N-(3-ammoniopropyl)-N-[C16-C18, C18 unsatured]alkylpropane-1,3-diaminium triacetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

July-August 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Limited reported study comparable to guideline/standard.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

tested during 3, 30, 60 and 240 min; occlusive exposure rather than semi-occlusive

GLP compliance:

yes

Remarks:

audited in house

Test material

Test material information

Constituent 1

Reference substance name:

Amines, N-(3-aminopropyl)-N-tallow alkyltrimethylenedi-

EC Number:

288-048-0

EC Name:

Amines, N-(3-aminopropyl)-N-tallow alkyltrimethylenedi-

Cas Number:

85632-63-9

IUPAC Name:

85632-63-9

Details on test material:

Name of test compound: LILAMIN LS 33
(Description Lilamin LS 33: See endpoint 7.2.1. "85632-63-9, Acute toxicity: oral, Kynoch, 1985, RS"
Appearance: brown/yellow liquid
Date of receipt: 4 December 1984
Storage: ambient temperature
Composition:
60-65% tallow alkyl dipropylene triamine
25-30% tallow diamine
5-10% ditallow alkyl propylene diamine

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Rosemead Rabbits, Rosemead, UK and Morton Commercial Rabbits, Stansted, UK
- Age at study initiation: 9-14 weeks
- Weight at study initiation: 1.9-3.2 kg
- Housing: individually in metal cages with perforated floor
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: yes but no further info


ENVIRONMENTAL CONDITIONS
- Temperature (°C): ca. 19
- Humidity (%): 30-70
- Air changes (per hr): ca. 19
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 31 July To: 9 August 1985

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): test material was warmed prior to dosing and administered as supplied

Duration of treatment / exposure:

3, 30, 60 and 240 min in preliminary test
3 min in main study

Observation period:

0, 24, 48 and 72 h after patch removal

Number of animals:

preliminary test: 2
main study: 3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm square
- % coverage: 10 cm square had been clipped
- Type of wrap if used: impervious Sleek plaster


REMOVAL OF TEST SUBSTANCE
- Washing (if done): after patch removal the tested area was washed with water to remove excess test substance
- Time after start of exposure: after 3, 30, 60 or 240 min of exposure, respectively

SCORING SYSTEM:
EVALUATION OF SKIN REACTIONS
Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) 4

Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by
definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and
extending beyond area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24/48/72 h

Score:

2.67

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: necrosis/blanching was observed at 72 h

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24/48/72 h

Score:

2.83

Max. score:

4

Reversibility:

not reversible

Irritant / corrosive response data:

Preliminary test: severe skin reactions with necrosis, chemical burns and blanching were seen following application for 3, 30, 60
min and 4 h.
Main test: necrotic lesions developed in all 3 animals.

Other effects:

None reported

Any other information on results incl. tables

Summary of dermal lesions following 3-min application (mean of 2 sites per animal)

Animal no.	Effect	Hour	Days after application					Mean score erythema (24/48/72 h)	Mean score oedema (24/48/72 h)
		0	1	2	3	7	14
9401 M	Erythema Oedema	1 0	2 3	2 3	4A 2	- -	- -	2.67	2.67
9411 F	Erythema Oedema	1 0	2 3	2 3	4A 2.5	- -	- -	2.67	2.83
9461 M	Erythema Oedema	1 0	2 3	2 3	4A 3	- -	- -	2.67	3
Mean all animals								2.67	2.83

A = necrosis/blanching

Applicant's summary and conclusion

Interpretation of results:

Category 1A (corrosive) based on GHS criteria

Remarks:

Migrated information

Conclusions:

Slight erythema was observed immediately upon patch removal after a 3-min exposure; necrosis/blanching was observed 3 days
later. Because a response was noted following up to 3 min exposure and up to 1 h observation, the test compound should be
classified in Category 1A according to OECD-GHS.

Executive summary:

A study was performed to assess the irritancy potential of the test material, LILAMIN LS 33, to the skin of the New Zealand White rabbit. The method used essentially followed OECD Test Guideline 404. Following a preliminary test, a single 3 -min occluded application of the test material to the

intact skin of three rabbits produced slight erythema immediately after patch removal. Necrotic lesions developed in all 3 animals after 3 days.

Because a response was noted following up to 3 min exposure and up to 1 h observation, the test compound should be classified in Category 1A according to OECD-GHS.