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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
testing of intact and abraded skin; shorter observation period, body weight not recorded.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
The test item was ground to a fine powder before application.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Boyertown (USA)
- Age at study initiation: ca 3 months
- Weight at study initiation: 2.2 - 2.5 kg
- Housing: single caging
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled, no further details
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1997-04-02 To: 1997-02-28

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Remarks:
one side abraded, the other intact
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 g onto intact skin
0.5 g onto abraded skin
(1g per animal total)
Duration of treatment / exposure:
4h
Observation period:
72h
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: back
- Type of wrap if used: surgical gauze patches which secured with non-irritating adhesive tape.

REMOVAL OF TEST SUBSTANCE
Residual test article was removed from the test site by gentle wiping at the end of the exposure period, prior to scoring for dermal reactions.

OBSERVATION TIME POINTS
The wrappings were fitted with a window which was opened to examine the treated sites at 3 minutes and again at 1 hour postdose. At 4 hours the wrappings were removed and the skin reactions were scored at 24, 48 and 72 hours after patch removal.

SCORING SYSTEM:
Scoring was performed based on the Draize system. The Primary Irritation Index was calculated by adding the mean values (3 rabbits) for erythema/eschar and edema on intact and abraded skin at 24 and 72 hours (a total of 8 values) and dividing the sum by 4.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
other: A Modified Primary Irritation Index was calculated using the 24 and 72 hour scores
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: values for both intact and abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
other: values for intact and abraded skin
Irritant / corrosive response data:
There was no erythema or edema noted at any observation period. The modified primary irritation index is 0.
Other effects:
No clinical signs were observed during the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was not irritating to rabbit skin in this study.
Executive summary:

In a primary dermal irritation study with rabbits the test article (0.5 g) was applied to one intact and one abraded site on the clipped back of each rabbit for a total dermal exposure dose of 1.0 g/ rabbit. In order to facilitate dermal observations during the 4 hour exposure period, the wrappings were fitted with a window which was opened to examine the treated sites at 3 minutes and again at 1 hour postdose. At 4 hours the wrappings were removed and the skin reactions were scored at 24, 48 and 72 hours after patch removal. Skin reactions were evaluated by the Draize technique. The skin was also evaluated for ulceration, necrosis, or any evidence of tissue destruction. A Modified Primary Irritation Index was calculated using the 24 and 72 hour scores.There was no erythema or edema noted at any observation period. The modified primary irritation index is 0.