Registration Dossier
Registration Dossier
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EC number: 413-090-5 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 April 1993 to 09 April 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- lithium sodium 2-amino-4-{[4-(cyanoazanidyl)-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl]amino}-5-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)benzene-1-sulfonate
- EC Number:
- 413-090-5
- Cas Number:
- 189574-45-6
- Molecular formula:
- Hill formula: C24H18LixN10NayO12S4
- IUPAC Name:
- lithium sodium 2-amino-4-{[4-(cyanoazanidyl)-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl]amino}-5-(2-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}diazen-1-yl)benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
- Details on test material:
- See below
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Test species: New Zealand albino rabbit
Strain: Chbb: NZW (SPF)
Origin: Chemisch pharmazeutische Fabrik Dr. K. Thomae, 7950 Biberach
Number of animals: 3
Animal identification: numbered ear tags
Animal weights: 2.8 - 3.0 kg
Age of animals: about 3 - 5 months
Animal housing: in fully air-conditioned rooms, separate cages (arranged in a battery)
Ambient temperature: 18 ± 3 °C
Relative humidity: 55 ± 20 %
Lighting time: 12 hours per day
Diet: Altromin 2123 maintenance diet - rabbits (Altromin GmbH, Lage/Lippe), ad libitum and hay (approx. 15 g daily)
Drinking water: deionised, chlorinated water from automatic water dispensers, ad libitum
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- About 24 hours before the start of the study the hair in the dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm2. Only animals with intact skin were used.
Each animal was treated with 0.5 g Reaktiv-Gelb F-68 072 FW pasted with 0.25 ml isotonic saline. The substance was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiers-dorf AG, Hamburg). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.
Examinations of the skin took place after 30 - 60 minutes, and 24, 48 and 72 hours after removal of the patches.
Erythema, eschar formation and oedema were evaluated numerically according to the technique of DRAIZE.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- 30 - 60 minutes after removal of the patches all animals showed very slight erythema and two animals very slight oedema. One day after removal of the patches two animals showed a very slight or a well defined erythema. Two days after removal of the patches a very slight erythema was observed in one animal. Three day after removal of the patches all irritations were reversible.
Any other information on results incl. tables
DRAIZE SKIN TEST RESULTS
ANIMAL NUMBER |
ERYTHEMA |
MEAN SCORE |
OEDEMA |
MEAN SCORE |
||||||
Time after decontamination |
Time after decontamination |
|||||||||
30-60 MIN |
1 DAY |
2 DAYS |
3 DAYS |
30-60 MIN |
1 DAY |
2 DAYS |
3 DAYS |
|||
95 |
1 |
1 |
0 |
0 |
0.3 |
1 |
0 |
0 |
0 |
0.0 |
96 |
1 |
2 |
1 |
0 |
1.0 |
1 |
0 |
0 |
0 |
0.0 |
97 |
1 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0.0 |
|
OVERALL MEAN : 0.4 |
|
OVERALL MEAN: 0.0 |
|
||||||
The means have been calculated using the day 1,2 & 3 values
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study Reaktiv-Gelb F-68 072 FW is not irritating to skin.
- Executive summary:
Testing for primary dermal irritation provides information on the irritant effect of the test substance on the skin following a single dermal application and serves as a basis for classification and labelling.
The present study was conducted in compliance within EEC Directive B.4. 'Acute toxicity Skin Irritation' of the Directive 84/449/EEC and OECD Guidelines for Testing of Chemicals, 404 "Acute Dermal Irritation/Corrosion". This study was conducted in compliance with the Principles of Good Laboratory Practice(GLP).
Testing of Reaktiv-GelbF-68 072FW for primary dermal irritation in the rabbit showed, that the substance is not irritating to skin.
30 - 60 minutes after removal of the patches all animals showed very slight erythema and two animals very slight oedema. One day after removal of the patches two animals showed a very slight or a well defined erythema. Two days after removal of the patches a very slight erythema was observed in one animal. Three day after removal of the patches all irritations were reversible.
Based on the results of this study Reaktiv-GelbF-68072FW is not irritating to skin.
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