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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
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): AE 0001789
- Analytical purity: 97.4 %
- Lot/batch No.: 08466/0013

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, 88353 KiBlegg, Germany
- Age at study initiation: young adults (actual ages not stated)
- Weight at study initiation: 2.9 kg - 3.8 kg
- Housing: individually in cage units Metall/Noryl by EBECO. Excrement trays below the cages contained low dust wood granulate bedding.
- Diet: standard diet "Ssniff K-Z" 4mm (manufacturer: Ssniff Spezialdiaten GmbH, Soest, Germany), approx. 100 g/animal/day, ad libitum.
- Water: tap water from polycarbonate bottles, ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 55 ± 20
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From 2004-11-02 To 2004- 11-05

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated dorsolateral skin site of same animal served as control
Amount / concentration applied:
0.5 g
Duration of treatment / exposure:
Initial test (1 animal): 3 min, 1 and 4 h.
Confrimatory test (2 animals): 4 h
Observation period:
72 h
Reading time points: 1, 24, 48 and 72 h after patch removal.
Number of animals:
3 females
Details on study design:
-TEST SITE: On the day before the test, the fur was shorn on the right and left side from the dorso-lateral area of the trunk of each of the rabbits avoiding abrasion of skin and only animals with intact skin were used.
- Application of the test substance: 0.5 g of the pulverized test substance moistened with water (to ensure good contact with the skin) was applied to the shaven dorsolateral skin of the animal under a gauze patch of approximately 2.5 cm by 2.5 cm in size and held in place with non-irritating tape
for the duration of the exposure period of up to 4 h.
-Removal of Test substance: Dressing and patch were removed after up to 4 h exposure period, the exposed skin carefully washed and the treated
skin site was scored.
SCORING SYSTEM: scored for erythema and oedema in accordance with Draize system as in OECD 404 guideline (2002) and contralateral untreated skin served as control.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: mean out of all 3 animals
Time point:
other: mean over 24, 48, and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
edema score
Basis:
animal: mean out of all 3 animals
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
No evidence of skin irritation was observed
Other effects:
No treatment-related signs of toxicity.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified

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