Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)

Cross-reference

Reason / purpose for cross-reference:

data waiving: supporting information

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

01 August 2018 - 02 August 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

2015

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

August 1998

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

May 2008

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Appendix to Director General Notification, No. 12-Nousan-8147. Agricultural Production Bureau, Ministry of Agriculture, Forestry and Fisheries of Japan (JMAFF)

Version / remarks:

November 2000, including the most recent revisions.

Deviations:

no

GLP compliance:

yes

Specific details on test material used for the study:

- No correction was made for the purity/composition of the test item.

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River France, L’Arbresle, France
- Age at study initiation: A young adult animal (approximately 22 weeks old)
- Weight at study initiation: 3942 g
- Housing: individually in a labeled cage with perforated floor
- Diet: pelleted diet for rabbits (Global Diet 2030 Teklad, Mucedola, Milanese, Italy), provided once daily. In addition, hay was available during the study period.
- Water: municipal tap-water, available ad libitum
- Acclimation period: the animal was allowed to acclimate for at least 5 days before commencement of dosing

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 56 to 82%
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 01 August 2018 - 02 August 2018

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

NEGATIVE CONTROL: adjacent areas of the untreated skin

Duration of treatment / exposure:

3 minutes, 1 hour and 4 hours

Observation period:

4 days

Number of animals:

1 male animal (no further animals were treated, after considering the degree of skin reaction observed in the first animal).

Details on study design:

The animal was initially exposed to the test item for 3 minutes to consider whether exposure could be continued humanely. Subsequently, the animal was exposed to a 1-hour and a 4-hour exposure period using an identical procedure but two seperate skin-sites.

TEST SITE
- Area of exposure: dorsal area, 150 square centimeters (10 x 15 cm)
- % coverage: not indicated
- Type of wrap if used: Micropore tape, wrapped around the abdomen and secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: after removing of each dressing, the skin was cleaned with tap water.
- Time after start of exposure: three minutes, one hour and four hours

OBSERVATION TIME POINTS:
- Post dose observations: immediately after removal of the dressing and 1 and 24 hours after test item removal.

SCORING SYSTEM: Draize
- Method of calculation: visual scoring

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

not specified

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24 h

Remarks on result:

not determinable

Remarks:

due to necrosis

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1 h

Score:

4

Max. score:

4

Reversibility:

not specified

Irritant / corrosive response data:

- No severe skin reactions were noted immediately after an exposure period of three minutes or 1 hour and therefore the third bandage was kept on the skin for an exposure of 4 hours. One day after exposure, the 4 hours treatment resulted in an erythema score of 4. Oedema was scored 1 hour after the bandage was removed resulting in a score of 4, oedema could not be scored one day after exposure due to destruction of the skin.
- Full thickness destruction (noted as brown necrosis) was noted for all treated skin areas on the day after dosing.
- Sticky remnants of the test item were present on the 3 minutes treatment site on day 1
- No signs of systemic toxicity during the study period were observed and no mortality occured

Interpretation of results:

Category 1B (corrosive) based on GHS criteria

Remarks:

Category 1B according to Regulation (EC) No 1272/2008.

Conclusions:

Based on the results of an in vivo skin irritation study, performed according to OECD 404 and GLP principles, N-(Oleyl alkyl)-1,3-propanediamine mono oleate is classified as Category 1B (corrosive) according to GHS and Regulation (EC) 1272/2008.

Executive summary:

The possible irritation or corrosion potential of a single dose of Armolube 211 administered to the intact skin of rabbit was evaluated in a primary skin irritation study carried out based on the guidelines described in OECD 404 (2015)/OPPTS 870.2500 (1998)/JMAFF Guidelines (2000). One rabbit was exposed to three samples of 0.5 grams of Oleyl-diamine mono-oleate applied to separate skin-sites on intact, clipped skin using a semi-occlusive dressing. The exposure periods were 3 minutes, 1 hour and 4 hours, respectively. Skin reactions were assessed on the day of dosing (Day 1) and Day 2. Based on the severe skin reactions, no further animals were exposed.

On the day of dosing, up to grade 2 erythema and grade 4 edema was noted for all treated skin sites. Necrosis was noted for all treated skin areas on the day after dosing.

It is concluded that Oleyl-diamine mono-oleate is corrosive to the skin should be classified as skin corrosive Category 1B under GHS. (CLP: Corrosive Category 1B; H314: Causes severe skin burns and eye damage.)