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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:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
EC Number:
308-114-5
EC Name:
Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
Cas Number:
97862-65-2
Molecular formula:
C40H28CrN8O10S2.C28H31N2O3.C20H32N
IUPAC Name:
Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)
Test material form:
solid: particulate/powder
Details on test material:
- Code No.: TK10363
- Batch No.: 42.29
- Physical state: Powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH-4414 Fuellinsdorf
- Weight at study initiation: 2-3 kg
- Housing: Animals were housed individually in metal cages.
- Diet: Rabbit food, NAFAG, No. 814 Tox, NAFAG AG, Gossau, SG (Switzerland), ad libitum.
- Water (e.g. ad libitum): drinking water, ad libitum.
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 +-3 °C
- Humidity: 55 +/- 15 %
- Air changes: 15 per h
- Photoperiod: 12/12 h dark/light

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and intact
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
6 in total. 3 males and 3 females (two treatment sites per animal, one with intact skin, one with abraded skin).
Details on study design:
TEST SITE
- Clipping of the fur: 24 hours before study start, immediatly before treatment the shaven skin as slightly abraded.
- Area of exposure: approximately 6 cm2
- Type of wrap if used: impermeable material

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: The dressings were removed after 24 h.

SCORING SYSTEM: The skin reaction was assessed upon removal and during a subsequent observation period of 7 days on the basis of the evaluation scheme as described in OECD guideline 404 (2002).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
male (intact skin)
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
male (intact skin)
Time point:
other: 24, 48, 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
male (intact skin)
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
female (intact skin)
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
female (intact skin)
Time point:
other: 24, 48, 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
female (intact skin)
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
male (intact skin)
Time point:
other: 24, 48, 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
male (intact skin)
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
male (intact skin)
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
female (intact skin)
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
female (intact skin)
Time point:
other: 24, 48, 72 h
Score:
0.66
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
female (intact skin)
Time point:
other: 24, 48, 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
None of the single animals exceeded an erythema or edema score of 2.

Any other information on results incl. tables

Additional observation made on abraded skin

Irritation parameter

Basis

Time point

Score

Max. score

Reversibility

erythema score

mean male (abraded skin)

24, 48, 72 h

0.33

4

reversible within: 72 h

erythema score

mean female (abraded skin)

24, 48, 72 h

0.77

4

reversible within: 7 days

edema score

mean male (abraded skin)

24, 48, 72 h

0.33

4

reversible within: 72 h

edema score

mean female (abraded skin)

24, 48, 72

0.77

4

reversible within: 7 days

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met

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