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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted using OECD guidelines

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Sponsors identification: SR-720
Data received: 15 January 1997
Description: White powder
Storage conditions: ambient temperature (< 25°C) stored under artifical light

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Three rabbits were supplied by David Percival Ltd, Moston, Sandbach, Cheshire UK.
Weight at the start of the experiment: 2.67-3.02 kg; 12-16 weeks old.
After minimum acclimatisation of 5 days each animal was given a number.
The animals were housed individually in suspended metal cages, with free access to drinking water and food.
The animal room was maintained at a temperature of 17-19°C and relative humidity of 45-50%.
The air exchange was approx. 15 changes per hr and the lighting was controlled by a time switch to give 12 hr continous light and 12 hr darkness.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
0.5 gr of test material moistened with 0.5 ml of distilled water was applied
Duration of treatment / exposure:
4 hr
Observation period:
The sites were examined approx. 1, 24, 48 and 72 hr following the removal of the patches.
Number of animals:
3
Details on study design:
On the day before the test each rabbit was clipped free of fur from the dorsal flank area using vetrinary clippers.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 0.5g of test material moistened with o.5 ml of distilled water, was introduced under 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin.
the patch was secured in position with a surgical adhesive tape. To prevent the animals interfering with the patches, the trunk of each rabitt was wrapped in an elastic corset, and the animals were returned to their cages for the duration of the exposed period.
Four hr after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool and soaked in distilled water.
Approx. 1 hr following the removal of the patches and 24, 48 and 72 hr later the test sites were examined for evidance of primary irritation and scored according to the scale from Draze JH (1977).


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #1
Time point:
other: 1, 24, 48 and 72 hr
Score:
0
Remarks on result:
other: Erythema/Eschar formation/Oedema formation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #2
Time point:
other: 1, 24, 48 and 72 hr
Score:
0
Remarks on result:
other: Erythema/Eschar formation/Oedema formation
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal #3
Time point:
other: 1, 24, 48 and 72 hr
Score:
0
Remarks on result:
other: Erythema/Eschar formation/Oedema formation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Executive summary:

Acute dermal irritation study was conducted on New Zealand White rabbits under OECD guideline 404 and EU method B4. A single 4 hr, semi-occluded application of the test material to the intact skin of 3 rabbits produced no evidence of skin irritation. The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.