Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-05-27 until 2003-09-22
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:
2003
Report Date:
2003

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: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: 3.7 - 3.9 kg
- 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:
As all animals showed signs of irritation at the 72 hours readings, observation time was prolonged until 168 hours after dosing
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

SCORING SYSTEM: as stated in Guideline OECD 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1-3
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 168 hours
Irritation parameter:
edema score
Basis:
animal: 1-3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
0
Other effects:
No other clinical signs of toxicity were found. There were no significant body weight changes during the contact and observation period

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Considering the reported data of this irritation study it can be stated that the test item showed slight irritant, but no corrosive effects.
According to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21 EEC) the test item SLM 449019 does not have to be classified and has no obligatory labelling requirement for skin irritation.
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 HsdIf:NZW and held in contact throughout a 4 hour period. The test item showed slight irritant effects on the intact skin after a contact time of 4 hours. All animals showed erythema grade 1 at the 1 h, 24 h, 48 h, 72 h, 96 h, 120 h as well as 144 hours readings after removal of the dressing. No signs of irritation were recorded for any animals at the 168 hours readings. No other clinical signs of toxicity were found. There were no significant body weight changes during the contact and observation period. Therefore, the test item does not have to be classified and has no obligatory labelling requirement for skin irritation.