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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:
July 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Justification for type of information:
Refer chapter 13 for the detailed analogue justification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1974

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Trisodium 5-[[4-chloro-6-(methylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
EC Number:
274-417-3
EC Name:
Trisodium 5-[[4-chloro-6-(methylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate
Cas Number:
70210-20-7
Molecular formula:
C26H20ClN7O10S3.3Na
IUPAC Name:
trisodium 5-({4-chloro-6-[methyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(2-sulfonatophenyl)diazenyl]naphthalene-2,7-disulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
FAT 40034/B

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Inhouse breeding
- Age at study initiation: 3 - 4 months
- Weight at study initiation: 2.65 Kgs. (male) and 2.53 Kgs.(female)
- Housing: caged singly
- Diet:commercial irradiated diet (Styles-Oxoid) ad libitum
- Water: Sterile filtered water ad libitum
- Acclimation period: One week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50 - 70
- Photoperiod (hrs dark / hrs light): 10 h light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml. 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad.
Duration of treatment / exposure:
24 h
Observation period:
After 24 h the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 h.
Number of animals:
3 males and 3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Remarks:
males and females
Time point:
other: 24 and 72 h
Score:
0.8
Max. score:
8
Reversibility:
fully reversible within: 72 h
Remarks on result:
other:
Irritation parameter:
erythema score
Remarks:
Intact skin
Basis:
mean
Remarks:
6 rabbits
Time point:
24 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
abraded skin
Basis:
mean
Remarks:
6 rabbits
Time point:
24 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
erythema score
Remarks:
Intact and abraded skin
Basis:
mean
Remarks:
6 rabbits
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Remarks:
Intact and abraded skin
Basis:
mean
Remarks:
6 rabbits
Time point:
72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Remarks:
Intact skin
Basis:
mean
Remarks:
6 rabbits
Time point:
24 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Remarks:
Abraded skin
Basis:
mean
Remarks:
6 rabbits
Time point:
24 h
Score:
1.17
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritation parameter:
edema score
Remarks:
Intact and abraded skin
Basis:
mean
Remarks:
6 rabbits
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Remarks:
Intact and abraded skin
Basis:
mean
Remarks:
6 rabbits
Time point:
72 h
Score:
0
Max. score:
4

Any other information on results incl. tables

Individual Animal Score:

 

Erythema Score

Animal Number

Intact skin

Abraded skin

 

24 h

72 h

24 h

72 h

11

1

0

1

0

13

0

0

0

0

15

1

0

1

0

12

1

0

1

0

14

0

0

0

0

16

0

0

1

0

Mean

0.50

00

0.67

00

 

Edema Score

Animal Number

Intact skin

Abraded skin

 

24 h

72 h

24 h

72 h

11

0

0

1

0

13

0

0

1

0

15

2

0

2

0

12

2

0

1

0

14

0

0

1

0

16

2

0

1

0

Mean

1.00

00

1.17

00

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
FAT 40034/A is to be considered as 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 40034, on the skin of the rabbits according to the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). 6 rabbits (3 males and 3 females), New Zealand White breed, were shaved on the whole back and flanks two days 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 soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape. 10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml. 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad. The gauze patches were removed 24 h after the application. The reaction of the skin was appraised upon removal and 72 h after it. The primary irritation index was calculated as 0.8. The effects were observed to be completely reversible by the end of 72 h. Therefore, FAT 40034/A is to be considered as a non-irritant to the skin of rabbits.