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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:
1973
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report date:
1973

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Appraisal of the safety of chemicals in foods drugs and cosmetics (1959) AFDO
Principles of method if other than guideline:
Similar to OECD 404 (pre-GLP)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, sodium salts
EC Number:
215-397-8
EC Name:
Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, sodium salts
Cas Number:
1325-54-8
Molecular formula:
Molecular formula of the main constituents: (1) C38H24N8Na4O12S4 (2) C52H32N10Na6O18S6
IUPAC Name:
decasodium 2-[(1E)-2-{2-sulfonato-4-[(1E)-2-{3-sulfonato-4-[(1E)-2-{2-sulfonato-4-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]phenyl}ethenyl]phenyl}diazen-1-yl]phenyl}ethenyl]-5-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzene-1-sulfonate 2-[(1E)-2-{2-sulfonato-4-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]phenyl}ethenyl]-5-[(1E)-2-{4-[(1E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]benzene-1-sulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Lot/Batch No: not specified

Test animals

Species:
rabbit
Strain:
other: Russian breed
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1.5 to 1.6 kg
- Housing: Singly in metal cages, overall dimensions 47x32x34 cm
- Diet (e.g. ad libitum): Nafag
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +- 1
- Humidity (%): 55 +- 5
- Photoperiod (hrs dark / hrs light): 14 hrs light day

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:
24 hours
Observation period:
8 days
Number of animals:
6 rabbits, 3 males and 3 females
Details on study design:
The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied immediatly to the prepared skin. The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape.
FAT 11 030/A was applied to each side in quantities of 0.5 g. Before application the test material was wetted with tap water.
The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 8 days on the basis of erythema and edema formation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
male
Time point:
other: after 24 hours
Score:
> 0.7 - < 3
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
female
Time point:
other: after 24 hours
Score:
> 0.7 - < 2
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
male
Time point:
other: after 48 hours
Score:
> 0.3 - < 2.3
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
female
Time point:
other: after 48 hours
Score:
> 0.3 - < 1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
male
Time point:
other: after 72 hours
Score:
> 0.3 - < 2
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
female
Time point:
other: after 72 hours
Score:
0.3
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
male
Time point:
other: after 4 days
Score:
> 0.3 - < 1
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
female
Time point:
other: after 4 days
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
male
Time point:
other: after 8 days
Score:
> 0 - < 0.6
Max. score:
1
Reversibility:
fully reversible within: 8 days
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
female
Time point:
other: after 8 days
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 8 days

Any other information on results incl. tables

Results tabulated to follow indications according to Guidance on the application of CLP criteria

                  observation time    
   24h  48h  72h  24h  48h  72h          positive >=2.3?          
 animal number        erythema        oedema  mean erythema mean oedema               
 1  1  1  1  1  1  1  1  1  no            
 2  2  1  1  2  1  1  1.3  1.3  no            
 3  2  2  1  1  1  1.7  1.3  no            
 4  2  1  1  2  0  1.3  no            
 5  1  1  0  1  0  0  0.7  0.3  no            
 6  0  0  0  0  0  0  0  0  no            

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
The original study applied criteria US CPSC/US FDA and classified the substance as "moderately irritating".
Preparation of the substance was found to cause minimal irritation (mean reaction score after 24 hours: 0.7) when applied to intact but moderate irritation when applied to abraded rabbit skin (mean reaction score after 24 hours: 2.7).
Executive summary:

6 rabbits (3 males and 3 females) of the Russian breed were dosed with substance in quantities of 0.5 g to the shaved skin area in order to find out the primary irritation index. The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 8 days.