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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:
08 - 15 Oct 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
No information on purity was given. The reversibility of effects was observed only up to 7 days after removal of the patches.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
yes
Remarks:
no information on purity; 7-day observation period
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: approx. 12 - 16 weeks
- Weight at study initiation: 2.14 - 2.76 kg
- Housing: individually in suspended metal cages
- Diet: Rabbit Diet (A.W. Tindall Limited, Holbeach, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 20
- Humidity (%): 60 - 68
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
7 days
Reading time points: 1, 24, 48 and 72 h and 7 days
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back
- Type of wrap: The treated skin was covered with a gauze patch (2.5 cm x 2.5 cm), which was held in place with two lengths of adhesive strapping (sleek) in the form of a cross. To prevent the animals from interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP).

REMOVAL OF TEST SUBSTANCE
- Washing: The skin was cleaned of residual test substance by gentle swabbing with cotton wool soaked in ether.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: mean after 24/48/72 h
Score:
2.33
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: desquamation was observed on Day 7
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: mean after 24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: desquamation was observed on Day 7
Irritation parameter:
erythema score
Basis:
animal: #3 and #6
Time point:
other: mean after 24/48/72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: desquamation was observed on Day 7
Irritation parameter:
erythema score
Basis:
animal: #4 and #5
Time point:
other: mean after 24/48/72 h
Score:
2.67
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: desquamation was observed on Day 7
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: mean after 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal: #1 and #6
Time point:
other: mean after 24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: #3, #4 and #5
Time point:
other: mean after 24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
All test sites showed barely perceptible or well defined erythema with or without minimal oedema 1 h after removal of the patches. Similar reactions were noted after 24 h. By the 48 h observation moderate erythema had developed at 3 test sites while barely perceptible or well defined erythema persisted at the remaining 3 test sites. Minimal oedema was also seen at 5 test sites at this time. Barely perceptible to moderate erythema with or without minimal oedema persisted at all test sites at the 72 h reading. A final observation at Day 7 showed a reduction in the level of reaction when barely perceptible erythema with desquamation was noted at all 6 test sites.

Any other information on results incl. tables

1. Result of the irritation study.

Observation time

Rabbit no.

1

2

3

4

5

6

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

1 h

2

1

1

0

1

0

2

1

1

1

2

1

24 h

2

1

1

0

2

1

2

1

2

1

2

1

48 h

3

1

1

0

2

1

3

1

3

1

2

1

72 h

2

0

1

0

2

1

3

1

3

1

2

0

7 days

1

0

1

0

1

1

1

1

1

1

1

0

Mean value

24 + 48 + 72 h

2.33

0.67

1.00

0.00

2.00

1.00

2.67

1.00

2.67

1.00

2.00

0.67

Applicant's summary and conclusion

Interpretation of results:
other: Skin Irrit. Cat 2 according to Regulation (EC) No 1272/2008
Conclusions:
Under the conditions of the skin irritation study the test substance caused slight to moderate skin irritation (mean erythema values over 24, 48 and 72 h: 2.33, 1.0, 2.0, 2.67, 2.67, 2.0; mean edema values over 24, 48 and 72 h: 0.67, 0.0, 1.0, 1.0, 1.0, 0.67), which was not fully reversible after 7 days. Thus the test subtance is considered as Skin Irrit. Cat. 2 (H315) according Regulation EC (no) 1272/2008
Executive summary:

The skin irritation potential of the test substance was determined by an in vivo skin irritation test in rabbits according to OECD Guideline 404 and in compliance with GLP (1985). Treatment with test substance caused slight to moderate skin irritation (mean erythema values over 24, 48 and 72 h: 2.33, 1.0, 2.0, 2.67, 2.67, 2.0; mean edema values over 24, 48 and 72 h: 0.67, 0.0, 1.0, 1.0, 1.0, 0.67), which was not fully reversible after 7 days. Therefore, the test substance is considered to possess an irritant potential.