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
Study period:
1986-01-13
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1981
Deviations:
no
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
- Source: Nottingham University, School of Agriculture, Sutton Bonington, Leicestershire, U. K.
- Age at study initiation: approx. 12 to 16 weeks
- Weight at study initiation: 2.30 - 2.59 kg
- Housing: The animals were individually housed in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: min 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 21 °C
- Humidity: 45 - 60 %
- Air changes: approx. 15 per hr
- Photoperiod: 12 / 12hrs dark / hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
Approximately one hour following removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of prirnary irritation and scored.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure:
dorsal flank area
- % coverage:
2.5 cm x 2.5 cm gauze patch, whole trunk wrapped
- Type of wrap:
adhesive strapping (SLEEK) wrapped with elasticated corset (TUBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing:
gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure:
4 h

OBSERVATION TIME POINTS
: Approximately one hour following removal of the patches, and 24, 48 and 72 hours later.

SCORING SYSTEM:
- Method of calculation: Draize J.H. (1959) Association of Food and Drug 0ffi ci al s of the Uni ted States, Austi n, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No signs of skin irritation were noted during the study period. The test material was therefore considered as non irritant.

Any other information on results incl. tables

Table 1 Individual daily and individual mean scores for dermal irritation/corrosion

Animal no

Time after treatment

Erythrema/Eschar

Oedema Formation

1

1

0

0

24

0

0

48

0

0

72

0

0

Total 24, 48, 72 h

0.0

0.0

2

1

0

0

24

0

0

48

0

0

72

0

0

Total 24, 48, 72 h

0.0

0.0

3

1

0

0

24

0

0

48

0

0

72

0

0

Total 24, 48, 72 h

0.0

0.0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was found to be non-irritant to the rabbit skin under the conditions of this study.
Executive summary:

The study was carried out in order to assess the irritancy potential of a test material following a single 4-hour semi-occluded application to the intact rabbit skin. The study was designed to comply with the recommendations of the OECD Guidelines for Testing of Chemicals (1981) No.404 "Acute Dermal Irritation/Corrosion". The test system was chosen because the rabbit has been shown to be a suitable model for this type of study and is recommended by the test method. Three New Zealand White rabbits were exposed to the test item on the clipped skin under semiocclusive dressing. After 4 h the test item was removed by gentle washing. Skin was inspected for local irritaion symptons directly after removing the test item and after 24, 48, and 72 h. No signs of skin irritation were noted during the study period. Therefore, the test item is considered to be not irritating to rabbit skin.