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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
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 guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River France
- Age at study initiation: minimum 10 weeks
- Weight at study initiation: minimum 2 kg
- Housing: individually housed in cages with perforated floors and shelters
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.2-20.1
- Humidity (%): 43-88
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours light /12 hours dark

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml


Duration of treatment / exposure:
4 hours
Observation period:
Skin reactions were assessed at ca. 1, 24, 48 and 72 hours after the removal of the dressing and test substance
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: dorsal skin
- Type of wrap if used: The test substance was applied to the skin of one flank using a metalline patch, which was mounted on micropore tape, which was wrapped around the abdomen and secured with elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): YES
- Time after start of exposure: 4 HOURS

SCORING SYSTEM: Similar to Draize

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:
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:
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:
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:
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 #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No erythema or oedema were observed in any of the test animals at any of the scoring intervals (1, 24, 48 and 72 hours) following a 4-hour exposure to the test substance. No staining of the treated skin by the test substance was observed and no test substance remnants were seen.
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was found not irritating to the skin of rabbits in a 4 hour occlusive study, conducted according to current OECD Test Guideline 404 and in compliance with GLP.