Registration Dossier

Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
Crl: KBL (NZW)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany,
- Age at study initiation: Approximately 22 weeks old
- Weight at study initiation: > 2 Kg
- Housing: Semi-barrier in an air conditioned room. Housed in ABS plastic rabbit cages.
- Diet (e.g. ad libitum): Free access to autoclaved hay and Altromin maintenance diet for rabbits.
- Water (e.g. ad libitum): Free access to tap water.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): At least 10
- Photoperiod (hrs dark / hrs light): Artificial light (12 hours light/dark cycle)

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Remarks:
Aqua ad injectionem
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of the test item was applied.

VEHICLE
- Amount(s) applied (volume or weight with unit): Only used to ensure good contact with the test substance and skin.



Duration of treatment / exposure:
Applied over a 4 hour period
Observation period:
Up to 72 hours after patch removal
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: Left side of dorsal area
- % coverage: approximately 6 cm3
- Type of wrap if used: the gauze used was held in place with non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): washed with tap water after 4 hours of exposure

OBSERVATION TIME POINTS
(indicate if minutes, hours or days): 1, 24, 48 and 72 hours after patch removal.

SCORING SYSTEM:
- Method of calculation: Scoring and grading as per standard system in relevant OECD guideline.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
In the initial animal, erythema grade 1 was observed immediately after patch removal and 1 hour after. The same effects were noted in animal 2 with no signs observed in animal number 3. No other signs of irritation were observed and the initial effects observed at 1 hour in the first two animals were completely reversible by the 24 hour observation point.
Other effects:
There were no significant bodyweight changes, clinical signs and no mortality observed in any animals.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of the study, the dermal application of the test substance showed no irritant or corrosive effects.