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Toxicological information

Skin irritation / corrosion

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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

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

Resultsopen allclose all
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

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.

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