2,2'-(octylimino)bisethanol

Skin irritation / corrosion

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

Test material information

Constituent 1

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

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Results 2

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

Results 3

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

Results 4

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

Results 5

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

Results 6

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:

Category 2 (irritant) based on GHS criteria

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.