: 0 (related to all animals)
Irritation parameter:
erythema score
Basis:
animal: 1-3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: max. duration of any effect: d; Max. value at the end of the observastion period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal: 1-3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Remarks on result:
other: max. duration of any effect: d; Max. value at the end of the observastion period: 0 (related to all animals)
Other effects:
No treatment related effects observed.

Any other information on results incl. tables

Comments:

0.5 ml undiluted test item (density = 1.00155 mg/ml) were applied which corresponds to 501 mg.

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The substance is not irritating to the skin of rabbits.
Executive summary:

An acute dermal Irritation/Corrosion test according to OECD 404 was performed. The test item was semi-occlusively applied to the skin on 3 female New Zealand White Rabbits Crl:KBL (NZW) and held in contact throughout a 4 hour period. The test item showed no skin effects throughout the observation period. There were no significant body weight changes during contact and observation period. No treatment related effects were observed. Therefore, the substance should be not classified.