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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study report, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- Name of test material (as cited in study report): DEA, by-products
- no further data

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Germany
- Weight at study initiation: 2.78, 2.63, 2.88, 2.80, 2.73, 2.56 kg
- Housing: individual, stainless steel cages without beddings
- Diet Ovator Solikanin, Muskator-Werke, Düsseldorf, Germany; 130 g /day
- Water Tap water 250 ml/day
- Acclimation period: 8 days


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

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
6 (2 males, 4 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used:


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol 50% diluted in water
- Time after start of exposure: 4 hour


SCORING SYSTEM:
according to OECD Draize scores
Readings: 30-60 min, 24 h, 48 h, 72 h, 8 days after substance removal

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
1-6
Time point:
other: 24,48,72 h
Score:
2.27
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
1-6
Time point:
other: 24,48,72 h
Score:
1.06
Max. score:
4
Reversibility:
not fully reversible within: 8 days

Any other information on results incl. tables

 

Readings

Animal

Exposure period: 4 h

Erythema

Edema

Additional findings

4 h

1

2

1

R:U/OE:U

2

2

1

R:U/OE:U

3

2

1

R:U/OE:U/HE

4

2

1

R:U/OE:U

5

2

2

R:U/OE:U/HE

6

1

0

R:U

24 h

1

2

1

R:U/OE:U

2

2

1

R:U/OE:U

3

4

2

N/OE:U

4

2

1

R:U/OE:U

5

2

1

R:U/OE:U/HE

6

1

0

R:U

48 h

1

2

1

HE

2

3

1

R:U/OE:U/HE

3

4

2

N

4

2

1

 

5

2

1

R:U/OE:U/HE

6

1

0

R:U

72 h

1

2

1

HE

2

3

2

HE

3

4

2

N

4

2

1

 

5

2

1

R:U/OE:U/HE

6

1

0

R:U

8 d

1

1

0

S/+

2

1

0

S/+

3

4

2

N:TI/+

4

1

0

S/+

5

4

1

N:OB/+

6

1

0

S/+

Mean

24, 48, 72 h

1

2

1

 

2

2.66

1.33

 

3

4

2

 

4

2

1

 

5

2

1

 

6

1

0

 

Mean 24, 48, 72 h

1-6

2.27

1.055

 

Symbols:

HE     haemorrhagia

N       necrosis

N:TI    necrosis (deep)

N:OB necrosis (superficial)

OE:U oedema exceeding beyond area of exposure

S        desquamation

+         pathologically confirmed

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information