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: Meets generally accepted scientific standards, well documented and acceptable for assessment. Purity of the test material was not listed.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1966
Report Date:
1966

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 according to internal standard operating procedure
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): monoethanolamine
- no further data

Test animals

Species:
rabbit
Strain:
Vienna White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Duration of treatment / exposure:
1, 5, 15 min, 20 hrs
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 1, 5 and 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:
1 min exposure
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
1 min exposure
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Remarks:
5 min exposure
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
5 min exposure
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.16
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Remarks:
15 min exposure
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.83
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
15 min exposure
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.66
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Remarks:
20 hr exposure
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
3
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Remarks:
20 hr exposure
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Other effects:
bleedings and necrosis of the skin

Any other information on results incl. tables

 

Readings

Animal

Exposure period: 1 min

Erythema

Edema

Additional findings

1 min

1

2

0

spotted appearance

2

0

0

 

24 h

1

2

0

spotted appearance

2

1

0

 

48 h

1

2

0

spotted appearance

2

1

0

 

72 h

1

2

0

spotted appearance

2

0

0

 

8 d

1

0

0

slight desquamation

2

0

0

 

Mean 24, 48, 72 h

1

2

0

 

2

0.66

0

 

Mean 24, 48, 72 h

1-2

1.33

0

 

 

Readings

Animal

Exposure period: 5 min

Erythema

Edema

Additional findings

5 min

1

2

0

pea-sized spotted erythema, bleedings

2

3

0

bleedings

24 h

1

2

0

spotted appearance

2

2

2

grey-brown appearance

48 h

1

2

0

spotted appearance

2

0

0

leather-like necrosis

72 h

1

2

0

spotted appearance

2

0

0

brown-red leather-like necrosis, partly anaemic

8 d

1

0

0

pea-sized crusts, desquamation

2

0

0

brown-red leather-like necrosis, partly anaemic

Mean 24, 48, 72 h

1

2

0

 

2

1

0.33

 

Mean 24, 48, 72 h

1-2

1.5

0.16

 

 

Readings

Animal

Exposure period: 15 min

Erythema

Edema

Additional findings

15 min

1

2

0

bleedings

2

3

0

bleedings

24 h

1

2

2

pea-sized brown erythema

2

2

0

grey-brown spotted appearance, bleedings

48 h

1

2

2

pea-sized brown erythema

2

0

0

leather-like anaemic necrosis exceeding area of exposure

72 h

1

3

0

pea-sized crusts, spotted appearance

2

0

0

brown-red leather-like necrosis, partly anaemic

8 d

1

0

0

pea-sized crusts, desquamation

2

0

0

brown-red leather-like necrosis, partly anaemic

Mean 24, 48, 72 h

1

2

1.33

 

2

1.66

0

 

Mean 24, 48, 72 h

1-2

1.83

0.66

 

 

Readings

Animal

Exposure period: 20 hours

Erythema

Edema

Additional findings

24 h

1

3

2

grey-brown, exceeding area of exposure

2

3

2

grey-brown anaemic necrosis,

48 h

1

3

2

grey-brown, exceeding area of exposure

2

3

0

black brown hard necrosis

72 h

1

3

2

black-brown slideable necrosis

2

3

0

black brown hard necrosis

8 d

1

3

2

black-brown slideable necrosis

2

3

0

black brown hard necrosis

Mean 24, 48, 72 h

1

3

2

 

2

3

0.66

 

Mean 24, 48, 72 h

1-2

3

1.33

 

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information