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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
Study period:
November 22, 2010 - November 26, 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study has been performed in accordance with OECD 404 (2002), EU Method B.4 (2008), EPA OPPTS 870.2500 (1998) and according to GLP principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
(2008)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Version / remarks:
(1998)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): F10Fine
- Physical state: colourless solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 13 - 14 weeks
- Weight at study initiation: 3.4 - 3.5 kg
- Housing: individually in ABS - plastic rabbit cages
- Diet: ad libitum (autoclaved hay and Altromin 2123 maintenance diet)
- Water: ad libitum (tap water)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: the substance was moistened with aqua ad injectionem
Controls:
other: the untreated right side of the dorsal area served as control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g

VEHICLE
- Vehicle: aqua ad injectionem (Delta Select, lot no. 05007A, expiry date: June 2013)
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 females (1 female subsequently followed by 2 females)
Details on study design:
TEST SITE
Approximately 25 hours before treatment, the dorsal fur was clipped with electric clippers.
The test item was applied to a gauze patch and was moistened with aqua ad injectionem.
The patch was then applied to the skin on a small area (approx. 6 cm^2) on the left side of the dorsal area.
The gauze was held in place with non-irritating tape. The patch was fixed with a semi-occlusive dressing.

REMOVAL OF TEST SUBSTANCE
- Washing: yes, using aqua ad injectionem
- Time after start of exposure: 4 hours

OBSERVATIONS
- Clinical signs: approximately 1, 24, 48 and 72 hours after patch removal
- Body Weight: at the start of the study and 72 hours after patch removal
- Irritation: the skin reactions were assessed at approximately 1, 24, 48 and 72 hours after patch removal. The irritation scores and a description of all other (local) effects were recorded.

SCORING SYSTEM
The irritation was assessed according to the numerical scoring system according to OECD 404.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2 and #3
Time point:
other: Mean value of score at 24, 48 and 72h after patch removal
Score:
0
Max. score:
4
Remarks on result:
other: No irritant or corrosive effects were observed
Irritation parameter:
edema score
Basis:
animal: #1, #2 and #3
Time point:
other: Mean value of score at 24, 48 and 72h after patch removal
Score:
0
Max. score:
4
Remarks on result:
other: No irritant or corrosive effects were observed
Irritant / corrosive response data:
No irritant or corrosive effects were observed
Other effects:
- No significant clinical signs of toxicity were observed
- No mortalities were observed
- No significant body weight changes were observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a skin irritation study with rabbits, performed in accordance with OECD 404 (2002), EU Method B.4 (2008), EPA OPPTS 870.2500 (1998) and according to GLP principles, no irritation was observed.
Executive summary:

In an in vivo skin irritation study in rabbits, conducted in accordance with OECD 404 (2002), EU Method B.4 (2008), EPA OPPTS 870.2500 (1998) and according to GLP principles, 3 female rabbits were semi-occlusively exposed for 4 hours to 0.5 g of the (moistened) substance. No irritant or corrosive effects were observed. No significant clinical signs of toxicity nor mortalities were observed. Based on the result of this study, the substance does not need to be classified for skin irritation/corrosion in accordance with the CLP Regulation.