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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2012
Report date:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Cuprate(4-), [2-[[4-chloro-6-[ethyl[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-5-(hydroxy-kO)-6-[2-[2-[2-[2-(hydroxy-kO)-5-sulfophenyl]diazenyl-kN1]-4,5-dimethoxyphenyl]diazenyl-kN2]-1,7-naphthalenedisulfonato(6-)]-, hydrogen sodium (1:2:2)
EC Number:
700-941-3
Cas Number:
1512859-54-9
Molecular formula:
C37H28ClCuN9O19S5 . 2 Na . 2 H
IUPAC Name:
Cuprate(4-), [2-[[4-chloro-6-[ethyl[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-5-(hydroxy-kO)-6-[2-[2-[2-[2-(hydroxy-kO)-5-sulfophenyl]diazenyl-kN1]-4,5-dimethoxyphenyl]diazenyl-kN2]-1,7-naphthalenedisulfonato(6-)]-, hydrogen sodium (1:2:2)

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
erythema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
edema score
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)
Other effects:
Olive staining of the treated skin by the test
substance was observed throughout the observation period,
which did not hamper the scoring of the skin reactions.

No remnants of the test substance were present on the skin.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
There were no systemic adverse effects including effects on clinical signs of toxicity and body weight observed in all animals. The Everzol SB46 did not cause irritant response to skin.

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