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Diss Factsheets

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:
From November 21, 1990 to November 24, 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
May, 1981
Deviations:
yes
Remarks:
All three animals were approximately 20 weeks old, instead of maximal 18 weeks, but the body weights were within the range and therefore the animals were still used.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
(2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(3-(diethylammonio)propylamino)-1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate
EC Number:
407-240-9
EC Name:
(2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(3-(diethylammonio)propylamino)-1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate
Cas Number:
159604-94-1
Molecular formula:
C66H88Cu2N20O10S2.C3H5O3.C2H3O2
IUPAC Name:
7,7'-bis[4-(3-diethylaminopropylamino)-6-(3-diethylammoniopropylamino)-1,3,5-triazin-2-ylamino]-{μ-4,4'-dihydroxy-1:2k2O4:O4'-3,3'-[3,3'-dihydroxy-1:2k2O3:O3'-biphenyl-bisazo-1:2(N3,N4-η:N3',N4'-η)]dinaphthalene-2-sulphonato(6-)}dicuprate(2-), mixed (1:1) acetic/lactic acid salts
Test material form:
solid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: Approx. 20 weeks
- Weight at study initiation: 3223 - 3335 grams
- Housing: individually in cages with perforated floors equipped with an automatic drinking systems
- Diet: 100 gram per day
- Water: ad libitum
- Acclimation period: at least five days before start of treatment under test condition.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 55%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial flourescent light / 12 hours dark per day

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: electric clipped
Vehicle:
water
Remarks:
Distilled water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 gram


Duration of treatment / exposure:
4 hours
Observation period:
Skin reaction assessed at 45 minutes, 24, 48 and 72 hours.
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 100 cm2 (10*10 cm)
- Type of wrap if used: Metalline patch (2x3 cm, Lohman, Neuwied, W. -Germany) mounted to Micropore tape (3M, St. Paul , U.S.A.)., secured with an elastic bandage (Coban, 3M, St. Paul , U.S.A.).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): tissue moistened with tap-water and subsequently a dry tissue
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS: minutes and hours

SCORING SYSTEM:
- Method of calculation: The following numerical scoring system was used to grade the skin lesions:
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:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
The observed skin irritation consisted of very slight erythema in all three animals. The irritation was reversible within 24 hours after exposure in all three animals. See tables in "Any other information on results incl. tables"

Any other information on results incl. tables
















































































































45 minutes
Rabbit no.ErythemaOedemaComments
28610Blue staining of treated skin by the test article
28710Blue staining of treated skin by the test article
28910Blue staining of treated skin by the test article
24 hours
Rabbit no.ErythemaOedemaComments
28600Blue staining of treated skin by the test article
28700-
28900Blue staining of treated skin by the test article
48 hours
Rabbit no.ErythemaOedemaComments
28600Blue staining of treated skin by the test article
28700-
28900Blue staining of treated skin by the test article
72 hours
Rabbit no.ErythemaOedemaComments
28600Blue staining of treated skin by the test article
28700-
28900Blue staining of treated skin by the test article

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
Not irritant according to CLP Regulation (EC 1272/2008)
Executive summary:

The purpose of this study was to assess the possible irritation or corrosion potential of the test item when a single dose was placed on the skin of rabbits.


This study was carried out in accordance with OECD Guideline No. 404, "Acute Dermal Irritation / Corrosion' and EEC Directive 84/449/EEC, Part B. 4, "Acute Toxicity - Skin Irritation".


The test item was applied on the shaved skin using semi-occlusive dressings for 4 hours, followed by four observations at approximately 1, 24, 48 and 72 hours after removal of the dressings and the remaining test substance.


Under the conditions of this study, the test item resulted in very slight erythema in all three animals. The erythema was reversible within 24 hours after exposure in all three animals.


In the area of application, blue staining of the treated skin by the test substance was observed.


No corrosive effect occurred on the skin in any of the rabbits.


No signs of systemic intoxication were observed during the study period.


The test item resulted in a primary irritation index of 0 (non irritating) when applied to the intact rabbit skin.