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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

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)
Principles of method if other than guideline:
last observation at 66 hours after removal of the patch instead of at 72 hours
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute Someren, The Netherlands
- Weight at study initiation: 2810 - 3150 g
- Housing: individually in Lurane cages with perforated floors
- Diet: standard diet ( LK01 Hope Farms Woerden) 100 g/d
- Water: tap water ad libitum
- Acclimation period: not defined

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21 °C
- Humidity (%): 55-75%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
other: skin moistened with 0.5 mL water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL: 0.5 mg
Duration of treatment / exposure:
4 hours
Observation period:
66 hours
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: metaline mounted on permeable tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with a water moistened tissue
- Time after start of exposure: at 4 hours

OBSERVATION TIME POINTS: 1, 24, 48 and 66 hours after removal of the dressing

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
other:
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
no irritant effects at any of the observations (score 0)

Any other information on results incl. tables

Animal no

1

2

3

1

24

48

66

1

24

48

66

1

24

48

66

erythema

0

0

0

0

0

0

0

0

0

0

0

0

oedema

0

0

0

0

0

0

0

0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The substance is non-irrtant to the skin
Executive summary:

Three female rabbits were exposed to the substance during 4 hours under semi-occlusion. Examination of the skin for signs of oedema and erythema at 1, 24, 48 and 66 hours after removal of the dressing showed no irritation (all scores 0). The substance is non-irritant to the skin.