C16-18-(even numbered)-alkyl fatty acid, compound with C16-18-(even numbered)-alkylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

19 December 2012 - 21 January 2013

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Compliant to GLP and testing guidelines; adequate consistence between data, comments and conclusions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

C16-18-(even numbered)-alkyl fatty acid, compound with C16-18-(even numbered)-alkylamine

EC Number:

800-984-9

Cas Number:

1428547-35-6

Molecular formula:

RNH3+, R’COO- where R = C16-18-alkyl and R' = C15-17-alkyl

IUPAC Name:

C16-18-(even numbered)-alkyl fatty acid, compound with C16-18-(even numbered)-alkylamine

Test material form:

other: solid

Details on test material:

- Other name: N-(hydrogenated tallow alkyl) amine, N-(hydrogenated tallow alkyl) fatty acid salt without free fatty acid
- Physical state: light yellow solid
- CAS number : 68551-29-1
- Batch number: EP 4756
- Analytical purity: 100%
- Expiry date: 10 January 2015
- Storage condition: at room temperature.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeder: CEGAV, Argenvilliers, France
- Age at study initiation: 2 to 4 months old on the day of treatment
- Mean body weight at study initiation: 2822 g (range: 2655 g to 3105 g)
- Fasting period before study: no
- Housing: individually housed in noryl cages
- Diet: 110 pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: at least 5 days before the beginning of the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h.

IN-LIFE DATES: 08 January 2013 to 21 January 2013.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g/flank

Duration of treatment / exposure:

3 min, 1 h, 4 h.

Observation period:

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

Number of animals:

Three males.

Details on study design:

TEST SITE
- Area of exposure: the test item was placed on a gauze pad, moistened with drinking water treated by reverse osmosis, which was then applied to a skin area of approximately 6 cm2.
During each exposure time, a dry gauze pad was applied to the opposite flank, in order to check that no alteration of the skin is induced by the semi-occlusive dressing and restraining bandage.
The untreated flank acted as control.
The gauze pad was held in place by a non-irritating semi-occlusive dressing and a restraining bandage. After required period of contact with the skin, the dressing was removed.
After removal of the dressing, any residual test item was wiped off by means of a moistened cotton pad with drinking water treated by reverse osmosis.
- Type of wrap if used: gauze pad held in place by a non-irritation semi-occlusive dressing and a restraining bandage.

REMOVAL OF TEST SUBSTANCE
- Washing: using a dry cotton pad
- Time after start of exposure: at removal of each dressing (see Duration of exposure)

SCORING SYSTEM:

- Erythema and eschar formation:
0 no erythema
1 very slight erythema (barely perceptible)
2 well-defined erythema
3 moderate to severe erythema
4 severe erythema (beet redness) to slight eschar formation (injuries in depth)

- Edema formation:
0 no edema
1 very slight edema (barely perceptible)
2 slight edema (edges of area well-defined by definite raising)
3 moderate edema (raised approximately 1 millimeter)
4 severe edema (raised more than 1 millimeter and extending beyond area of exposure)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48, 72 h (mean)

Score:

1

Max. score:

1

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48, 72 h (mean)

Score:

0

Max. score:

0

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48, 72 h (mean)

Score:

0.3

Max. score:

1

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48, 72 h (mean)

Score:

0

Max. score:

0

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48, 72 h (mean)

Score:

1

Max. score:

2

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24, 48, 72 h (mean)

Score:

0

Max. score:

0

Other effects:

After a 3-minute exposure in 1/3 animals, dryness of the skin was observed on day 2.
After a 4-hour exposure, dryness of the skin was recorded from day 6 to day 8 in 1/3 animals and on day 4 in 1/3 animals.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP Regulation

Conclusions:

The test item was slightly irritant when applied topically to rabbits.
However, the test item should not be classified as irritating to skin according to the criteria of CLP Regulation.

Executive summary:

The objective of this study was to evaluate the potential corrosive and irritant properties of the test item following dermal application on rabbits.

 

Methods

The test item was first applied for periods of 3 minutes, 1 hour and 4 hours to a single male New Zealand White rabbit.

After the 4-hour application, since the mean value from grading at 24, 48 and 72 hours after patch removal was < 2.3 for erythema and for edema, the test item was applied on the skin of two other animals for 4 hours.

 

A quantity of 0.5 g/flank was used.

The test item was placed on a gauze pad, moistened with drinking water treated by reverse osmosis, which was then applied to a skin area of approximately 6 cm². The gauze pad was held in place by a non-irritating semi-occlusive dressing and a restraining bandage. After the required period of contact with the skin, the dressing was removed.

Each animal was observed once a day for mortality and clinical signs. For each exposure period, cutaneous reactions were evaluated approximately 1 hour, 24, 48 and 72 hours after removal of the dressing and then daily until the reversibility of cutaneous reactions. The mean values of the scores for erythema and edema were calculated for each animal. Body weight was recorded on the day of treatment and at the end of the evaluation of cutaneous reactions.

On completion of the observation period, the animals were sacrificed then discarded without macroscopic post-mortem examination.

Results

No unscheduled deaths occurred during the study and no clinical signs were noted in any animals.

The body weight of the animals was unaffected by the test item treatment.

After a 4-hour exposure, a very slight or well-defined erythema was noted in all animals from day 1 until day 2, 4 or 5.

 

Dryness of the skin was recorded in one animal between day 6 and day 9 and in another animal on day 4.

 

Mean scores calculated for each animal over 24, 48 and 72 hours were as follows:

.          erythema: 1.0, 0.3, 1.0; showing no significant inflammation,

.          edema: 0.0, 0.0; 0.0; showing no significant inflammation.

 

Conclusion

The test item was slightly irritant when applied topically to rabbits.

However, the test item should not be classified as irritating to skin according to the criteria of CLP Regulation.