Amines, N-(3-aminopropyl)-N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-07-31 to 1985-11-06

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

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:

Triamine C16-18, C18-unsaturated, branched

Cas Number:

1219826-66-0

IUPAC Name:

Triamine C16-18, C18-unsaturated, branched

Constituent 2

Reference substance name:

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

EC Number:

288-048-0

EC Name:

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

IUPAC Name:

288-048-0

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: ad libitum
- Water: ad libitum
- 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:

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:

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 were developed in all 3 animals.

Other effects:

None reported

Any other information on results incl. tables

Table 1: 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 1B (corrosive) based on GHS criteria

Conclusions:

Slight erythema was observed immediately upon patch removal after a 3-min exposure; necrosis/blanching was observed 3 days later. The test compound should be classified in Category 1B according to OECD-GHS.

Executive summary:

In a primary dermal irritation study (equivalent to OECD Guideline 404), following a preliminary test, New Zealand White rabbits (n = 3) were dermally exposed to 0.5 mL of the test material, LILAMIN LS 33 (undiluted material) for 3 min under occlusive conditions. Animals then were observed for 3 days.

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 corrosive response was noted following up to 3 min exposure but not yet observed after 1 hour, the test compound should be classified in Category 1B according to OECD-GHS.