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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: OECD guideline study, with acceptable restrictions (no data on test substance purity)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted 1981)
Deviations:
yes
Remarks:
(test design not in accordance with sequential testing strategy as laid down in the Supplement of the recent version of the OECD TG 404 (2002))
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trioctylamine
EC Number:
214-242-1
EC Name:
Trioctylamine
Cas Number:
1116-76-3
Molecular formula:
C24H51N
IUPAC Name:
N,N-dioctyloctan-1-amine
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Tri-N-Octylamine
- Analytical purity: no data
- Impurities (identity and concentrations): no data

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach, Germany
- Age at study initiation: no data
- Weight at study initiation: male rabbits (mean): 2.63 kg; female rabbit 2.87 kg
- Housing: single
- Diet (ad libitum): Kliba 341, 4 mm, Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland (about 130 g per animal per day)
- Water (ad libitum): tap water (about 250 mL per animal per day)
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated dorsal skin sites of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL


Duration of treatment / exposure:
4 hours
Observation period:
15 days
Number of animals:
3 animals (2 males, one female)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm, upper third of the back or flanks
- Type of wrap: test patches were secured in position with a porous dressing (4 layers of absorbent gauze and porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with lutrol and lutrol/water (1:1)
- Time after start of exposure: 4 hrs

SCORING SYSTEM: Draize scoring system

READINGS:
Readings of skin reactions were performed 30 - 60 min after removal of the test patches and then 24 h, 48 h, 72 h, 8 d, and 15 d after the beginning of application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
3.7
Max. score:
4
Reversibility:
not fully reversible within: 15 days
Remarks on result:
other: Erythema and scaling beyond the area of application at study termination
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: Scaling beyond area of application at study termination
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
3.7
Max. score:
4
Reversibility:
fully reversible within: 15 days
Remarks on result:
other: Scaling at study termination
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24-48-72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24-48-72 h
Score:
2.7
Max. score:
4
Reversibility:
fully reversible within: 15 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24-48-72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 15 days

Any other information on results incl. tables

Results:

Readings

Animal No.

Erythema

Edema

Additional findings

4 h

1

2

0

-

2

2

1

-

3

2

1

-

24 h

1

3

4

findings (ery., ed.) extending beyond the area of application

2

4

3

findings (ery., ed.) extending beyond the area of application

3

3

3

findings (ery., ed.) extending beyond the area of application

48 h

1

4

3

findings (ery., ed.) extending beyond the area of application

2

4

3

findings (ery., ed.) extending beyond the area of application

3

4

2

findings (ery., ed.) extending beyond the area of application

72 h

1

4

2

findings (ery., ed.) extending beyond the area of application

2

4

2

findings (ery., ed.) extending beyond the area of application

3

4

1

findings (ery., ed.) extending beyond the area of application

8 d

1

2

2

findings (ery., ed.) extending beyond the area of application, superficial scabbing extending beyond the area of exposure, hemorrhage

2

2

1

findings (ery., ed.) extending beyond the area of application, superficial scabbing extending beyond the area of exposure

3

2

1

findings (ery., ed.) extending beyond the area of application, superficial scabbing extending beyond the area of exposure

15 d

1

1

0

findings (ery., scaling) extending beyond the area of application

2

0

0

findings (scaling) extending beyond the area of application

3

0

0

scaling

mean (24 - 48 - 72 h readings)

1

3.7

3.0

n.a.

2

4.0

2.7

n.a.

3

3.7

2.0

n.a.

n.a.: not applicable

ery.: erythema

ed.: edema

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU