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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: Basic data provided

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
BASF-Test (Patch-Test)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diethanolamine, Substance-No. XVII/144 (pure) and XVII/146 (technical grade)

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
- Weight at study initiation: 2.7 - 3.65 kg
- Housing: individual
- Diet: ad libitum
- Water: ad libitum

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 2 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
1, 5, 15 min and 20h
Observation period:
8 days
Number of animals:
2 animals for 20 h experiment and
2 animals for 1, 5, 15 min experiment
Details on study design:
- Area of exposure: shaved skin of the back
- % coverage: patch test, otherwise no data



REMOVAL OF TEST SUBSTANCE
- Washing (if done): lutrol concentrated and lutrol diluted in water (50%)
- Time after start of exposure: 1, 5, 15 min, respectively


SCORING SYSTEM: The original scoring system was converted into Draize scores

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
20 h treatment
Basis:
animal #1
Time point:
other: at substance removal
Score:
3
Max. score:
4
Remarks on result:
other: anaemic areas
Irritation parameter:
erythema score
Remarks:
20h treatment
Basis:
animal #2
Time point:
other: at substance removal
Score:
3
Max. score:
4
Irritation parameter:
erythema score
Remarks:
20 h treatment
Basis:
animal #1
Time point:
other: 24 h
Score:
3
Max. score:
4
Irritation parameter:
erythema score
Remarks:
20h treatment
Basis:
animal #2
Time point:
other: 24 h
Score:
3
Max. score:
4
Irritation parameter:
erythema score
Remarks:
20 h treatment
Basis:
animal #1
Time point:
other: 48 h
Score:
3
Max. score:
4
Remarks on result:
other: anaemic areas
Irritation parameter:
erythema score
Remarks:
20 h treatment
Basis:
animal #2
Time point:
other: 48 h
Score:
3
Max. score:
4
Irritation parameter:
erythema score
Remarks:
20 h treatment
Basis:
animal #1
Time point:
other: 72 h
Score:
0
Max. score:
4
Remarks on result:
other: pergamentry red-yellowish necrosis
Irritation parameter:
erythema score
Remarks:
20 h treatment
Basis:
animal #2
Time point:
other: 72 h
Score:
2
Max. score:
4
Remarks on result:
other: spotted appearance
Irritation parameter:
erythema score
Remarks:
20h treatment
Basis:
animal #1
Time point:
other: 8 days
Score:
0
Max. score:
4
Remarks on result:
other: strong desquamation
Irritation parameter:
erythema score
Remarks:
20h treatment
Basis:
animal #2
Time point:
other: 8 days
Score:
0
Max. score:
4
Remarks on result:
other: strong desquamation
Irritation parameter:
edema score
Remarks:
20 h treatment
Basis:
animal #1
Time point:
other: at substance removal
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Remarks:
20 h treatment
Basis:
animal #2
Time point:
other: at substance removal
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 3 days
Irritation parameter:
edema score
Remarks:
20 h treatment
Basis:
animal #1
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Remarks:
20 h treatment
Basis:
animal #2
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Remarks:
20 h treatment
Basis:
animal #1
Time point:
other: 48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Remarks:
20 h treatment
Basis:
animal #2
Time point:
other: 48 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 3 days
Irritation parameter:
edema score
Remarks:
20 h treatment
Basis:
animal #1
Time point:
other: 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
20 h treatment
Basis:
animal #2
Time point:
other: 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
There was no difference in the erythema and edema scores following treatment with DEA pure (XVII/144) and DEA technical grade (XVII/146).

Any other information on results incl. tables

Readings

Animal

Exposure period: 1 min

Erythema

Edema

Additional findings

24 h

1

0

0

2

0

0

48 h

1

0

0

2

0

0

72 h

1

0

0

2

0

0

7 d

1

0

0

2

0

0

Mean 24, 48, 72 h

1

0

0

2

0

0

Mean 24, 48, 72 h

1-2

0

0

Readings

Animal

Exposure period: 5 min

Erythema

Edema

Additional findings

24 h

1

0

0

2

0

0

48 h

1

0

0

2

0

0

72 h

1

0

0

2

0

0

7 d

1

0

0

2

0

0

Mean 24, 48, 72 h

1

0

0

2

0

0

Mean 24, 48, 72 h

1-2

0

0

Readings

Animal

Exposure period: 15 min

Erythema

Edema

Additional findings

24 h

1

1

0

2

1

0

48 h

1

1

0

2

1

0

72 h

1

0

0

2

0

0

8d

1

0

0

2

0

0

Mean 24, 72 h

1

0.66

0

2

0.66

0

Mean 24, 48, 72 h

1-2

0.66

0

Readings

Animal

Exposure period: 20 hours

Erythema

Edema

Additional findings

24 h

1

3

2

anaemic areas

2

3

2

48 h

1

3

2

anaemic areas

2

3

2

72 h

1

0

0

pergamentry red-yellowish necrosis

2

2

0

spotted appearance

8d

1

0

0

strong desquamation

2

0

0

strong desquamation

Mean 24,  72 h

1

2

1.33

2

2

1.33

Mean 24, 48, 72 h

1-2

2

1.33

In all animals a slight irritation (reddening) is observed immediately after substance removal. It is unclear if this reddening is substance related or might result from the treatment precedure (patch removal and washing with lutrol).

Applicant's summary and conclusion