Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 Jan 1986 - 11 Feb 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Reference 2

Reference Type:

secondary source

Title:

Skin irritation and corrosion: Reference Chemicals Data Bank

Author:

ECETOC TF

Year:

1995

Bibliographic source:

ECETOC Technical Report No. 66, MArch 1995, ISSN-0773-8072-66

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)

EC Number:

251-846-4

EC Name:

Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)

Cas Number:

34140-91-5

Molecular formula:

C21H44N2.2C18H34O2

IUPAC Name:

oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)

Test material form:

liquid: viscous

Details on test material:

Chemical registery number : CAS 34140-91-5 / EC 251-846-4
Chemical name : N-[(9Z)-octadec-9-en-1-yl]propane-1,3-diaminium di[(9Z)-octadec-9-enoate

Based on the qualitative and quantitative information on the composition, the sample used are representative of the boundary composition shared and agree by each registrant.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Abbaye de Bellefontaine (49122 Bégrolles en Mauges, France)
- Age at study initiation: not indicated
- Weight at study initiation: mean weigh 2.6 kg
- Housing: individually housed in polystyrene cages 0.35 x O.55 x 0.32 m.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): not stated: The inconing, non recycled air, was filtered by an absolute filter.
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 28 Jan 1986 To: 11 Feb 1986

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: non-exposed left flank served as control

Amount / concentration applied:

0.5 mL on approx. 6 cm2 on right flank animal

Duration of treatment / exposure:

3 animals for 1 hour, and 3 additional animals for 4 hours.
Residual test substance was removed by means of a gauze saturated with sterile pyrogen-free water.

Observation period:

14 days

Number of animals:

3 per exposure duration of 1 hour and 4 hours

Details on study design:

A dose of 0.5 ml was applied to the clipped area 6 cm2 wide of the right flank of each animal. The treated area was then covered with a hydrophilic gauze patch to prevent loss of test substance. The test substance and the gauze patch were held in contact with the skin using a semi-occluslve patch adhesive tape.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(1 hour)

Time point:

24/48/72 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Skin dryness was shown reversible by day 11

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(1 hour)

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Skin dryness was shown reversible by day 13

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(1 hour)

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Skin dryness was shown reversible by day 11

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(1 hour)

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(1 hour)

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 5 days

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(1 hour)

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 7

Irritation parameter:

erythema score

Basis:

animal #4

Remarks:

(4 hours)

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: Skin dryness was shown reversible by day 11

Results 8

Irritation parameter:

erythema score

Basis:

animal #5

Remarks:

(4 hours)

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: Skin dryness was shown reversible by day 11

Results 9

Irritation parameter:

erythema score

Basis:

animal #6

Remarks:

(4 hours)

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

fully reversible within: 5 days

Remarks on result:

other: Skin dryness was shown fully reversible by day 12

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Remarks:

(4 hours)

Time point:

24/48/72 h

Score:

3.3

Max. score:

4

Reversibility:

fully reversible within: 8 days

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Remarks:

(4 hours)

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Remarks:

(4 hours)

Time point:

24/48/72 h

Score:

0.7

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

See scoring table.
The reactions were a bit more marked during the observation period in the animals receiving the test substance during four hours than in those receiving the test substance during one hour.
The report concludes that the test substance INIPOL 002 was considered as irritant however the criteria to classify as skin irritatnt according to CLP regulation (2015) are not satisfied.

Any other information on results incl. tables

 Evaluation of skin reactions

		Observation time after exposure
		hours				days
	Animal no.	1 hr	24 hr	48 hr	72 hr	4	5	6	7	8	9	10	11	12	13
Erythema	01	0	2	2	2	2	2	1A	1A	0A	0A	0A	0	0	-
	02	1	3	3	3	3	3	2A	1A	0A	0A	0A	0A	0A	0
	03	0	1	1	1	1	1	1A	0A	0A	0A	0A	0	0	-
	04	2	2	3	4	4	4A	3A	2A	1A	0A	0A	0	0	-
	05	1	2	2	1	1	1	1A	0A	-	-	-	-	0	-
	06	2	2	2	1	1	1	0A	0A	0A	0A	0A	0A	0	-
Oedema	01	0	1	1	0	0	0	0	0	0	0	0	0	0	-
	02	0	2	2	1	1	1	0	0	0	0	0	0	0	0
	03	0	1	1	1	0	0	0	0	0	0	0	0	0	-
	04	2	3	3	4	4	4	3	2	1	0	0	0	0	-
	05	1	1	1	0	0	0	0	0	0	-	-	-	0	-
	06	0	1	1	0	0	0	0	0	0	0	0	0	0	-

A: Skin dryness

 - : Animals without dermal reaction were not recorded any more.

Animals no. 01, 02, 03: Contact duration 1 hour

Animals no. 04, 05, 06: Contact duration 4 hours

Applicant's summary and conclusion

Interpretation of results:

other: not iclassified according to CLP Criteria

Conclusions:

The test substance was considered as irritant according to ECETOC but not according CLP criteria.

Executive summary:

The acute dermal irritation of the test substance INIPOL 002 was evaluated after application of 0.5 ml on the skin of six New-Zealand white rabbits divided into two groups of three animals. The test substance was removed after one hour in one group and after four hours in the other group by means of a gauze patch saturated with sterile pyrogen-free water.

 

One hour after removal of the gauze patch, the signs of dermal irritation were very weak in the animals receiving the test substance during one hour, and moderate in the other animals.

After 24 hours, the signs of irritation were similar and moderate in both groups. They were marked in one animal on day 3 and day 4.

On day 4 an erythema associated with a severe oedema was observed in one animal, as well as a moderate to severe erythema in one animal, a well defined erythema in one animal, a very slight erythema in three animals, and a very slight oedema in two animals.

Oedema lasted until day 8 in one animal.

The erythema noted on day 4 persisted on day 6, and then had disappeared on day 8 in three animals and on day 9 in the last two animals.

On day 9 only skin dryness was noted in 5/6 animals and over the days was observed in less animals, and completely cleared on day 13.

To sum up, the reactions were a bit more marked during the observation period in the animals receiving the test substance during four hours than in those receiving the test substance during one hour.

Under our experimental conditions, the test substance INIPOL 002 was considered as irritant.

ECETOC (Technical Report 66) evaluated this report and calculated the Primary Irritation Index for the three animals that were exposed for 4 hours:

PII = ( SUM Erythema 24/48/72hr + SUM Oedema 24/48/72hr)/ (3 x no. of animals) = 3.67

However the criteria to classify as skin irritant Cat. 2 according to CLP regulation (2015) are not satisfied.