Octadecanoic acid, 12-hydroxy-, reaction products with decanoic acid and ethylenediamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 28 september 2010 to 10 october 2010

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

: the relative humidity recorded in the animal room was sometimes outside of the target ranges specified in the study plan.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Octadecanamide, 12-hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]- and N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide) and Decanamide, N,N'-1,2-ethanediylbis-

EC Number:

907-495-0

Cas Number:

198028-14-7

Molecular formula:

C90H180N6O9

IUPAC Name:

Reaction mass of Octadecanamide, 12-hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]- and N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide) and Decanamide, N,N'-1,2-ethanediylbis-

Test material form:

solid

Details on test material:

Chemical name : Reaction mass of N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide) and Octadecanamide, 12-hydroxy-N-[2-[(1-oxodecyl)amino]ethyl]- and Decanamide, N,N'-1,2-ethanediylbis-
Chemical registery number : EC 907-495-0 / CAS : 198028-14-7

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- Age at study initiation: 2 to 4 months old
- Weight at study initiation: From 2.2 to 3.5 kg
- Fasting period before study: the animals were fasted during the night before treatment but had free access to water. Food was given back approximately 4 hours after administration of the test item.
- Housing: in polystyrene cages ().
- Diet (e.g. ad libitum): ad libitum (SAFE, Villemoisson, Epinay-sur-Orge, France)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 30 to 70%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h

IN-LIFE DATES: no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: each animal served as its own control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg
The test item was placed on a gauze pad moistened with purified water

Duration of treatment / exposure:

3 minutes, 1 hour or 4 hours

Observation period:

1, 24, 48 and 72 h after removal of the dressing and if relevant, daily until reversibility of reactions.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: dorso-lumbar region
- % coverage: 6 cm²
- Type of wrap if used: gauze pad held by a non-irritating semi-occlusive dressing and a restraining bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): after removal of the dressing, any residual test item was removed using a cotton pad moistened with tap water
- Time after start of exposure: 3 minutes, 1 hour or 4 hours

SCORING SYSTEM: in accordance with the OECD guideline 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

Mean individual score

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

Mean individual scores

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 2 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

Mean individual scores

Time point:

24/48/72 h

Score:

0.3

Max. score:

4

Reversibility:

fully reversible within: 2 days

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

Mean individual scores

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

Mean individual scores

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

Mean individual scores

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

After a 3-minute or 1-hour exposure (one animal), no cutaneous reactions (scores 0 for edema and erythema) were observed.
After a 4-hour exposure (three animals), a very slight erythema (grade 1) was noted in 2 animals within 24h.
Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.3, and 0.3 for erythema and 0.0, 0.0 and 0.0 for edema.

Any other information on results incl. tables

Table 7.3.1/1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test (4 -hour exposure)

Score at time point / Reversibility	Erythema	Edema
	Max. score: 4	Max. score: 4
60 min	0/1/1	0/0/0
24 h	0/1/1	0/0/0
48 h	0/0/0	0/0/0
72 h	0/0/0	0/0/0
Average 24h, 48h, 72h	0.0/0.3/0.3	0.0/0.0/0.0
Reversibility*)	-/c/c	-/-/-
Average time (day) for reversion	-/2/2	-/-/-

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

not skin irritating

Conclusions:

The substance is not classified according to Regulation (EC) No. 1272/2008 and its subsequent amendments on classification, labelling and packaging (CLP) of substances and mixtures.

Executive summary:

In an acute dermal irritation study, the potential of the test substanceto induce skin irritation in New Zealand Whiterabbits was evaluated following a single topical application according to OECD 404 guideline. The study was conducted in compliance with the principles of Good Laboratory Practices.

The test substance was first applied for periods of 3 minutes, 1 hour and 4 hours to a single male New Zealand White rabbit. Since the test item was not severely irritant or corrosive to the skin on the first animal, it was then applied for 4 hours simultaneously to two other animals.A quantity of 500 mg of the test substance was placed on a moistened gauze pad, which was then applied to an area of the skin of approximately 6 cm2of the animals. The gauze pad was held in place by a non-irritation semi-occlusive dressing and a restraining bandage. For each exposure period, cutaneous reactions were evaluated approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.

On completion of the observation period, the animals were used subsequently for the evaluation of the ocular irritation potential of the same test item.

After a 3-minute or 1-hour exposure in the first animal, no cutaneous reactions were observed. After a 4-hour exposure in the three animals, a very slight erythema (grade 1) was noted in two animals within 24 hours. Mean individual scores over 24, 48 and 72 hours were 0.0, 0.3, and 0.3 for erythema and 0.0, 0.0 and 0.0 for edema.

It was concluded that the test item was slightly irritant when applied topically to skin.