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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo study already available
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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1957
Report Date:
1957

Materials and methods

Principles of method if other than guideline:
Before OECD Guideline 404 was established, skin irritation was tested using an internal BASF method. The undiluted substance was applied to the clipped back (2.5 X 2.5 cm) of 2-4 animals for short periods of time (1, 5 and 15 mins). At the end of treatment, the application site was washed first with lutrol and then with 50% aqueous lutrol solution. The animals were observed for up to 53 days and skin changes were assessed and scored.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Source: Nonylfabrik (Hochdruck Abteilung)
Analytical purity: > 99%

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.25-2.85 kg

ENVIRONMENTAL CONDITIONS
- no data

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
- Concentration (if solution): undiluted
Duration of treatment / exposure:
1, 5, 15 min
Observation period:
53 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap if used: no data

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

SCORING SYSTEM: The test was initially scored using a BASF numerical skin grading system. Later these scores were converted to the scoring system by Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(after 1 min of exposure)
Basis:
mean
Remarks:
(4 animal)
Time point:
other: 24 and 72 hour
Score:
1.25
Max. score:
4
Reversibility:
fully reversible within: 30 days
Remarks on result:
other: crust formation (after 8 days) and scaling (till 30 days) were apparent
Irritation parameter:
erythema score
Remarks:
(after 5 mins of exposure)
Basis:
mean
Remarks:
(of 4 animals)
Time point:
other: 24 and 72 hours
Score:
1.9
Max. score:
4
Reversibility:
fully reversible within: 23 days
Remarks on result:
other: Brown and anaemic skin colouration was evident shortly after removal of patch (lasted up to 8 days after application). Necrosis and crusty skin from 24 h post termination of exposure was apparent. Scar tissue at end after 53 days
Irritation parameter:
erythema score
Remarks:
(exposure duration of 15 min)
Basis:
mean
Remarks:
(2 animals)
Time point:
other: 24 and 72 hours
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: Necrosis was evident as from 24 h post termination of exposure. Crust formation induced after 72. At termination (53 days) bloody and deep penetrative scars were apparent.
Irritation parameter:
edema score
Remarks:
(after 1 min of exposure)
Basis:
mean
Remarks:
(of 4 animals)
Time point:
other: 24 and 72 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
(after 5 min of exposure)
Basis:
mean
Remarks:
(of 4 animals)
Time point:
other: 24 and 72 hour
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Remarks:
(after 15 min of exposure)
Basis:
mean
Remarks:
(of 2 animals)
Time point:
other: 24 and 72 h
Score:
1.5
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritant / corrosive response data:
- Necrosis after exposure periods of 5 and 15 minutes of exposure
- Crustaceous tissue was present after 1 minutes of exposure

Any other information on results incl. tables

Table 1: Results after 15 min duration

 

Animal

Animal

Erythema

Edema

Further findings

Immediately after removal of patch   (15 min)

1

3

3

Anemic appearance, erythema at edges

2

3

3

Anaemic appearance, erythema at edges and oedema

 

24h

1

3

0

Anemic appearance, erythema at edges

2

3

3

Brown discolouration, anaemic appearance, erythema at elevated edges

 

72h

1

3

0

Anaemic application site with reddened edges and oedema, beginning necrosis

2

3

3

Penetrative crust, reddened edges

8d

1

3

0

Brown and partly anaemic necrosis with reddened edges

2

0

0

necrosis

15d

1

0

0

Hardened penetrative crust

2

 0

0

Bloody penetrative scar

53 d      (8 weeks)

1

0

 0

Scar

2

0

 0

Bloody penetrative scar

Mean scores (24-72h)

1

3

3

 

2

3

0

 

 

Table 2: Results after 5 min exposure duration

Readings

Animal

Erythema

Edema

Further findings

At removal (after 5 min)

1

3

3

Anaemic in the middle with reddened and oedematous edges

2

3

3

3

3

3

4

3

3

24h

1

3

3

Anaemic in the middle with reddened and oedematous edges

2

3

0

Brown discolouration in the middle, partly anaemic with reddened elevated edges

3

3

0

Anaemic in the middle, partly brown necrotic tissue with reddened edges

4

0

0

Anaemic in the middle, partly brown discolouration

72h

1

3

0

Anaemic leather-like crust

2

3

0

Anaemic crust with reddened edges, partly brown

3

0

0

Deep penetrative crust

4

0

0

Anaemic in the middle, partly brown discolouration

8d

1

3

0

Anaemic necrosis with reddened edges

2

3

0

Deep penetrative crust with reddened elevated edges

3

0

0

-

4

0

0

Anaemic crust with reddened edges

15d

1

0

0

Hard deep and penetrative crust

2

0

0

Crust partly detached

3

0

0

-

4

0

0

-

23 d

1

0

0

Hard deep and penetrative crust

2

0

0

Detaching crust/bloody scar

3

0

0

Deep penetrative and bloody crustaceous scar

4

0

0

Thick yellow crust, partly detached

8 weeks (53 d)

1

0

0

Scaring tissue

2

0

0

Bloody scar/extensive scar

3

0

0

Scar with increased hair growth

4

0

0

Deep penetrative and bloody crustaceous scar

MW (24-72h)

1

3

1.5

 

2

3

0

 

3

1.5

0

 

4

0

0

 

 

Table 3: Results after 1 min exposure duration

Readings

Animal

Erythema

Edema

Further findings

At removal (after 1 min)

1

2

0

-

2

2

0

bleeding

3

2

3

-

4

2

3

 

24h

1

1

0

 

2

1

0

 

3

2

2

 

4

2

0

 

72h

1

0

0

 

2

0

0

Symptom free

3

2

2

-

4

2

0

 

8d

1

0

0

scaling

2

0

0

-

3

2

0

Scaling, crusty edges

4

0

0

Symptom free

15d

1

0

0

 

2

0

0

 

3

0

0

 

4

0

0

 

30 d

1

0

0

Increased hair growth

2

0

0

-

3

0

0

scaling

4

0

0

scaling

MW (24-72h)

1

0.5

0

 

2

0.5

0

 

3

2

2

 

4

2

0

 

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information