Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
due to severe irritation, only two animals were used
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Triisooctylamine
EC Number:
247-092-0
EC Name:
Triisooctylamine
Cas Number:
25549-16-0
Molecular formula:
C24H51N
IUPAC Name:
tris(6-methylheptyl)amine
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.: 0008924462

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories, Netherlands
- Age at study initiation: Approx. 8-9 months
- Weight at study initiation: 3.58 kg – 4.09 kg
- Housing: Single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: Acclimatization for at least 5 days before application

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +- 3
- Humidity (%): 30 – 70
- Air changes (per hr): ca. 10
- 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 skin 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 h
Observation period:
14 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: dorsolateral part of the trunk
- % coverage: 2.5 cm x 2.5 cm)
- Type of wrap if used: The test patch was secured in position with a semi- occlusive dressing (The test item was covered with a test patch (Idealbinde, Pfälzische Verbandstoff-Fabrik, Kaiserslautern) and Fixomull® stretch (adhesive fleece), Beiersdorf AG)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: The test item was removed at the end of the exposure period with Lutrol®** and Lutrol® / water (1 : 1).

SCORING SYSTEM: according to OECD 404 guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
3.2
Reversibility:
not fully reversible within: 14 days
Remarks on result:
other: There was no indication of necrosis at study termination.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
3.5
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.7
Max. score:
4
Reversibility:
not fully reversible within: 14 days

Any other information on results incl. tables

In the first animal well-defined erythema (grade 2) could be noted immediately after removal of the patch until hour 1. From hour 24 until hour 48, moderate erythema (grade 3) was seen in this animal. This finding increased to severe erythema (grade 4) at hour 72 and decreased to moderate erythema (grade 3) from day 7 until day 14. Slight edema (grade 2) was seen immediately after removal of the patch followed by moderate edema (grade 3) at hour 1 and severe edema (grade 4) at hour 24. This finding decreased to moderate edema (grade 3) from hour 48 to hour 72 and to very slight edema (grade 1) from day 7 until day 14. Both erythema and edema were noted beyond the application area over the entire observation period of 14 days. Moreover, blisters beyond the application area and a whitish discolored application area were seen in this animal at hour 48. Crusty as well as eczema-like skin lesions beyond the application area were seen at hour 72, while brownish discolored plaque-like incrustations and eczema-like skin lesions were seen on day 7. On day 14 scaling and incrustations were noted in this animal.

In the second animal well-defined erythema (grade 2) could be noted immediately after removal of the patch until hour 1. From hour 24 until day 14, moderate erythema (grade 3) was seen in this animal. Very slight edema (grade 1) was seen immediately after removal of the patch followed by slight edema (grade 2) at hour 1 and severe edema (grade 4) from hour 24 until hour 48. This finding decreased to moderate edema (grade 3) from hour 72 until day 7. Erythema and edema were noted beyond the application area. Moreover, blisters, bleeding and a whitish discolored application area beyond the application area were seen in this animal at hour 48. Brownish discolored crusty as well as eczema-like skin lesions beyond the application area were seen at hour 72, while

plaque-like incrustations and eczema-like skin lesions were seen on day 7. On day 14 scaling was noted in this animal, while incrustations had fallen off.

The cutaneous reactions were not reversible in the two animals within 14 days after removal of the patch. The first animal still revealed moderate erythema (grade 3) and very slight edema (grade 1) both beyond the application area, scaling and incrustations.

The second animal revealed moderate erythema (grade 3) beyond the application area and scaling. There was no indication of necrosis at study termination.

Mean scores over 24, 48 and 72 hours for each animal were 3.3 and 3.0 for erythema and 3.3 and 3.7 for edema.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria