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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-[(1R)-1-hydroxy-2-(methylamino)ethyl]phenol
Cas Number:
59-42-7
Molecular formula:
C9-H13-N-O2
IUPAC Name:
3-[(1R)-1-hydroxy-2-(methylamino)ethyl]phenol
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals or test system 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.