Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
08 - 11 Mar 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted 12th May 1981)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
Version / remarks:
(revised in Nov 1984)
Deviations:
no
Qualifier:
according to
Guideline:
other: Agricultural chemicals, Laws and Regulations Japan, MAFF (1985)
Deviations:
no
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
- Source: Chemisch Pharmazeutische Fabrik, SPF-Zucht, Dr. Karl Thomae GmbH, Biberach, Germany
- Age at study initiation: approximately 3 - 5 months
- Weight at study initiation: 2.4 - 2.5 kg (females)
- Housing: individually in cages
- Diet: ad libitum, Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe) and hay (approx. 15 g daily)
- Water: ad libitum, tap water

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%): 50±20
- Air changes (per hr): fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: polyethylene glycol 400
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 1.43 g/mL

VEHICLE
0.5 g of the test substance were moistened with 0.35 mL polyethylene glycol 400.
Duration of treatment / exposure:
4 h
Observation period:
72 h
reading time points: 30 - 60 min and 24, 48 and 72 h
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 6.25 cm² on the dorsal area of the trunk
- Type of wrap if used: The moistened test substance was applied to a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (Beiersdorf AG, Hamburg, Germany). The plaster was fixed to the prepared skin area and then covered with a semiocclusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed with with warm tap water.
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Remarks:
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:
erythema score
Basis:
mean
Remarks:
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
Irritant / corrosive response data:
The test substance caused no dermal reactions in any of the test animals throughout the observation period.
Other effects:
No clinical signs of systemic toxicity were observed during the observation period.

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