Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Fa. Thomae , Biberach
- Age at study initiation: 24 - 28 weeks
- Weight at study initiation: 2.1 - 2.4 kg
- Housing: Individually housed
- Diet (e.g. ad libitum): Rabbit breeding feed 9970 S Fa. Altromin
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 - 26
- Humidity (%): 50 - 65
- Photoperiod (hrs dark / hrs light): 12 : 12

Test system

Type of coverage:
other: occulsive and semiocculsive
Preparation of test site:
shaved
Vehicle:
physiological saline
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
1 week
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: 3 cm x 3 cm
- Type of wrap if used: gauze patch

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 4h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: all animals
Time point:
other: 1 hour - 7 days
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: all animals
Time point:
other: 1 hour - 7 days
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of this study, (-)- Phenylephrinbase was non-irritating / non-corrosive to the skin of the rabbits.