Registration Dossier
Registration Dossier
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EC number: 266-405-1 | CAS number: 66557-45-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
- EC Number:
- 258-110-1
- EC Name:
- N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
- Cas Number:
- 52697-38-8
- Molecular formula:
- C18H19BrN6O5
- IUPAC Name:
- N-{2-[(2-bromo-4,6-dinitrophenyl)diazenyl]-5-(diethylamino)phenyl}acetamide
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- HC:NZW Albino Rabbits
Source: : Interfauna UK Ltd
Food: ssniff K 4
Supplier: sniff Spezialdiaten GmbH, Soest/Westfal
Water: Tap water
Food 100 to 120 g per animal per day; once per day in the morning
water ad libitum
Single housing
Weight: 3.1 to 3.3 kg
ENVIRONMENTAL CONDITIONS
- Temperature: 20±3°C
- Humidity: approx. 50 %
- Lighting time: 12 hours daily
In-life date: 18. Oct to 25. Oct. 1988
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- to form a paste
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 500 mg on 6x6 cm2 plaster
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- up to 7 d
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Preparation: about 24h before the start of the study the hair in the dorsal region on the body was removed with an electric clipped and shaved over an area of 6 cm x 6 cm
- Area of exposure: shaved skin 6 cm2
- Type of wrap if used: Fixomull-Stretch as elastic bandage
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 4 hours
SCORING SYSTEM: according to the score of Draize
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No signs of systemic toxicity were observed during the observation period
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In the experimental conditions described by OECD guideline 404 for evaluation of the acute dermal irritation / corrosivity of the substance Disperse Violet 93:1 is detemined to be not irritating to the skin.
- Executive summary:
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 36 cm². Only animals with intact skin were used.
Each animal was treated with 0.5 g Disperse Violet 93:1 pasted with water. The substance was applied over the whole surface of a 6x6 cm² plaster. 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 water.
Examinations of the skin took place after 60 minutes as well as 24, 48 and 72 hours and 7 days after removal of the patches.
Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE. All other changes of the skin were recorded.
No signs of irritation occurred during the whole study.
Testing of Disperse Violet 93:1 for primary dermal irritation in the rabbit showed, that the substance is not irritating to skin.
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