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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
Study period:
01/03 1989 to 15/03 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: conform the guideline, non-GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

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
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): p-menthane
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
other: white russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Tomae GmbH Biberach
- Sex: male
- Weight at study initiation: 2.2-2.4 kg
- Housing: individual
- Diet : K4 Alleindiät für Kaninchen, Ssniff Spezialfütter GmbH Soest, ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 01 March 1989 To: 15 March 1989

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 cm3
Duration of treatment / exposure:
4 hours
Observation period:
scored at 1, 24, 48 and 72 hours and after 6, 8, 10 and 14 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: scabs from day 6 onwards
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72 h
Score:
2.6
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: scabs from day 8 onwards
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48 and 72 h
Score:
2.6
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
not reversible
Remarks on result:
other: scabs from day 8 onwards
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72 h
Score:
2.3
Max. score:
4
Reversibility:
not reversible

Any other information on results incl. tables

 

 

1h

 

24 h

 

48 h

 

72 h

 

6 d

 

8 d

 

10 d

 

14 d

 

 

E

O

E

O

E

O

E

O

E

O

E

O

E

O

E

O

Animal 1

3

4

2

4

2

2

2

2

3*

3

scabs

scabs

Loose scabs

Animal 2

2

4

2

4

2

2

2

2

2#

2

scabs

scabs

Loose scabs

Animal 3

2

4

2

4

2

2

2

1

3*

3

scabs

scabs

Loose scabs

*Redbraun discoloration and dryness of the skin

#Redbraun discoloration of the skin

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test substance is considered moderately irritant to the skin
Executive summary:

Dermal application of the test substance to rabbits resulted in erythema and necrosis after 4 hours exposure. The test substance is considered irritant to the skin.