Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13 January 1998 to 20 January 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Test item: Structural Analogue 02

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Weight at study initiation: 3.1 - 3.8 kg
- Housing: Full air-conditioned rooms in separate cages arranged in a battery
- Diet (e.g. ad libitum): ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 50
- Photoperiod (hrs dark / hrs light): 12 hours daily

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Remarks:
deionized
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.4ml
Duration of treatment / exposure:
Exposure 4 hours
Observation period:
7 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5cm x 2.5 cm
- Type of wrap if used: surgical plaster

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: DRAIZE

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 3 days
Remarks on result:
probability of weak irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of mild irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
probability of weak irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
30-60 minutes and 24 hours after removal of the plaster the animals showed moderate erythema. Very slight oedema were observed 24 hours after removal of the plaster. 48 and 72 hours after removal of the plaster the animals showed very slight up to well defined erythema. 7 days after removal of the plaster all irritations were reversible.

Based on the individual scores for erythema and oedema after 24, 48 and 72 hours, the following mean values were calculated: Erythema and eschar formation all animals : 1.7
animal 66 : 1.3
animal 67 : 2.0
animal 68 : 1.7

Oedema formation all animals : 0.3
animal 66 : 0.3
animal 67 : 0.3
animal 68 : 0.3

Based on the results of this study the substance is slightly irritating to skin.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
30-60 minutes and 24 hours after removal of the plaster the animals showed moderate erythema. Very slight oedema were observed 24 hours after removal of the plaster. 48 and 72 hours after removal of the plaster the animals showed very slight up to well defined erythema. 7 days after removal of the plaster all irritations were reversible.
Based on the results of this study the substance is slightly irritating to skin. The substance does not meet the EU criteria for classification on the basis of the effects noted.
Executive summary:

This study is read across to a close structural analogue, which is considered to be structurally equivalent to the substance to be registered, in that only the halogen ion differs. The study was conducted according to EU test guidance 92/69/EEC part B4 and OECD guideline 404 in compliance with GLP.

30-60 minutes and 24 hours after removal of the plaster the animals showed moderate erythema. Very slight oedema were observed 24 hours after removal of the plaster. 48 and 72 hours after removal of the plaster the animals showed very slight up to well defined erythema. 7 days after removal of the plaster all irritations were reversible.

Based on the individual scores for erythema and oedema after 24, 48 and 72 hours, the following mean values were calculated:

Erythema and eschar formation

animal #1 : 1.3

animal #2 : 2.0

animal #3 : 1.7

Oedema formation

animal #1 : 0.3

animal #2 : 0.3

animal #3 : 0.3

Based on the results of this study the substance is slightly irritating to skin. The substance does not meet the CLP criteria for classification on the basis of the effects noted.