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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: OECD guideline study with acceptable restrictions (no test substance purity given). Acceptable, well documented report which meets basic scientific principles.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted 1981)
Deviations:
yes
Remarks:
compared to OECD TG 404 (2002): observation period 72 h instead of 14 days
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Lupragen N 107
- Analytical purity: no data

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Weight at study initiation: 2.99, 2.64 kg (males); 2.87 kg (female)
- Housing: 1 animal per cage
- Diet: KLIBA 341, 4 mm; Klingentalmuehle AG, CH, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 30 - 70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped at least 15 h before application
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): about 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3 (2 males, 1 female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: Test patches were secured in position with a porous dressing (4 layers of absorbent gauze + porous bandage).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize Scoring System

READINGS
30 - 60 minutes after removal of the test patches and 24 h, 48 h, and 72 h after the beginning of application

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: necrosis
Basis:
mean
Time point:
72 h
Reversibility:
not reversible
Remarks on result:
other: All three animals showed full thickness necrosis at the end of the observation period.
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.4
Max. score:
4
Reversibility:
not fully reversible within: 72 h

Any other information on results incl. tables

Results skin irritation: (animal 1/2/3)

 Reading:  Erythema  Edema  Symptoms    
 4 h 2/3/3  2/2/2  -/HE/HE     
 24 h 4/4/4   2/2/2 N/N/N     
 48 h 4/4/4   1/1/2 N/N/N     
 72 h 4/4/4   1/1/1  TN+/TN+/TN+    

HE: hemorrhage

N: necrosis.

TN: Full thickness necrosis.

+: findings confirmed by gross pathology examination.

After 4 h exposure hemorrhages were seen and after 24 necrosis occured in all three animals. At the end of the observation period at 72 h full thickness necrosis was observed in all three animals. Full thickness necrosis was confirmed by gross-pathological examination.

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria