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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:
September 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with no GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics
Deviations:
yes
Remarks:
Test performed with three rabbits and three preparations
Principles of method if other than guideline:
The method used for testing primary skin irritation was described by J.H. Draize in "Appraisal of the Safety of Chemicals in Foods, Drugs, and Cosmetics", The Association of Food and Drug Officials of the United States, 1975 (pp. 46-48).
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Tetradonium bromide
EC Number:
214-291-9
EC Name:
Tetradonium bromide
Cas Number:
1119-97-7
Molecular formula:
C17H38N.Br
IUPAC Name:
trimethyl(tetradecyl)azanium bromide
Test material form:
solid: particulate/powder
Details on test material:
White powder
Specific details on test material used for the study:
White powder

Test animals

Species:
rabbit
Strain:
other: SPF-Russian strain
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Versuchstierzuchtanstalt WIGA, D-8741 Sulzfeld
- Weight at study initiation: 1600-1750 g
- Housing: Single cages, 45x90 cm with a floor of wire netting
- Diet: free access to feed pellets (green rabbit KFK 7112)
- Water: free access to fresh water
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19±2
- Humidity (%): 50±10

Test system

Type of coverage:
other: 2 layers of gauze, rabbits hereafter wrapped in a plastic-coated cellulose material fastened by tape
Preparation of test site:
other: clipped, half of test sites were scratched by a 18G needle
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g to each test field
- Concentration (if solution): 0.1, 0.5 and 2.5 % (w/w)
Duration of treatment / exposure:
24 hours, treated skin was washed with water and left uncovered 48 hours
Observation period:
24 hours, 72 hours
Number of animals:
9
Details on study design:
TEST SITE
- Area of exposure: 10x15 cm, divided into six fields,
- Type of wrap if used: 2 layers of gauze, rabbits hereafter wrapped in a plastic-coated cellulose material fastened by tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, after 24 hours of exposure
- Time after start of exposure: 24 hours

SCORING SYSTEM: Erythema and eschar; oedema

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: #1, #2, #3
Time point:
other: 24 hours
Score:
0
Max. score:
4
Remarks on result:
other: Intact and scratched, 0.1%
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24 hours
Score:
2
Max. score:
4
Remarks on result:
other: Scratched, 0.5%
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24 hours
Score:
1
Max. score:
4
Remarks on result:
other: Intact and scratched, 0.5%
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24 hours
Score:
0
Max. score:
4
Remarks on result:
other: Intact and scratched, 0.5%
Irritation parameter:
erythema score
Basis:
animal: #7, #8, #9
Time point:
other: 24 hours
Score:
0
Max. score:
4
Remarks on result:
other: Intact and scratched, 2.5%
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 72 hours
Score:
1
Max. score:
4
Remarks on result:
other: Scratched, 0.1 %
Irritation parameter:
erythema score
Basis:
animal: #2, #3
Time point:
other: 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Intact and scratched, 0.1%
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 72 hours
Score:
2
Max. score:
4
Remarks on result:
other: Scratched, 0.5%
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 72 hours
Score:
2
Max. score:
4
Remarks on result:
other: Intact and scratched, 0.5%
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 72 hours
Score:
1
Max. score:
4
Remarks on result:
other: Intact and scratched, 0.5%
Irritation parameter:
erythema score
Basis:
animal: #7, #8
Time point:
other: 72 hours
Score:
3
Max. score:
4
Remarks on result:
other: Intact and scratched, 2.5%
Irritation parameter:
erythema score
Basis:
animal: #9
Time point:
other: 72 hours
Score:
2
Max. score:
4
Remarks on result:
other: Intact and scratched, 2.5%
Irritation parameter:
edema score
Basis:
animal: #1, #2, #3
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Intact and scratched, 0.1%
Irritation parameter:
edema score
Basis:
animal: #4, #5, #6
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: Intact and scratched, 0.5%
Irritation parameter:
edema score
Basis:
animal: #7
Time point:
other: 24 hours
Score:
0
Max. score:
4
Remarks on result:
other: Intact and scratched, 2.5%
Irritation parameter:
edema score
Basis:
animal: #8
Time point:
other: 24 hours
Score:
1
Max. score:
4
Remarks on result:
other: Intact and scratched, 2.5%
Irritation parameter:
edema score
Basis:
animal: #9
Time point:
other: 24 hours
Score:
1
Max. score:
4
Remarks on result:
other: Scratched, 2.5%
Irritation parameter:
edema score
Basis:
animal: #7, #8
Time point:
other: 72 hours
Score:
2
Max. score:
4
Remarks on result:
other: Intact and scratched, 2.5%
Irritation parameter:
edema score
Basis:
animal: 9
Time point:
other: 72 hours
Score:
1
Max. score:
4
Remarks on result:
other: Intact and scratched, 2.5%

Any other information on results incl. tables

Table 1: Scores for primary irritation of cetrimide BP Powder, batch no. 8820

Concentration 0.1% (w/w)

 

Erythema-Eschar observation

Oedema observation

Index

24 hours

72 hours

24 hours

72 hours

 

Rabbit no.

Weight, g

Skin

 

 

 

 

 

361

1650

Intact

Scratched

0

0

0

1

0

0

0

0

0.25

362

1700

Intact

Scratched

0

0

0

0

0

0

0

0

0.00

363

1600

Intact

Scratched

0

0

0

0

0

0

0

0

0.00

Concentration 0.5% (w/w)

364

1650

Intact

Scratched

0

2

1

2

0

0

0

0

1.25

365

1650

Intact

Scratched

1

1

2

2

0

0

0

0

1.5

366

1650

Intact

Scratched

0

0

1

1

0

0

0

0

0.5

Concentration 2.5% (w/w)

367

1750

Intact

Scratched

3

3

3

3

0

0

2

2

4.00

368

1600

Intact

Scratched

3

3

3

3

1

1

2

2

4.50

369

1600

Intact

Scratched

3

3

2

2

0

1

1

1

3.25

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The skin irritant effect of the test substance is investigated at different concentrations on nine albino male rabbits. Accordingly, at 0.1% (w/w) the substance was not a skin irritant, at 0.5% (w/w) the substance was non to mildly irritant, and at 2.5% (w/w) the susbtance was a moderate irritant giving a response complying with the CLP criteria for classification as Skin Irrit. 2.
Executive summary:

The skin irritant effect of the test substance is investigated at different concentrations on nine albino male rabbits. Accordingly, at 0.1% (w/w) the substance was not a skin irritant, at 0.5% (w/w) the substance was non to mildly irritant, and at 2.5% (w/w) the substance was a moderate irritant complying with the CLP criteria for classification as Skin Irrit. 2. A specific concentration limit for classification of 2.5% would be appropriate.