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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:
1997-11-19 to 1997-12-1
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Version / remarks:
1992
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Chesire, UK
- Age at study initiation: twelve to sixteen weeks
- Weight at study initiation: 2.51 to 2.70 kg
- Housing: individually in supended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 20
- Humidity (%): 50 to 65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- Amount applied: 0.5 mL


Duration of treatment / exposure:
3 minutes, 1 hour and 4 hours
Observation period:
1, 24, 48 and 72 hours following the removal of the patches
Number of animals:
Three (one female, two males)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap: a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm x 4.0 cm); the trunk was wrapped in a elasticated corset (TURBIGRIP)

REMOVAL OF TEST SUBSTANCE
- Washing: swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 3 minute, 1 hour and 4 hours

OBSERVATION TIME POINTS
1 hour following the removal of patches, and 24, 48 and 72 hours later

SCORING SYSTEM:
- Method of calculation: Draize scoring system (1977)

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:
4-hour exposure period:
No erythema/eschar and oedema observed at observation times >= 24 h. All treated skin sites appeared normal at the 24-hour observation. Very slight erythema (individual score of 1) and very slight oedema (individual score of 1) were noted at two treated skin sites at the 1-hour observation. This effect was fully reversible within 24 hours. No corrosive effects were noted.

3-minute and 1-hour exposure period:
No evidence of skin irritation was noted during the study. No corrosive effects were noted.


Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material, TODI, is considerd to be not irritating to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404.

A single 4 -hour, semi-occluded application of the test material to the intact skin of three rabbits produces very slight erythema and very slight oedema at two treated skin sites. All treated skin sites appreared normal at the 24 -, 48- and 72-hour observations. No corrosive effects were noted. 3 -minute and 1 -hour semi-occluded applications of the test material to the intact skin of one rabbit procued no corrosive effects. According to the results, the test material has no irritation and no corrosion potential.