Oleic acid, compound with N-(2-aminoethyl)ethane-1,2-diamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline Study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

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:

Oleic acid, compound with N-(2-aminoethyl)ethane-1,2-diamine

EC Number:

241-924-6

EC Name:

Oleic acid, compound with N-(2-aminoethyl)ethane-1,2-diamine

Cas Number:

18016-43-8

Molecular formula:

C38H69N3O – C58H111N3O3

IUPAC Name:

(9Z)-octadec-9-enoic acid; bis(2-aminoethyl)amine

Details on test material:

- Name of test material (as cited in study report): Oleic acid, compound with N-(2- aminoethyl)ethane-1,2-diamine
- Physical state: liquid
- Analytical purity: Reaction product of Oleic acid and N-(2-aminoethyl) ethane-1,2-diamine: elemental analysis yielded 100.4 g/100 g; "Triamide"-content: 5.2 g/100 g (HPLC analysis)
- Storage condition of test material: room temperature

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: Approx. 5-7 months
- Weight at study initiation: 4.05 kg – 4.92 kg
- Housing: Single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 30 – 70%
- Air changes (per hr): Approx. 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 hours

Observation period:

14 days

Number of animals:

3

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: semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test item was removed at the end of the exposure period with Lutrol®** and Lutrol® / water (1 : 1).
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD 404 guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

2.9

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: necrosis was not observed, individual mean scores: 2.7 in 1/3 animals, 3.0 in 2/3 animals

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24/48/72 hours

Score:

4

Reversibility:

not fully reversible within: 14 days

Remarks on result:

other: mean individual scores: 4 in 3/3 animals

Any other information on results incl. tables

In two out of three animals well-defined erythema (grade 2) was observed directly after removal of the patch and increased to moderate erythema (grade 3) in one of these animals after one hour. From 24 hours until day 7 moderate erythema was noted in

these two animals and decreased to well-defined (grade 2) or very slight (grade 1) erythema at day 14, respectively. In the third animal well-defined erythema was observed from 1 hour until 24 hours after removal of the patch; thereafter moderate

erythema was noted from 48 hours until study day 7 and decreased to well-defined erythema at day 14. In all three animals erythema was noted beyond the application site from 24 hours until study day 7 or 14, respectively.

In one animal slight edema (grade 2) was noted directly after removal of the patch; one hour later slight edema was still observed in this animal. The other two animals showed very slight (grade 1) or severe (grade 4) edema 1 hour after removal of the patch. 24

hours after removal of the patch severe edema was noted in all animals and persisted until 72 hours in two animals or study day 7 in one animal. In two out of three animals slight or moderate edema was noted on study day 7; in one of these animals very slight

edema was still observed on study day 14. The third animal also showed very slight edema on study day 14. In two out of three animals edema beyond the application site was noted from hour 24 until day 7.

Yellowish or brown-yellowish discoloration of the application area was noted in all animals from 24 hours until 72 hours after removal of the patch. In two out of three animals crusty secretion was also seen during this observation period; while plate-like

incrustations were noted in all three animals at 72 hours or on study day 7, respectively. Thereafter, on day 7 or day 14 the plate-like incrustations dropped off and revealed underneath either petechiae and scaling or pink-colored skin with or without

scaling. In one of these animals scaling was noted during the whole observation period (except day 7) until day 14.

The cutaneous reactions were not reversible in all three animals within 14 days after removal of the patch. Slight or well-defined erythema and/or very slight edema were still present at study termination, in one animal in addition to scaling.

Necrosis of the skin was not evident during the course of the study.

Mean scores over 24, 48 and 72 hours for each animal were 3.0, 3.0 and 2.7 for erythema and 4.0, 4.0 and 4.0 for edema.

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU