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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 24 SEP 1987 to 10 NOV 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to OECD guideline 404.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Amines, C12-18-alkyldimethyl
EC Number:
269-923-6
EC Name:
Amines, C12-18-alkyldimethyl
Cas Number:
68391-04-8
Molecular formula:
R-N(Me)2, whereas R= C12-18-alkyl (even numbered, unbranched, saturated)
IUPAC Name:
N,N-dimethyl-C12-18-(even numbered)-alkyl-1-amines
Details on test material:
Based on the qualitative and quantitative information on the composition, the sample used is representative of the boundary composition shared and agreed by each registrant.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.35-2.84 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 14-21
- Humidity (%): 45-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 mL of the test material
Duration of treatment / exposure:
3 min, 1 h, 4 h
Observation period:
1, 24, 48 and 72 hours, 7 and 14 days
Number of animals:
6 animals (3 animals for the 4 h exposure time, and 3 animals for 3 minutes and 1 h exposure combined)
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm, gauze patches

REMOVAL OF TEST SUBSTANCE
- test material was removed by gentle swabbing with cotton wool soaked in 3% (v/v) aqueous acetic acid followed by cotton wool soaked distilled water.
- Time after start of exposure: 3 min and 1 h

SCORING SYSTEM:

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 millimetre ):3
Severe oedema (raised more than 1 millimetre extending beyong the area of exposure):4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
test item exposure: 4 h
Time point:
24/48/72 h
Score:
4
Max. score:
4
Reversibility:
other: reversibiliy cannot be determined due to other skin effects
Remarks on result:
other: effects after 14 days: glossy skin, desquamation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
test item exposure: 4h
Time point:
24/48/72 h
Score:
3.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
animal #2 and #3, test item exposure: 4 h
Time point:
24/48/72 h
Score:
3.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
For a detailes list of individual scores see table in section "Any other information on results incl. tables".

Any other information on results incl. tables

three minutes exposure

Skin reaction Reading (hours) Individual scores - rabbit number 1 -3
Erythema / eschar formation 1 1 1 1
24 2 2 2
48 2 2 2
72 2 D 3 D 2 D
7 Days HyCrTL HyCrTL HyCr
14 Days 0 0 0

Oedema formation

1 1 1 1
24 2 2 2
48 2 2 1
72 2 2 1
7 Days 0 0 0
14 Days 0 0 0
         

One hour exposure

Skin reaction Reading (hours) Individual scores - rabbit number 1 -3

Erythema / eschar formation

1 2 1 1
24 2 Br 2 2 Br
48 2 Br 2 2 Br
72 2 Br 2 2 Br
7 Days HyCrTL HyTL HyCrTL
14 Days Fa FaD Fa

Oedema formation

1 2 1 1
24 2 2 2
48 2 2 2
72 2 2 2
7 Days 0 0 0
14 Days 0 0 0

four hour exposure

Skin reaction Reading (hours) Individual scores - rabbit number 4 -6
Erythema / eschar formation 1 2 H 2 H 2 H
24 4 MBE 4 EMB 4 EMB
48 4 WBHE 4 EMB 4 EMB
72 4 WBE 4 EWB 4 EMB
7 Days EHY Eg BsEgHy
14 Days GsD GsD GsD
Total 24, 48 and 72 hours   12 12 12
Mean Values   4 4 4
Oedema formation 1 4 0e 4 0e 3
24 4 0e 4 0e 4 0e
48 4 0e 3 0e 3 0e
72 3 3 3
7 Days 1 1 0
14 Days 0 0 0
Total 24, 48 and 72 hours   11 10 10
Mean Values   3,7 3,3 3,3

B = blanching of skin surrounding treatment site

Fa = abnormal fur growth - fur growing in various directions

Br= brown areas over treatment site

0e= oedema extending ventrally beyond site

D= desquamation

Hy= dry, straw-coloured skin (possible hyperkeratinisation)

Cr= superficial cracking of skin

T= thickening of skin

L= loss of skin suppleness

M= moderate to severe erythema extending beyond treatment site

W= well-definded erythe,a extending beyond treatment site

E= eschar of dry, straw-coloured sin (possible hyperkeratinsation) surrounding eschar

Eg= eschar lifting to reveal glossy skin

Bs= focal areas of dried, blood stained tissue

Gs= glossy skin

D= desquamation

Applicant's summary and conclusion

Interpretation of results:
Category 1C (corrosive) based on GHS criteria
Conclusions:
The test material was found to be corosive to rabbit skin under the conditions of the OECD 404 guideline.
Executive summary:

Test material was subject to a test of skin irritancy according to OECD 404 guideline. 0.5 ml of substance were applied to the skin of six rabbits under semiocclusive conditions for 3 minutes and 1 h (3 animals) and 4 h (3 animals). The scoring of skin reactions was performed 1, 24, 48 and 72 h after end of exposure and after 7 and 14 days. Due to the severe effects on the exposed skin, the test item is classified as corrosive to the skin.