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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:
2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline confirmed study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS New Zealand White rabbits
- Source: Myrtle's Rabbitry, Thompson Station, TN
- Age at study initiation: adult
- Weight at study initiation: not mentioned
- Housing: housed individually in suspended stainless steel cages
- Diet (e.g. ad libitum): PMI Certified Rabbit Chow ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 33-35
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: 6.-10.3.2000

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5 g, 100%
Duration of treatment / exposure:
4h
Observation period:
72h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk
- % coverage: /
- Type of wrap if used: elastic wrap was then further secured with adhesive tape around the trunk at the cranial and caudal ends

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gauze moistened with deionized water followed by dry gauze.
- Time after start of exposure: 4h

Dermal Observations
Animals were examined for signs of erythema and edema and the responses scored 1 hour after patch removal and at approximately 24, 48 and 72 hours after patch application according to the Macroscopic Dermal Grading System which is based on Draize.

Clinical Observations
Any unusual observations and/or mortality were recorded. General health/mortality checks were performed twice daily (in the morning and in the
afternoon).

Body Weights
Individual body weights were obtained for each animal priorto dosing on day 0 and prior to euthanasia.

Gross Necropsy
Each animal was euthanized by an intravenous injection of sodium pentobarbital following its final scoring interval. Gross necropsy examinations were not required for these animals.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: all time points
Score:
0.1
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: all time points
Score:
0
Max. score:
4

Applicant's summary and conclusion

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

The potential irritant and/or corrosive effects of the test substance were evaluated on the skin of New Zealand White rabbits. Each of three rabbits received a 0.50 g dose of the test article as a single dermal application. The test article was moistened with deionized water to enhance test article contact with the skin. The dose was held in contact with the skin under a semi-occlusive binder for an exposure period of four hours. Following the exposure period, the binder was removed and the remaining test article was wiped from the skin using gauze moistened with deionized water followed by dry gauze. Test sites were subsequently examined and scored for dermal irritation for up to 72 hours following patch application. Exposure to the test article produced very slight erythema on 3/3 test sites at the 1 -hour scoring interval. The dermal irritation resolved completely on all test sites by the 48-hour scoring interval.