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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: BASF method (Draize test) similar to OECD 404; non-GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
Method: Draize Test according to Fed. Reg. 38, No. 187, Para. 1500.41, p. 27019; Sept. 27, 1973
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ephedrine hydrochloride
EC Number:
200-074-6
EC Name:
Ephedrine hydrochloride
Cas Number:
50-98-6
Molecular formula:
C10H15NO.ClH
IUPAC Name:
2-(methylamino)-1-phenylpropan-1-ol hydrochloride
Constituent 2
Reference substance name:
(-)-Ephedrin Hydrochlorid
IUPAC Name:
(-)-Ephedrin Hydrochlorid
Details on test material:
- name of the test substance: (-)-Ephedrin-Hydrochlorid
- substance number: 80/198
- Expiration date of the lot/batch: june 1982

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: irma Gaukler 6050 Offenbach / Main
- Weight at study initiation: mean weight males: 2.89 kg; mean weight females: 2.69 kg.
- Housing: in single cages
- Diet (ad libitum): Ovator Solikanin 4 MM; Muskator-Werke, 4000 Duesseldorf-1; about 130 g/day
- Water (ad libitum): 250 mL of aqua dest./day
- Acclimation period: about 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 26
- Humidity (%): 50-80
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
water
Controls:
other: untreated skin of the same animals
Amount / concentration applied:
0.5 mL of a 50 % aquaeous solution
Duration of treatment / exposure:
24 hour(s)
Observation period:
8 days
Number of animals:
6 (4 males, 2 females)
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing: with warm water
- Time after start of exposure: 24 h

SCORING SYSTEM: according to Draize: Appraisal of the safety of chemicals in foods, drugs and cosmetics. In dermal toxicology, p. 46-59, 1959. Austin, Texas:

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 2 - 2 - 1
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 1 - 1 - 1
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 1 - 1 - 0
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24 - 48 - 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 1 - 1 - 0
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
other: 24 - 48 - 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 2 - 2 - 2
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
other: 24 - 48 - 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 2 - 2 - 1
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
1.3
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 2 - 1 - 0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: individual scores: 0 - 0 - 0
Irritation parameter:
edema score
Basis:
animal #5
Time point:
other: 24 - 48 - 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 2 - 2 - 1
Irritation parameter:
edema score
Basis:
animal #6
Time point:
other: 24 - 48 - 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
other: individual scores: 1 - 1 - 0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
0.6
Max. score:
4

Any other information on results incl. tables

In an pre-test two animals each were treated with the test substance for 3 minutes and 2 h, respectively. Except a slight erythema in the 24 -h reading only in one animal exposed for 2 h, no effects were observed at either time point in all animals treated.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU