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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
1 (reliable without restriction)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2,2'-(octylimino)bisethanol
EC Number:
239-555-0
EC Name:
2,2'-(octylimino)bisethanol
Cas Number:
15520-05-5
Molecular formula:
C12H27NO2
IUPAC Name:
2-[(2-hydroxyethyl)(octyl)amino]ethan-1-ol
Test material form:
other: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
details on strain: Chbb: NZW (SPF)
origin of strain: Chemisch pharmazeutische Fabrik; Dr. Karl Thomae GmbH, 88400 Biberach; SPF-Zucht
age of testing animals: 3 - 5 month
weigth of the test animals: 3.2 - 3.6 kg

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL of the undiluted test item was applied
Duration of treatment / exposure:
exposure time: 4 hours
Observation period:
The observation and evaluation weas performed after:
1) 30-60 min
2) 24 hours
3) 48 hours
4) 72 hours
5) 7 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 2 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 2 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the findings of this OECD 404 study in New Zealand White rabbits with 4h semi occlusive skin treatment, observed over a period of 7 days, test substance is determined to be skin irritant. 
Executive summary:

Twenty four hours prior to treatment, 25cm2of the dorsal skin was shaved. Only animals with intact skin were used. A plaster containing a cellulose layer of 2.5 x 2.5 cm was fixed on the prepared skin area of each animal. Under this plaster 0.5 mL of the undiluted test item was applied. The area was then fixed by a semi occlusive bandage for a period of 4 hours. At the end of treatment time the remaining residues were carefully deleted from skin with lukewarm water. The assessment was performed 30-60 minutes, 24, 48 and 72 hours after removing of bandage. Due to some findings still available after 72 hours, the observation period was expanded to 7 days for another evaluation. The skin was assessed for erythema-, eschar-formation and edema according to Draize. All other skin changes were noted. 30-60 minutes, 24, 48 and 72 hours after removing of the plaster, slight to mild erythema and slight edema were observed at all animals. The skin appears partly dry, rough and kind of flaky during the observation period. The overall scoring value is 2.3 for erythema-, eschar-formation and 0.5 for edema formation. All findings were reversible within seven days after removal of plaster.

Based on the findings of this OECD 404 study in New Zealand White rabbits with 4h semi occlusive skin treatment, observed over a period of 7 days, test substance is determined to be skin irritant.