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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2003-04-14 to 2003-05-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study OECD 404; no GLP compliance statement.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Covance Research Products, Denver, Pennsylvania
- Age at study initiation: young adult
- Housing: The rabbits were housed singly in stainless steel, wire-mesh cages suspended above cage boards.
- Diet: approximately 125 grams of PMI® Nutrition International, LLC Certified High Fiber Rabbit LabDiet® 5325 daily during the study
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50 +/- 10
- Photoperiod: 12-hour light/12-hour dark cycle

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped skin on the back
Vehicle:
water
Controls:
not specified
Amount / concentration applied:
0.5g, moistened with deionised water
Duration of treatment / exposure:
4 hours
Observation period:
1, 24 and 48 hours after removal
Number of animals:
3 males
Details on study design:
Four separate, localised test sites (approximately 6 cm² each) were marked on each rabbit's back with a water-insoluble marker. Approximately 0.5 g of each test substance, moistened with approximately 0.2 or 0.3 mL of deionised water to form a thick paste, was applied to the designated test site and covered with a 2-ply, 1-inch square gauze pad. The pad was held in place with non-irritating tape. Removal of the test substance with warm water and soap. Observation of clinical signs. Measuring of body weight. Scoring after Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1-48 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: all tested substances
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1-48 hours
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
other: all tested substances
Irritant / corrosive response data:
No dermal irritation in any of the rabbits during the study. Test sites treated with test items 1, 2 and 3 were stained by the test substance.
Other effects:
No clinical signs, no body weight loss.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the criteria specified by Directive 67/548/EC and subsequent regulations none of the four test items is a skin irritant and therefore no classification is required.