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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, similar to guideline study, minor restrictions in design and/or reporting buth otherwise adequate for assessment

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)
Deviations:
yes
Remarks:
, occlusive conditions
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
299-43-3
IUPAC Name:
299-43-3
Details on test material:
- Name of test material (as cited in study report): (-)-ephedrin, wasserhaltig

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler 6050 Offenbach/Main
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: 1 animal per cage, stainless steel cage with wire mesh flooring, floor space: 40 cm x 51 cm, no bedding in cages, sawdust in the waste trays.
- Diet: 130 g per animal per day, Ovator Solikanin 4MM; Muskator-Werke 4000 Dusseldorf
- Water: 250 mL per animal, demineralized water on workdays, and 250 mL per animal tap water on free days
- Acclimation period: ca. 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:
shaved
Vehicle:
water
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: the test patch is covered with an about 0.5 mm layer of the suspension (about 0.5 g)
- Concentration: 50% aqueous solution
Duration of treatment / exposure:
- Group 1: 3 min
- Group 2: 1 hour
Observation period:
8 days
Number of animals:
- Group 1: 2
- Group 2: 4
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm of upper third part of the back

REMOVAL OF TEST SUBSTANCE
- Washing with lutrol and lutrol/water (1:1)
- Time after start of exposure: after 3 min or 1 hour

SCORING SYSTEM:
- According Draize J.H. et al. (1959)
- Scoring performed 15-30 min, 24, 48, and 8 days after removal of the test substance

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
0
Max. score:
4
Remarks on result:
other: 3 min exposure
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 48 h
Score:
0
Max. score:
4
Remarks on result:
other: 3 min exposure
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 - 48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 h exposure
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24 - 48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 h exposure
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 - 48 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 h exposure
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24 - 48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 h exposure
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 - 48 h
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 h exposure: No observation at timepoint 24 and 48 hours because of substance-related coloring of the skin
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24 - 48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 h exposure
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
other: 24 - 48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 h exposure
Irritation parameter:
edema score
Basis:
animal #4
Time point:
other: 24 - 48 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 1 h exposure
Irritant / corrosive response data:
In 3 out of 4 animals redness and edema was observed 24 and 48 hours after exposure. In 2 out of 4 animals haemorrhagic crustae were visible 24 hours after exposure. In 1 animal necrosis was also observed 24 and 48 hours after exposure. Necorisis was observed in all animals 8 days after exposure.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Conclusions:
Under the conditions of the test, the substance is considered to be corrosive to the skin after an exposure period of one hour.
Executive summary:

The potential to cause acute dermal irritation or corrosion was assessed in a similar to OECD 404 guideline study by a single topical application of 0.5 g for 3 minutes or 1 hour to the intact skin of 2 or 4 Vienna White rabbits, respectively, using a patch of 2.5 cm x 2.5 cm, covered with occlusive dressing. After removal of the patch, the application area was washed off with lutrol and lutrol/water (1:1). The cutaneous reactions were assessed immediately after removal of the patch and approximately 24 and 48 hours, and 8 days after removal. In animals exposed for 3 min no effects were observed. In 3 out of 4 animals exposed for 1 hour redness and edema was observed 24 and 48 hours after exposure. Haemorrhagic crustae were also visible in 2 out of 4 animals at the 24 hours after exposure. Necrosis was observed in all animals 8 days after exposure. It was concluded that the test substance was corrosive.