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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:
other: Guideline study without GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
disodium 2-amino-4-acetamido-5-[(E)-2-{4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl]benzene-1-sulfonate
EC Number:
940-436-7
Cas Number:
94158-82-4
Molecular formula:
C16H18N4O10S3.xNa C16H16N4Na2O10S3 as disodium salt
IUPAC Name:
disodium 2-amino-4-acetamido-5-[(E)-2-{4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl]benzene-1-sulfonate
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
see below

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund, konventionelle Zucht
- Age at study initiation: -
- Weight at study initiation: 2 - 3.1 kg
- Housing: single
- Diet (e.g. ad libitum): Alleinfutter für Zuchtkaninchen ERKA Z 6000 (Futtermittelwerke Robert Koch oHG, Hamm/Westfalen), ad libitum
- Water (e.g. ad libitum): deionisiertes; gechlortes Wasser aus automatischen Tränken, ad libitum
- Acclimation period: NA

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12

In-life date: 12. to 15. October 1982

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
physiological saline
Remarks:
0.15 mL to form a paste
Controls:
yes, concurrent no treatment
Amount / concentration applied:
500 mg on 2.5 cm x 2.5 cm gauze pads
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure shaved skin: 2.5x2.5 cm
- Type of wrap if used: Hansamed Wundpflaster and semi-occlusive wrapping

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours


SCORING SYSTEM: OECD guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0.6
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Nach Einwirkung der angeteigten Substanz (4 Stunden Exposition) wurde aufgrund der Befunde der Erythem- und Oedembildung (1, 24, 48, 72 h) ein Reizindex von 0,8 ermittelt. Zusätzlich zu den in den Reizindex eingegangenen Symptomen waren die behandelten Hautstellen nach 30 Minuten großflächig gelb verfärbt Alle Reizerscheinungen waren bis auf eine leichte kaum wahrnehmbare Rötung bei einem Tier bereits innerhalb 48 Stunden nach Entfernung des Patch reversibel.

Unter den beschriebenen Versuchsbedingungen nach der OECO-Richtlinie zur Prüfung auf akute dermale Reizwirkung / Ätzwirkung ist die Substanz Remazol-Goldgelb RNL somit als leicht hautreizend zu bezeichnen.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item was tested according to OECD 404 for skin irritation properties. The evaluation of the erythema and edema scores at the 24, 48, and 72 hour time points showed that the test item is not irritating to skin according to GHS and CLP evaluation schemes.

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