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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:
04 February, 1980 to 26 February, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Principles of method if other than guideline:
None
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Disodium[4-{[5-chloro-2-(hydroxy-O)-3-nitrophenyl]diazenyl-N1}-3-methyl-1-phenyl-1H-pyrazol-5-olato(2-)-O][3-{[1-(3-chlorophenyl)-5-(hydroxy-O)-3-methyl-1H-pyrazol-4-yl]diazenyl-N1}-4-(hydroxy-kO)-5-nitrobenzenesulfonato(3-)]chromate(2-)
Cas Number:
72017-66-4
Molecular formula:
C32H19Na2Cl2CrN10O11S
IUPAC Name:
Disodium[4-{[5-chloro-2-(hydroxy-O)-3-nitrophenyl]diazenyl-N1}-3-methyl-1-phenyl-1H-pyrazol-5-olato(2-)-O][3-{[1-(3-chlorophenyl)-5-(hydroxy-O)-3-methyl-1H-pyrazol-4-yl]diazenyl-N1}-4-(hydroxy-kO)-5-nitrobenzenesulfonato(3-)]chromate(2-)
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Test substance: FAT 20202/B
Additional identification: Physical appearance: powder
Test material received: January 2, 1980

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Bred and raised on the premises
- Weight at study initiation: 2 to 3 kgs
- Housing: They were housed individually in metal cages
- Diet: ad libitum standard rabbit food - NAFAG, No. 814, Gossau SG
- Water: ad libitum water
- Acclimation period: minimum 4 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ±10 %
- Photoperiod: 10 hours light cycle day

IN LIFE PHASE: Experiment start date: 04 February, 1980; Experiment end date: 12 February, 1980

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: shaved abraded on one side and shaved intact on other side
Vehicle:
other: propylene glycol + saline (70 : 30 parts)
Controls:
yes
Amount / concentration applied:
0.5 g of the test material was applied to the prepared abraded and intact site.
Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
3 males and 3 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm²
- Type of wrap if used: The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape.

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

OBSERVATION TIME POINTS
7 days

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
Total possible erythema score 4

Edema formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4
Total possible edema score 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
intact skin
Basis:
mean
Time point:
24/48/72 h
Score:
0.28
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
edema score
Remarks:
intact skin
Basis:
mean
Time point:
24/48/72 h
Score:
0.28
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 4d
Irritation parameter:
edema score
Remarks:
abraded skin
Basis:
mean
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 4d
Irritant / corrosive response data:
None
Other effects:
None

Any other information on results incl. tables

Calculation of the primary skin irritation index - The scores read after 24 and 72 hours for erythema and edema for the intact as well as for the abraded skin were summed up and divided by 4. (FHSLA § 191.11) .

Time after exposure                  mean reactions score
    Erythema     Edema
 Intact Skin  Abraded Skin   Intact Skin   Abraded Skin
24   0.7  0.7  0.7  0.7
 72  0  0.3  0  0.3
 Total  0.7 +  1 +  0.7 +  1  = 3.4

 

primary irritation index = 3.4 : 4 = 0.8

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 20202/B is to be considered as a non-irritant to the skin of rabbits.
Executive summary:

A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 20202/B, on the skin of the rabbits according to the Proposed Guidelines of the United States Environmental Agency (EPA) § 163.81- 5 "Primary dermal irritation study", Federal Register, Vol. 43, No. 163, August 22, 1978. 6 rabbits (3 males and 3 females), New Zealand White breed, were shaved on the whole back and flanks before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch 2.5 x 2.5 cm was laden with 0.5 g of the test substance and immediately applied to the prepared skin. The patch was covered with an impermeable material, which was fixed to the body with adhesive tape. The gauze patches were removed 24 hours after the application. The primary irritation index was calculated as 0.8. The effects were observed to be completely reversible by the end of 72 hours for the intact skin. Therefore, FAT 20202/B is to be considered as a non-irritant to the skin of rabbits.