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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:
From July 12, 1982 to July 26, 1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Principles of method if other than guideline:
Abraded and intact dorsal skin (previously clipped) of six New-Zealand white rabbits was exposed to 500 mg test substance for 24 h under occlusive conditions. At the end of the exposure period, the treated skin area was cleaned and irritation/corrosion was assessed at 24, 48 and 72 h and at 1 and 2 weeks according to Draize scoring system.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Origin: Nihon Dobutsu Co., Osaka
Body weight: 2.28 - 3.17 kg
Temperature and relative humidity: 24+/-2°C and 60+/-10%, respectively
Lighting time: 12 h daily
Food: CG-3 type (100 g/day)
Water: tap water, ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded or intact
Remarks:
previously clipped
Vehicle:
physiological saline
Amount / concentration applied:
500 mg of the test substance (slightly moistened with physiological saline) on 1 x 1 inch lint patch
Duration of treatment / exposure:
24 h
Observation period:
14 d
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 4x (2.5 x 2.5 cm²) 2 shaved and 2 abraded sites per anmal
- % coverage:
- Type of wrap if used: Blenderm® surgical tape, 3M Co., Saint Paul, U.S.A.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): at the end of exposure period, the patches were removed from the skin and the treated area was wiped to remove the remaining test material.
- Time after start of exposure:24 h

OBSERVATION TIME POINTS
24, 48 and 72 hrs and 1 and 2 weeks after application

SCORING SYSTEM: Skin reactions of erythema and edema were scored 24, 48 and 72 h and 1 and 2 weeks after application according to the Draize scoring system.
- Method of calculation: Primary irritation score= Sum of (Total scores of erythema and edema at 24 and 72 hrs in 2 intact and 2 abraded skins / 8) for all 6 rabbits / 6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
shaved skin
Basis:
mean
Remarks:
of 6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Remarks:
shaved skin
Basis:
mean
Remarks:
of 6 rabbits
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
shaved and abraded skin
Basis:
mean
Remarks:
of 6 rabbits
Time point:
other: 24 and 72 h
Score:
0.17
Max. score:
8
Reversibility:
fully reversible within: 14 d
Irritant / corrosive response data:
The the test material produced very slight erythema and slight edema at 24 hrs after application in one abraded skin patch, any other skin irritant reactions were not observed. The erythema gradually developed into eschar at 3 days, and disappeared within 10 days. The edema have gradually disappeared within 14 days. The primary irritation score was 0.17.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the study conditions, the substance was not considered to be irritating to skin.
Executive summary:

A study was conducted to determine the in vivo skin irritation potential of the substance according to an internal method of the laboratory. Clipped abraded and intact dorsal skin (ca. 1 x 1 inch) of six New-Zealand white rabbits was exposed to 500 mg of the test substance (slightly moistened with physiological saline) for 24 h under occlusive conditions. At the end of the exposure period, the treated skin area was carefully cleaned. Skin irritation/corrosion was assessed at 24, 48 and 72 h as well as at 1 and 2 weeks after bandage removal according to the Draize scoring system. The test substance produced some grade of erythema and eschar and very slight edema at 24 h after application only in one abraded skin. These changes disappeared within 14 d after application. Under the study conditions, the substance was not considered to be irritating to skin (Hosokawa, 1982).