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

Endpoint summary

Description of key information

Branched triamine C16-18 is corrosive to skin. Based on this, no studies on eye irritation need to be performed.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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

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

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

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

A study was performed to assess the irritancy potential of Branched triamine C16-18 to the skin of the New Zealand White rabbit. The method 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.

 

Eye irritation

In accordance with Column 2 of REACH Annex VII, the study does not need to be conducted, as the substance is corrosive to skin and the substance will be classified as Eye Dam. 1 , H318.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the results of the available in vivo skin irritation study showing a corrosive response following up to 3 min exposure but not yet observed after 1 hour. In accordance with EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008 the target substance will be classifed as Corrosive Category 1B, H314 (causes severe burns and eye damage). Thus, no further testing to assess the eye irritating potential was needed and the substance will also be classified as Eye Dam 1, H318.