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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:
01 Feb - 08- Feb 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): PRIFRAC 2922
- Physical state: solid
- Analytical purity: not given
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren / The Netherlands (SPF-Quality)
- Age at study initiation: 13 weeks
- Weight at study initiation: 2427 - 2547 g
- Housing: individually in cages with perforated floors equipped with an automatic drinking system (ITL, Bergen / The Netherlands).
- Diet: standard laboratory rabbit diet (LKK-20, pellet diameter 4 mm, Hope Farms, Woerden / The Netherlands); approx. 100 g / day.
- Water (ad libitum): free access to tap-water diluted with decalcified water
- Acclimation period: at least five days under test conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): air-conditioned with 7.5 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
other: untreated skin sites of same animals
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
4 hours
Observation period:
8 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 10 cm x 10 cm
- Type of wrap if used: the dressing was wrapped around the abdomen and secured with an elastic bandage.


REMOVAL OF TEST SUBSTANCE
- Washing: Four hours after the application, the dressing was removed and the remaining test substance was removed using a dry tissue and subsequently a tissue moistened with tap water.


CORING SYSTEM:
Erythema:
0 - no erythema
1 - very slight erythema (barely perceptible)
2 - well-defined erythema
3 - moderate to severe erythema
4 - severe erythema (beet redness) to slight eschar formation (injuries in deep)

Edema:
0 - no edema
1- very slight edema (barely perceptible)
2 - slight edema (edges of area well defined by definite raising)
3 - moderate edema (raised appr. 1 mm)
4 - severe edema (raised >1 mm and extending beyond area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
The observed skin irritation consisted of very slight erythema. The irritation was reversible in one animal within 24 hours, in the second animal within 48 hours and in the third animal within 7 days after exposure.
No corrosive effect was evident on the skin.

Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Readings:

Time Animal Erythema Edema Other findings
1 h 1 1 0
2 1 0
3 1 0
24 h 1 1 0  +/- 50% of exposed area
2 0 0
3 1 0  +/- 50% of exposed area
48 h 1 1 0  +/- 50% of exposed area
2 0 0
3 0 0
72 h 1 1 0  +/- 5% of exposed area
2 0 0
3 0 0
7 d 1 0 0
2 0 0
3 0 0
mean 24 - 48 - 72 h 1 1.0 0.0
2 0.0 0.0
3 0.3 0.0
mean 0.4 0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU